Cardiovascular DiseasesPhase 3STICHNCT00023595
Comparison of Surgical and Medical Treatment for Congestive Heart Failure and Coronary Artery Disease
A Phase 3 study testing CABG surgery plus MED, Active Medication Alone and CABG plus MED and SVR in people with Cardiovascular Diseases and Coronary Disease, run by Duke University at 1 site in United States.
Trial summary
This study will compare medical therapy with coronary bypass surgery and/or surgical ventricular reconstruction for patients with congestive heart failure and coronary artery disease (CAD). Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Cardiovascular Diseases, Coronary Disease, Heart Failure, Congestive
- What is being tested?
- CABG surgery plus MED, Active Medication Alone and CABG plus MED and SVR
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,136 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2002to Nov 2015
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- LV less than 35%, as defined by echocardiogram, left ventriculogram, CMR, or gated single photon emission computed tomography (SPECT) studies
- Coronary anatomy suitable for revascularization
Who cannot join
- Failure to provide informed consent.
- Aortic valvular heart disease clearly indicating the need for aortic valve repair or replacement.
- Cardiogenic shock (within 72 hours of randomization), as defined by the need for intraaortic balloon support or the requirement for intravenous inotropic support.
- Plan for percutaneous intervention of CAD.
- Recent acute MI judged to be an important cause of left ventricular dysfunction.
- History of more than 1 prior coronary bypass operation.
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- Noncardiac illness with a life expectancy of less than 3 years.
- Noncardiac illness imposing substantial operative mortality.
- Conditions/circumstances likely to lead to poor treatment adherence (eg, history of poor compliance, alcohol or drug dependency, psychiatric illness, no fixed abode).
- Previous heart, kidney, liver, or lung transplantation.
- Current participation in another clinical trial in which a patient is taking an investigational drug or receiving an investigational medical device.
- MED Therapy Eligibility Criteria
- Absence of left main CAD as defined by an intraluminal stenosis of 50% or greater.
- Absence of CCS III angina or greater (angina markedly limiting ordinary activity).
- SVR Eligibility Criterion
- Dominant akinesia or dyskinesia of the anterior left ventricular wall amenable to SVR.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27715
About this study
Official title: Surgical Treatment for Ischemic Heart Failure (STICH)
This study will compare medical therapy with coronary bypass surgery and/or surgical ventricular reconstruction for patients with congestive heart failure and coronary artery disease (CAD).
Read the detailed description
BACKGROUND:
Congestive heart failure afflicts approximately five million Americans and is the leading cause of hospitalization in Americans over the age of 65. Most cases of congestive heart failure are due to CAD. Surprisingly little is known about the relative benefits of medical versus surgical therapy for patients with obstructive coronary disease and congestive heart failure. Randomized studies of medical therapy versus bypass surgery for obstructive coronary disease were conducted in the 1970s and did not include the systematic use of aspirin, arterial conduits, or lipid-lowering medications. In addition, patients with ejection fractions below 35% were specifically excluded from the three large randomized studies of medical therapy versus bypass surgery. While observational data from the 1970s and early 1980s suggest a survival advantage associated with bypass surgery in patients with low ejection fraction and congestive heart failure, biases favoring the referral of the fittest of such patients for bypass surgery may have confounded these comparisons. In addition, medical therapy for congestive heart failure has improved dramatically over the past two decades. Thus, the choice of medical therapy versus bypass surgery for patients with congestive heart failure and obstructive coronary disease is usually decided by guesswork. This study is designed to provide a solid answer.
PURPOSE:
STICH is a multicenter, international, randomized trial that addresses two specific primary hypotheses in patients with clinical heart failure (HF) and left ventricular (LV) dysfunction who have coronary artery disease amenable to surgical revascularization.
The first hypothesis is that restoration of blood flow by means of coronary revascularization recovers chronic LV dysfunction and improves survival, as compared to intensive medical therapy alone. The second hypothesis is that surgical ventricular restoration (SVR) to a more normal LV size improves survival free of subsequent hospitalization for cardiac cause compared to CABG alone.
Patients eligible for either medical therapy or CABG, but not eligible for the SVR procedure (Stratum A), will be randomized in equal proportions to medical therapy alone versus CABG plus medical therapy. Patients eligible for all three therapies (Stratum B) will be randomized in equal proportions to medical therapy alone, CABG plus medical therapy, and CABG plus SVR plus medical therapy. Patients whose severity of angina or CAD makes them inappropriate for medical therapy alone (Stratum C) will be randomized in equal proportions to CABG plus medical therapy versus CABG plus SVR plus medical therapy.
The overall target was to recruit 1200 patients into Hypothesis One and 1,000 patients into Hypothesis Two. Secondary endpoints include the role of myocardial viability, morbidity, economics, and quality of life. Core laboratories for quality of life/economics, cardiac magnetic resonance (CMR), echocardiography (ECHO), neurohormonal/cytokine/genetic (NCG), and radionuclide (RN) studies ensure consistent testing practices and standardization of data necessary to identify eligible patients and to address specific questions related to the stated hypotheses.
IMPORTANCE OF RESEARCH:
The most common cause of HF is no longer hypertension or valvular heart disease as it was in previous decades, but rather CAD. HF is a common worldwide disease and CAD is a frequent cause of HF initiation and progression. HF is responsible for approximately 1 million hospitalizations and 300,000 fatalities annually. The prevalence of HF is increasing, largely due to enhanced survival following acute myocardial infarction and other manifestations of CAD. No randomized trial has ever compared directly the long-term benefits of surgical, medical, or combined surgical and medical treatment of patients with ischemic HF. The STICH trial is the first trial to compare the long term benefits of surgical and medical treatment in patients with ischemic HF. Although modern medical therapy for HF modestly improves quality of life, a more aggressive approach with the surgical therapies being studied in the STICH trial may produce even greater improvements. The common clinical practice of not offering CABG to patients with LV dysfunction in regions found to be nonviable on noninvasive studies is not evidence-based. Since only those patients for whom intensive medical therapy is the only reasonable therapeutic alternative are excluded from this study, the results of the STICH trial should be applicable to most patients with CAD, HF, and systolic LV dysfunction. The results of the STICH trial will also establish whether measurements of neurohormonal and cytokine levels and genetic profiling are useful for directing patient management decisions, for monitoring the effectiveness of therapy, and for refining the optimal approach for selecting the treatment strategy most likely to be effective for the many of these patients.
- Being tested
- CABG surgery plus MED, Active Medication Alone, CABG plus MED and SVR
- Medical subject headings
- Cardiovascular Diseases, Coronary Disease, Heart Failure, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CABG surgery plus MEDProcedure or surgery
CABG plus standard medication management for Coronary Artery Disease
Active Medication AloneDrug
Also called Standard medications for management of CAD and heart failure
Standard medication for coronary artery disease and heart failure management.
CABG plus MED and SVRProcedure or surgery
H02: the experimental arm receives active medical therapy and CABG and surgical ventricular restoration whereas the control group receives active medical therapy and CABG; for H01: the experimental arm receives active medical therapy and CABG whereas the control group receives active medical therapy alone
| Study group | Role | What they receive |
|---|---|---|
| H01: Medication | Active comparator | Medical therapy alone to treat Coronary Artery Disease Receives: Drug: Active Medication Alone |
| H01: Medication + CABG | Active comparator | Coronary artery bypass graft surgery (CABG) plus Medication to treat coronary artery disease Receives: Procedure: CABG surgery plus MED |
| H02: Medication+CABG | Active comparator | Coronary artery bypass graft surgery (CABG) plus Medication to treat coronary artery disease Receives: Procedure: CABG surgery plus MED |
| H02: Medication+CABG+SVR | Active comparator | CABG plus Medication and Surgical ventricular reconstruction (SVR) Receives: Procedure: CABG plus MED and SVR |
What is being measured
The primary outcome is the main question the study is designed to answer.
H01: All Cause Mortality
Measured: 5 years post randomization
H01: All Cause Mortality
Measured: 10 years post randomization
H02: All-cause Mortality or Cardiovascular Hospitalization
Measured: 5 years post randomization
Secondary outcomes (98)
H01: Cardiovascular Mortality (Defined as Sudden Death or Death Attributed to Recurrent MI, HF, a Cardiovascular Procedure, Stroke, or Other Cardiovascular Etiology).
Measured: 10 years post randomization
H01: Cardiovascular Mortality (Defined as Sudden Death or Death Attributed to Recurrent MI, HF, a Cardiovascular Procedure, Stroke, or Other Cardiovascular Etiology).
Measured: 5 years post randomization
H01: Mortality or Cardiovascular Hospitalization
Measured: up to 5 years post randomization
H01: Mortality or Cardiovascular Hospitalization
Measured: up to 10 years post randomization
H02: All-cause Mortality
Measured: up to 5 years
H01: All-cause Mortality Within 30 Days After Randomization
Measured: 30 days post randomization
H02: All-cause Mortality Within 30 Days After Randomization
Measured: 30 days post randomization
H01: All-cause Mortality or Heart-failure Hospitalization
Measured: 5 years post randomization
H02: All-cause Mortality or Heart-failure Hospitalization
Measured: 5 years post randomization
H01: All-cause Mortality or Heart-failure Hospitalization
Measured: 10 years post randomization
H01: Heart Failure Hospitalization
Measured: 5 years post randomization
H02: Heart Failure Hospitalization
Measured: 5 years post randomization
H01: Heart Failure Hospitalization
Measured: 10 years post randomization
H01: Cardiac Procedure: Heart Transplant
Measured: 5 years post randomization
H02: Cardiac Procedure: Heart Transplant
Measured: 5 years post randomization
H01: Cardiac Procedure: Heart Transplant
Measured: 10 years post randomization
H01: Cardiac Procedure: Left Ventricular Assist Device (LVAD)
Measured: 5 years post randomization
H02: Cardiac Procedure: Left Ventricular Assist Device (LVAD)
Measured: 5 years post randomization
H01: Cardiac Procedure: Left Ventricular Assist Device (LVAD)
Measured: 10 years post randomization
H01: Cardiac Procedure: Implantable Cardioverter Defibrillator (ICD)
Measured: 5 years post randomization
H02: Cardiac Procedure: Implantable Cardioverter Defibrillator (ICD)
Measured: 5 years post randomization
H01: Cardiac Procedure: Implantable Cardioverter Defibrillator (ICD)
Measured: 10 years post randomization
H01: Stroke
Measured: 5 years post randomization
H01: Stroke
Measured: 10 years post randomization
H02: Stroke
Measured: 5 years post randomization
H01: All-cause Mortality or Revascularization (CABG or PCI)
CABG = coronary artery bypass grafting. For patients randomized to CABG or CABG +SVR group, this represents the repeat CABG received during follow-up. PCI = Percutaneous Coronary Intervention.
Measured: 5 years post randomization
H02: All-cause Mortality or Revascularization (CABG or PCI)
CABG = coronary artery bypass grafting. For patients randomized to CABG or CABG +SVR group, this represents the repeat CABG received during follow-up. PCI = Percutaneous Coronary Intervention.
Measured: 5 years post randomization
H01: All-cause Mortality or Revascularization (CABG or PCI)
CABG = coronary artery bypass grafting. For patients randomized to CABG or CABG +SVR group, this represents the repeat CABG received during follow-up. PCI = Percutaneous Coronary Intervention.
Measured: 10 years post randomization
H01: All-cause Mortality, Heart Transplant or LVAD
LVAD=Left Ventricular Assist Device
Measured: 5 years post randomization
H02: All-cause Mortality, Heart Transplant or LVAD
Measured: 5 years post randomization
H01: All-cause Mortality, Heart Transplant or LVAD
LVAD=Left Ventricular Assist Device
Measured: 10 years post randomization
H01: All-cause (Unplanned and Elective) Hospitalization
Measured: 5 years post randomization
H02: All-cause (Unplanned and Elective) Hospitalization
Measured: 5 years post randomization
H01: All-cause (Unplanned and Elective) Hospitalization
Measured: 10 years post randomization
H01: 6 Minute Walk Distance
Measured: From randomization to 24 month follow-up
H02: 6 Minute Walk Distance
Measured: From randomization to 24 month follow-up
H01: Exercise Duration
Record the total duration of exercise in minutes and seconds for patients performing the modified Bruce exercise treadmill test
Measured: From randomization to 24 months follow-up
H02: Exercise Duration
Record the total duration of exercise in minutes and seconds for patients performing the modified Bruce exercise treadmill test
Measured: From randomization to 24 months follow-up
H01: LVEF by ECHO Core Lab During Follow-up
Left ventricular ejection fraction (LVEF) measured by Echocardiography (ECHO) core lab
Measured: From randomization to 24 months follow-up
H02: LVEF by ECHO Core Lab During Follow-up
Left ventricular ejection fraction (LVEF) measured by Echocardiography (ECHO) core lab
Measured: From randomization to 24 months follow-up
H01: LVEF by RN Core Lab During Follow-up
Left ventricular ejection fraction (LVEF) measured by radionuclide (RN) core lab.
Measured: From randomization to 24 months follow-up
H02: LVEF by RN Core Lab During Follow-up
Left ventricular ejection fraction (LVEF) measured by radionuclide (RN) core lab.
Measured: From randomization to 24 months follow-up
H01: LVEF by CMR Core Lab During Follow-up
Left ventricular ejection fraction (LVEF) measured by cardiovascular magnetic resonance (CMR) core lab.
Measured: From randomization to 24 months follow-up
H02: LVEF by CMR Core Lab During Follow-up
Left ventricular ejection fraction (LVEF) measured by cardiovascular magnetic resonance (CMR) core lab.
Measured: From randomization to 24 months follow-up
H01: B-type Natriuretic Peptide (BNP)
B-type natriuretic peptide (BNP) by Neurohormonal/cytokine/genetic (NCG) core lab during follow-up
Measured: From randomization to 24 months follow-up
H02: B-type Natriuretic Peptide (BNP)
B-type natriuretic peptide (BNP) by Neurohormonal/cytokine/genetic (NCG) core lab during follow-up
Measured: From randomization to 24 months follow-up
H01: SF-36 Mental Health Subscale
Short Form 36 Health Status Questionnaire (SF-36) Mental Health Subscale: These 5 items assess anxiety, depression, emotional control, and psychological well-being. Response choices range from "All of the time" (1) to "None of the time" (6). Item values are summed and then transformed to a 0-100 scale where higher scores indicate better mental health. (Final scores are normalized to a mean of 50 and standard deviation of 10.)
Measured: From enrollment to 3-year follow-up
H02: SF-36 Mental Health Subscale
These 5 items assess anxiety, depression, emotional control, and psychological well-being. Response choices range from "All of the time" (1) to "None of the time" (6). Item values are summed and then transformed to a 0-100 scale where higher scores indicate better mental health. (Final scores are normalized to a mean of 50 and standard deviation of 10.)
Measured: From enrollment to 3-year follow-up
H01:SF-36 Role Physical Subscale
These 4 items assess limitations and difficulty performing work or other usual activities as a result of one's physical health. Response choices are either "Yes" (1) or "No" (2). Item values are summed and then transformed to a 0-100 scale where higher scores indicate better outcomes. (Final scores are normalized to a mean of 50 and standard deviation of 10.)
Measured: From enrollment to 3-year follow-up
H02: SF-36 Role Physical Subscale
These 4 items assess limitations and difficulty performing work or other usual activities as a result of one's physical health. Response choices are either "Yes" (1) or "No" (2). Item values are summed and then transformed to a 0-100 scale where higher scores indicate better outcomes. (Final scores are normalized to a mean of 50 and standard deviation of 10.)
Measured: From enrollment to 3-year follow-up
H01:SF-36 Role Emotional Subscale
These 3 items assess limitations and difficulty performing work or other usual activities as a result of any emotional problems (such as feeling depressed or anxious). Response choices are either "Yes" (1) or "No" (2). Item values are summed and then transformed to a 0-100 scale where higher scores indicate better outcomes. (Final scores are normalized to a mean of 50 and standard deviation of 10.)
Measured: From enrollment to 3-year follow-up
H02: SF-36 Role Emotional Subscale
These 3 items assess limitations and difficulty performing work or other usual activities as a result of any emotional problems (such as feeling depressed or anxious). Response choices are either "Yes" (1) or "No" (2). Item values are summed and then transformed to a 0-100 scale where higher scores indicate better outcomes. (Final scores are normalized to a mean of 50 and standard deviation of 10.)
Measured: From enrollment to 3-year follow-up
H01:SF-36 Social Functioning Subscale
These 2 items assess the limitations on social activities with others. Response choices range from "Extremely" or "All of the time" (1) to "Not at all" or "None of the time" (5). Item values are summed and then transformed to a 0-100 scale where higher scores indicate better social functioning. (Final scores are normalized to a mean of 50 and standard deviation of 10.)
Measured: From enrollment to 3-year follow-up
H02: SF-36 Social Functioning Subscale
These 2 items assess the limitations on social activities with others. Response choices range from "Extremely" or "All of the time" (1) to "Not at all" or "None of the time" (5). Item values are summed and then transformed to a 0-100 scale where higher scores indicate better social functioning. (Final scores are normalized to a mean of 50 and standard deviation of 10.)
Measured: From enrollment to 3-year follow-up
H01:SF-36 Vitality Subscale
These 4 items assess energy level and fatigue. Response choices range from "All of the time" (1) to "None of the time" (6). Item values are summed and then transformed to a 0-100 scale where higher scores indicate better vitality. (Final scores are normalized to a mean of 50 and standard deviation of 10.)
Measured: From enrollment to 3-year follow-up
H02: SF-36 Vitality Subscale
These 4 items assess energy level and fatigue. Response choices range from "All of the time" (1) to "None of the time" (6). Item values are summed and then transformed to a 0-100 scale where higher scores indicate better vitality. (Final scores are normalized to a mean of 50 and standard deviation of 10.)
Measured: From enrollment to 3-year follow-up
H01:SF-12 Physical Component Summary (PCS) Scale
Twelve items that reflect both physical and mental health are selected from the SF-36 subscales and combined according to an algebraic formula using published weights and constants: (a) First, the items are coded so that a higher value indicates better health; (b) then indicator variables (1/0) are created for the item response choice categories; (c) next, the 35 indicator variables are weighted using "physical" regression weights from the general US population and summed to produce the PCS-12 score; and (d) finally, a normalized score (with a mean of 50 and standard deviation of 10) is obtained by adding the "physical" constant from the scoring table to the sum of the 35 products.
Measured: From enrollment to 3-year follow-up
H02: SF-12 Physical Component Summary (PCS) Scale
Twelve items that reflect both physical and mental health are selected from the SF-36 subscales and combined according to an algebraic formula using published weights and constants: (a) First, the items are coded so that a higher value indicates better health; (b) then indicator variables (1/0) are created for the item response choice categories; (c) next, the 35 indicator variables are weighted using "physical" regression weights from the general US population and summed to produce the PCS-12 score; and (d) finally, a normalized score (with a mean of 50 and standard deviation of 10) is obtained by adding the "physical" constant from the scoring table to the sum of the 35 products.
Measured: From enrollment to 3-year follow-up
H01: SF-12 Mental Component Summary (MCS) Scale
Twelve items that reflect both physical and mental health are selected from the SF-36 subscales and combined according to an algebraic formula using published weights and constants: (a) First, the items are coded so that a higher value indicates better health; (b) then indicator variables (1/0) are created for the item response choice categories; (c) next, the 35 indicator variables are weighted using "mental" regression weights from the general US population and summed to produce the MCS-12 score; and (d) finally, a normalized score (with a mean of 50 and standard deviation of 10) is obtained by adding the "mental" constant from the scoring table to the sum of the 35 products.
Measured: From enrollment to 3-year follow-up
H02: SF-12 Mental Component Summary (MCS) Scale
Twelve items that reflect both physical and mental health are selected from the SF-36 subscales and combined according to an algebraic formula using published weights and constants: (a) First, the items are coded so that a higher value indicates better health; (b) then indicator variables (1/0) are created for the item response choice categories; (c) next, the 35 indicator variables are weighted using "mental" regression weights from the general US population and summed to produce the MCS-12 score; and (d) finally, a normalized score (with a mean of 50 and standard deviation of 10) is obtained by adding the "mental" constant from the scoring table to the sum of the 35 products.
Measured: From enrollment to 3-year follow-up
H01: KCCQ Physical Limitation Scale
Kansas City Cardiomyopathy Questionnaire (KCCQ)Physical Limitation Scale: These 6 items assess ability to perform various activities of daily living. Response choices range from "Extremely limited" (1) to "Not at all limited" (5). Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.
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Measured: From enrollment to 3-year follow-up
H02: KCCQ Physical Limitation Scale
These 6 items assess ability to perform various activities of daily living. Response choices range from "Extremely limited" (1) to "Not at all limited" (5). Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.
Measured: From enrollment to 3-year follow-up
H01: KCCQ Symptom Stability
This item assesses changes in shortness of breath or fatigue over the past 2 weeks. Response choices range from "Much worse" (1) to "Much better" (5). Item score is transformed to a 0-100 scale with a high score representing a better outcome.
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Measured: From enrollment to 3-year follow-up
H02: KCCQ Symptom Stability
This item assesses changes in shortness of breath or fatigue over the past 2 weeks. Response choices range from "Much worse" (1) to "Much better" (5). Item score is transformed to a 0-100 scale with a high score representing a better outcome.
Measured: From enrollment to 3-year follow-up
H01: KCCQ Symptom Frequency
These 4 items assess how many times the patient has been bothered by shortness of breath, fatigue, and ankle swelling over the past 2 weeks. Response choices vary, but they range from "Every morning" or "Every night" or "All of the time" (1) to "Never over the past 2 weeks" (either 5 or 7). Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.
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Measured: From enrollment to 3-year follow-up
H02: KCCQ Symptom Frequency
These 4 items assess how many times the patient has been bothered by shortness of breath, fatigue, and ankle swelling over the past 2 weeks. Response choices vary, but they range from "Every morning" or "Every night" or "All of the time" (1) to "Never over the past 2 weeks" (either 5 or 7). Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.
Measured: From enrollment to 3-year follow-up
H01: KCCQ Symptom Burden
These 3 items assess how much the patient has been bothered by shortness of breath, fatigue, and ankle swelling over the past 2 weeks. Response choices range from "extremely bothersome" (1) to "Not at all bothersome" (5). Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.
Measured: From enrollment to 3-year follow-up
H02: KCCQ Symptom Burden
These 3 items assess how much the patient has been bothered by shortness of breath, fatigue, and ankle swelling over the past 2 weeks. Response choices range from "extremely bothersome" (1) to "Not at all bothersome" (5). Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.
Measured: From enrollment to 3-year follow-up
H01: KCCQ Total Symptoms
This score represents the mean of the Symptom Frequency and Symptom Burden scores. Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.
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Measured: From enrollment to 3-year follow-up
H02: KCCQ Total Symptoms
This score represents the mean of the Symptom Frequency and Symptom Burden scores. Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.
Measured: From enrollment to 3-year follow-up
H01: KCCQ Quality-of-Life Scale
These 3 items assess the effect of heart failure on the patient's enjoyment of life. Response choices range from 1 (worst state) to 5 (best state). Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.
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Measured: From enrollment to 3-year follow-up
H02: KCCQ Quality-of-Life Scale
These 3 items assess the effect of heart failure on the patient's enjoyment of life. Response choices range from 1 (worst state) to 5 (best state). Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.
Measured: From enrollment to 3-year follow-up
H01: KCCQ Social Limitation
These 4 items assess how much heart failure has affected the patient's lifestyle. Response choices range from "Severely limited" (1) to "Did not limit at all" (5). Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.
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Measured: From enrollment to 3-year follow-up
H02: KCCQ Social Limitation
These 4 items assess how much heart failure has affected the patient's lifestyle. Response choices range from "Severely limited" (1) to "Did not limit at all" (5). Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.
Measured: From enrollment to 3-year follow-up
H01: KCCQ Clinical Summary Score
This score represents the mean of the Physical Limitation and Total Symptom scores. Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.
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Measured: From enrollment to 3-year follow-up
H02: KCCQ Clinical Summary Score
This score represents the mean of the Physical Limitation and Total Symptom scores. Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.
Measured: From enrollment to 3-year follow-up
H01: KCCQ Overall Summary Score
This score represents the mean of these 4 scores: Physical Limitation, Total Symptom, Quality of Life, and Social Limitation. Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.
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Measured: From enrollment to 3-year follow-up
H02: KCCQ Overall Summary Score
This score represents the mean of these 4 scores: Physical Limitation, Total Symptom, Quality of Life, and Social Limitation. Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.
Measured: From enrollment to 3-year follow-up
H01: Seattle Angina Questionnaire (SAQ) Anginal Frequency Subscale
These 2 items assess the frequency of chest pain over the last 4 weeks. Response choices range from "4 or more times a day" (1) to "None" (6). The mean response is transformed to a 0-100 scale where higher scores reflect less frequent angina.
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Measured: From enrollment to 3-year follow-up
H02: Seattle Angina Questionnaire (SAQ) Anginal Frequency Subscale
These 2 items assess the frequency of chest pain over the last 4 weeks. Response choices range from "4 or more times a day" (1) to "None" (6). The mean response is transformed to a 0-100 scale where higher scores reflect less frequent angina.
Measured: From enrollment to 3-year follow-up
H01: Seattle Angina Questionnaire (SAQ) Anginal Stability Subscale
This item assesses the change in chest pain over the last 4 weeks. Response choices range from "Much more often" (1) to "None" (6). The mean response is transformed to a 0-100 scale where 50 represents no change and a higher score indicates less angina.
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Measured: From enrollment to 3-year follow-up
H02: Seattle Angina Questionnaire (SAQ) Anginal Stability Subscale
This item assesses the change in chest pain over the last 4 weeks. Response choices range from "Much more often" (1) to "None" (6). The mean response is transformed to a 0-100 scale where 50 represents no change and a higher score indicates less angina.
Measured: From enrollment to 3-year follow-up
H01:Seattle Angina Questionnaire (SAQ) Quality-of-Life Subscale
These 3 items measure the patient's general satisfaction with life. Response choices range from 1 (least enjoyment) to 5 (high satisfaction). The mean score is transformed to a 0-100 scale where higher scores reflect better outcomes.
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Measured: From enrollment to 3-year follow-up
H02: Seattle Angina Questionnaire (SAQ) Quality-of-Life Subscale
These 3 items measure the patient's general satisfaction with life. Response choices range from 1 (least enjoyment) to 5 (high satisfaction). The mean score is transformed to a 0-100 scale where higher scores reflect better outcomes.
Measured: From enrollment to 3-year follow-up
H01: EQ-5D Visual Analog Scale
Euro QoL 5 Dimensions Quality of Life Instrument (EQ-5D): This 0-100 scale records the patient's self-rated health on a vertical scale where 0 = worst imaginable health and 100 = perfect health.
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Measured: From enrollment to 3-year follow-up
H02: EQ-5D Visual Analog Scale
This 0-100 scale records the patient's self-rated health on a vertical scale where 0 = worst imaginable health and 100 = perfect health.
Measured: From enrollment to 3-year follow-up
H01: EQ-5D Health Status Index Score
This 5-item scale describes a patient's health in terms of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Choices for each dimension are "No problems" (1), "Moderate problems" (2), or "Extreme problems" (3). A scoring algorithm with utility weights is then applied to these 5 items to generate index scores ranging from -0.11 (i.e., 33333) to 1.0 (i.e., 11111) on a scale where 0.0 = death and 1.0 = perfect health. These scores were multiplied by 100 to produce a scale from -11 to 100 that more closely resembles the Visual Analog Scale.
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Measured: From enrollment to 3-year follow-up
H02: EQ-5D Health Status Index Score
This 5-item scale describes a patient's health in terms of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Choices for each dimension are "No problems" (1), "Moderate problems" (2), or "Extreme problems" (3). A scoring algorithm with utility weights is then applied to these 5 items to generate index scores ranging from -0.11 (i.e., 33333) to 1.0 (i.e., 11111) on a scale where 0.0 = death and 1.0 = perfect health. (These scores can be multiplied by 100 to produce a scale from -11 to 100 that more closely resembles the Visual Analog Scale.)
Measured: From enrollment to 3-year follow-up
H01: Percentage of Patients With a Score of >= 16 on the Center for Epidemiological Studies Depression (CES-D) Scale
These 20 items assess depressive symptomatology, and responses choices range from "Rarely or none of the time" (0) to "Most or all of the time" (3). Scale scores can therefore range from 0 to 60, although scores greater than or equal to 16 are considered high.
.
Measured: From enrollment to 3-year follow-up
H02: Percentage of Patients With a Score of >= 16 on the Center for Epidemiological Studies Depression (CES-D) Scale
These 20 items assess depressive symptomatology, and responses choices range from "Rarely or none of the time" (0) to "Most or all of the time" (3). Scale scores can therefore range from 0 to 60, although scores greater than or equal to 16 are considered high.
Measured: From enrollment to 3-year follow-up
H01: Cardiac Self-Efficacy (CSE) Maintain Functioning Subscale
These 5 items assess patients' ability to maintain their usual social, family, and physical activities. Response choices range from "Not at all confident" (1) to "Completely confident" (5). The mean score is transformed to a 0-100 scale where higher scores reflect more confidence.
.
Measured: From enrollment to 3-year follow-up
H02: Cardiac Self-Efficacy (CSE) Maintain Functioning Subscale
These 5 items assess patients' ability to maintain their usual social, family, and physical activities. Response choices range from "Not at all confident" (1) to "Completely confident" (5). The mean score is transformed to a 0-100 scale where higher scores reflect more confidence.
Measured: From enrollment to 3-year follow-up
H01: Cardiac Self-Efficacy (CSE) Control Symptoms Subscale
These 8 items assess patients' ability to control symptoms such as chest pain and breathlessness by taking their medications and adjusting their activity levels. Response choices range from "Not at all confident" (1) to "Completely confident" (5). The mean score is transformed to a 0-100 scale where higher scores reflect more confidence.
.
Measured: From enrollment to 3-year follow-up
H02: Cardiac Self-Efficacy (CSE) Control Symptoms Subscale
These 8 items assess patients' ability to control symptoms such as chest pain and breathlessness by taking their medications and adjusting their activity levels. Response choices range from "Not at all confident" (1) to "Completely confident" (5). The mean score is transformed to a 0-100 scale where higher scores reflect more confidence.
Measured: From enrollment to 3-year follow-up
H01: General Health Rating Scale
This single item asks patients to describe their health status over the past month on a scale from 0 to 100, where 0 = death and 100 = excellent health.
.
Measured: From enrollment to 3-year follow-up
H02: General Health Rating Scale
This single item asks patients to describe their health status over the past month on a scale from 0 to 100, where 0 = death and 100 = excellent health.
Measured: From enrollment to 3-year follow-up
H01: Cost of Care
Hospital costs and physician fees for US patients
Measured: index hospital admission
H02: Cost of Care
Hospital costs and physician fees for US patients
Measured: index hospital admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2001 (estimated)
- Study startJan 2002
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (36)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Robert Bonow, Principal investigator, Radionuclide Core Lab, Northwestern UniversityArthur Feldman, Principal investigator, Neurohormonal Core Lab, Jefferson UniversityEric Velazquez, MD, Principal investigator, Clinical Coordinating Center, Duke UniversityKerry Lee, Principal investigator, Data Coordinating Center, Duke UniversityDaniel Mark, Principal investigator, Economics and Quality of Life Core Lab, Duke UniversityJae Oh, Principal investigator, Echocardiographic Core Lab, Mayo ClinicGerald Pohost, Principal investigator, Magnetic Resonance Imaging Core Lab, University of Southern CaliforniaJean Rouleau, Study chair, Université de Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00023595
- Sponsor's protocol ID
- Pro00018940
- Other IDs
- U01HL069009, U01HL069010, U01HL069011, U01HL069012, U01HL069013, U01HL069015, U01HL072683, R01HL105853
- Acronym
- STICH
- Status last verified
- Sep 2019
- First submitted
- 11 Sep 2001
- Last updated
- 19 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Velazquez EJ, Lee KL, O'Connor CM, Oh JK, Bonow RO, Pohost GM, Feldman AM, Mark DB, Panza JA, Sopko G, Rouleau JL, Jones RH; STICH Investigators. The rationale and design of the Surgical Treatment for Ischemic Heart Failure (STICH) trial. J Thorac Cardiovasc Surg. 2007 Dec;134(6):1540-7. doi: 10.1016/j.jtcvs.2007.05.069.
PubMed 18023680Zhou Z, Jian B, Chen X, Liu M, Zhang S, Fu G, Li G, Liang M, Tian T, Wu Z. Heterogeneous treatment effects of coronary artery bypass grafting in ischemic cardiomyopathy: A machine learning causal forest analysis. J Thorac Cardiovasc Surg. 2024 Nov;168(5):1462-1471.e7. doi: 10.1016/j.jtcvs.2023.09.021. Epub 2023 Sep 15.
PubMed 37716652Wen B, Lu Y, Huang X, Du X, Sun F, Xie F, Liu C, Wang D. Influence and risk factors of postoperative infection after surgery for ischemic cardiomyopathy. Front Cardiovasc Med. 2023 Aug 24;10:1231556. doi: 10.3389/fcvm.2023.1231556. eCollection 2023.
PubMed 37692042Ezad SM, Ryan M, Perera D. Can Percutaneous Coronary Intervention Revive a Failing Heart? Heart Int. 2022 Dec 21;16(2):72-74. doi: 10.17925/HI.2022.16.2.72. eCollection 2022.
PubMed 36741102Chew DS, Cowper PA, Al-Khalidi H, Anstrom KJ, Daniels MR, Davidson-Ray L, Li Y, Michler RE, Panza JA, Pina IL, Rouleau JL, Velazquez EJ, Mark DB; STICH Investigators. Cost-Effectiveness of Coronary Artery Bypass Surgery Versus Medicine in Ischemic Cardiomyopathy: The STICH Randomized Clinical Trial. Circulation. 2022 Mar 15;145(11):819-828. doi: 10.1161/CIRCULATIONAHA.121.056276. Epub 2022 Jan 19.
PubMed 35044802Farsky PS, White J, Al-Khalidi HR, Sueta CA, Rouleau JL, Panza JA, Velazquez EJ, O'Connor CM; Working Group and Surgical Treatment for Ischemic Heart Failure Trial Investigators. Optimal medical therapy with or without surgical revascularization and long-term outcomes in ischemic cardiomyopathy. J Thorac Cardiovasc Surg. 2022 Dec;164(6):1890-1899.e4. doi: 10.1016/j.jtcvs.2020.12.094. Epub 2021 Jan 7.
PubMed 33610365Perry AS, Mann DL, Brown DL. Improvement of ejection fraction and mortality in ischaemic heart failure. Heart. 2020 Aug 25:heartjnl-2020-316975. doi: 10.1136/heartjnl-2020-316975. Online ahead of print.
PubMed 32843496Howlett JG, Stebbins A, Petrie MC, Jhund PS, Castelvecchio S, Cherniavsky A, Sueta CA, Roy A, Pina IL, Wurm R, Drazner MH, Andersson B, Batlle C, Senni M, Chrzanowski L, Merkely B, Carson P, Desvigne-Nickens PM, Lee KL, Velazquez EJ, Al-Khalidi HR; STICH Trial Investigators. CABG Improves Outcomes in Patients With Ischemic Cardiomyopathy: 10-Year Follow-Up of the STICH Trial. JACC Heart Fail. 2019 Oct;7(10):878-887. doi: 10.1016/j.jchf.2019.04.018. Epub 2019 Sep 11.
PubMed 31521682Panza JA, Ellis AM, Al-Khalidi HR, Holly TA, Berman DS, Oh JK, Pohost GM, Sopko G, Chrzanowski L, Mark DB, Kukulski T, Favaloro LE, Maurer G, Farsky PS, Tan RS, Asch FM, Velazquez EJ, Rouleau JL, Lee KL, Bonow RO. Myocardial Viability and Long-Term Outcomes in Ischemic Cardiomyopathy. N Engl J Med. 2019 Aug 22;381(8):739-748. doi: 10.1056/NEJMoa1807365.
PubMed 31433921Nicolau JC, Stevens SR, Al-Khalidi HR, Jatene FB, Furtado RHM, Dallan LAO, Lisboa LAF, Desvigne-Nickens P, Haddad H, Jolicoeur EM, Petrie MC, Doenst T, Michler RE, Ohman EM, Maddury J, Ali I, Deja MA, Rouleau JL, Velazquez EJ, Hill JA. Does prior coronary angioplasty affect outcomes of surgical coronary revascularization? Insights from the STICH trial. Int J Cardiol. 2019 Sep 15;291:36-41. doi: 10.1016/j.ijcard.2019.03.029. Epub 2019 Mar 15.
PubMed 30929973Ambrosy AP, Stevens SR, Al-Khalidi HR, Rouleau JL, Bouabdallaoui N, Carson PE, Adlbrecht C, Cleland JGF, Dabrowski R, Golba KS, Pina IL, Sueta CA, Roy A, Sopko G, Bonow RO, Velazquez EJ; STICH Trial Investigators. Burden of medical co-morbidities and benefit from surgical revascularization in patients with ischaemic cardiomyopathy. Eur J Heart Fail. 2019 Mar;21(3):373-381. doi: 10.1002/ejhf.1404. Epub 2019 Jan 30.
PubMed 30698316Pellikka PA, She L, Holly TA, Lin G, Varadarajan P, Pai RG, Bonow RO, Pohost GM, Panza JA, Berman DS, Prior DL, Asch FM, Borges-Neto S, Grayburn P, Al-Khalidi HR, Miszalski-Jamka K, Desvigne-Nickens P, Lee KL, Velazquez EJ, Oh JK. Variability in Ejection Fraction Measured By Echocardiography, Gated Single-Photon Emission Computed Tomography, and Cardiac Magnetic Resonance in Patients With Coronary Artery Disease and Left Ventricular Dysfunction. JAMA Netw Open. 2018 Aug 3;1(4):e181456. doi: 10.1001/jamanetworkopen.2018.1456.
PubMed 30646130Bouabdallaoui N, Stevens SR, Doenst T, Petrie MC, Al-Attar N, Ali IS, Ambrosy AP, Barton AK, Cartier R, Cherniavsky A, Demondion P, Desvigne-Nickens P, Favaloro RR, Gradinac S, Heinisch P, Jain A, Jasinski M, Jouan J, Kalil RAK, Menicanti L, Michler RE, Rao V, Smith PK, Zembala M, Velazquez EJ, Al-Khalidi HR, Rouleau JL; STICH Trial Investigators. Society of Thoracic Surgeons Risk Score and EuroSCORE-2 Appropriately Assess 30-Day Postoperative Mortality in the STICH Trial and a Contemporary Cohort of Patients With Left Ventricular Dysfunction Undergoing Surgical Revascularization. Circ Heart Fail. 2018 Nov;11(11):e005531. doi: 10.1161/CIRCHEARTFAILURE.118.005531.
PubMed 30571194Andersson B, She L, Tan RS, Jeemon P, Mokrzycki K, Siepe M, Romanov A, Favaloro LE, Djokovic LT, Raju PK, Betlejewski P, Racine N, Ostrzycki A, Nawarawong W, Das S, Rouleau JL, Sopko G, Lee KL, Velazquez EJ, Panza JA. The association between blood pressure and long-term outcomes of patients with ischaemic cardiomyopathy with and without surgical revascularization: an analysis of the STICH trial. Eur Heart J. 2018 Oct 1;39(37):3464-3471. doi: 10.1093/eurheartj/ehy438.
PubMed 30113633Stewart RAH, Szalewska D, Stebbins A, Al-Khalidi HR, Cleland JGH, Rynkiewicz A, Drazner MH, White HD, Mark DB, Roy A, Kosevic D, Rajda M, Jasinski M, Leng CY, Tungsubutra W, Desvigne-Nickens P, Velazquez EJ, Petrie MC. Six-minute walk distance after coronary artery bypass grafting compared with medical therapy in ischaemic cardiomyopathy. Open Heart. 2018 Feb 20;5(1):e000752. doi: 10.1136/openhrt-2017-000752. eCollection 2018.
PubMed 29531766
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Treatment for Ischemic Heart Failure (STICH)
- ClinicalTrials.gov ID
- NCT00023595
- Acronym / sponsor ID
- STICH / Pro00018940
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,136 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jan 2002
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 11 Sep 2001 (estimated)
- Results
- Posted 24 Jul 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will compare medical therapy with coronary bypass surgery and/or surgical ventricular reconstruction for patients with congestive heart failure and coronary artery disease (CAD).
Detailed description
BACKGROUND:
Congestive heart failure afflicts approximately five million Americans and is the leading cause of hospitalization in Americans over the age of 65. Most cases of congestive heart failure are due to CAD. Surprisingly little is known about the relative benefits of medical versus surgical therapy for patients with obstructive coronary disease and congestive heart failure. Randomized studies of medical therapy versus bypass surgery for obstructive coronary disease were conducted in the 1970s and did not include the systematic use of aspirin, arterial conduits, or lipid-lowering medications. In addition, patients with ejection fractions below 35% were specifically excluded from the three large randomized studies of medical therapy versus bypass surgery. While observational data from the 1970s and early 1980s suggest a survival advantage associated with bypass surgery in patients with low ejection fraction and congestive heart failure, biases favoring the referral of the fittest of such patients for bypass surgery may have confounded these comparisons. In addition, medical therapy for congestive heart failure has improved dramatically over the past two decades. Thus, the choice of medical therapy versus bypass surgery for patients with congestive heart failure and obstructive coronary disease is usually decided by guesswork. This study is designed to provide a solid answer.
PURPOSE:
STICH is a multicenter, international, randomized trial that addresses two specific primary hypotheses in patients with clinical heart failure (HF) and left ventricular (LV) dysfunction who have coronary artery disease amenable to surgical revascularization.
The first hypothesis is that restoration of blood flow by means of coronary revascularization recovers chronic LV dysfunction and improves survival, as compared to intensive medical therapy alone. The second hypothesis is that surgical ventricular restoration (SVR) to a more normal LV size improves survival free of subsequent hospitalization for cardiac cause compared to CABG alone.
Patients eligible for either medical therapy or CABG, but not eligible for the SVR procedure (Stratum A), will be randomized in equal proportions to medical therapy alone versus CABG plus medical therapy. Patients eligible for all three therapies (Stratum B) will be randomized in equal proportions to medical therapy alone, CABG plus medical therapy, and CABG plus SVR plus medical therapy. Patients whose severity of angina or CAD makes them inappropriate for medical therapy alone (Stratum C) will be randomized in equal proportions to CABG plus medical therapy versus CABG plus SVR plus medical therapy.
The overall target was to recruit 1200 patients into Hypothesis One and 1,000 patients into Hypothesis Two. Secondary endpoints include the role of myocardial viability, morbidity, economics, and quality of life. Core laboratories for quality of life/economics, cardiac magnetic resonance (CMR), echocardiography (ECHO), neurohormonal/cytokine/genetic (NCG), and radionuclide (RN) studies ensure consistent testing practices and standardization of data necessary to identify eligible patients and to address specific questions related to the stated hypotheses.
IMPORTANCE OF RESEARCH:
The most common cause of HF is no longer hypertension or valvular heart disease as it was in previous decades, but rather CAD. HF is a common worldwide disease and CAD is a frequent cause of HF initiation and progression. HF is responsible for approximately 1 million hospitalizations and 300,000 fatalities annually. The prevalence of HF is increasing, largely due to enhanced survival following acute myocardial infarction and other manifestations of CAD. No randomized trial has ever compared directly the long-term benefits of surgical, medical, or combined surgical and medical treatment of patients with ischemic HF. The STICH trial is the first trial to compare the long term benefits of surgical and medical treatment in patients with ischemic HF. Although modern medical therapy for HF modestly improves quality of life, a more aggressive approach with the surgical therapies being studied in the STICH trial may produce even greater improvements. The common clinical practice of not offering CABG to patients with LV dysfunction in regions found to be nonviable on noninvasive studies is not evidence-based. Since only those patients for whom intensive medical therapy is the only reasonable therapeutic alternative are excluded from this study, the results of the STICH trial should be applicable to most patients with CAD, HF, and systolic LV dysfunction. The results of the STICH trial will also establish whether measurements of neurohormonal and cytokine levels and genetic profiling are useful for directing patient management decisions, for monitoring the effectiveness of therapy, and for refining the optimal approach for selecting the treatment strategy most likely to be effective for the many of these patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| H01: Medication | Active comparator | Drug: Active Medication AloneMedical therapy alone to treat Coronary Artery Disease |
| H01: Medication + CABG | Active comparator | Procedure: CABG surgery plus MEDCoronary artery bypass graft surgery (CABG) plus Medication to treat coronary artery disease |
| H02: Medication+CABG | Active comparator | Procedure: CABG surgery plus MEDCoronary artery bypass graft surgery (CABG) plus Medication to treat coronary artery disease |
| H02: Medication+CABG+SVR | Active comparator | Procedure: CABG plus MED and SVRCABG plus Medication and Surgical ventricular reconstruction (SVR) |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- LV less than 35%, as defined by echocardiogram, left ventriculogram, CMR, or gated single photon emission computed tomography (SPECT) studies
- Coronary anatomy suitable for revascularization
Key exclusion criteria (16 listed)
- Failure to provide informed consent.
- Aortic valvular heart disease clearly indicating the need for aortic valve repair or replacement.
- Cardiogenic shock (within 72 hours of randomization), as defined by the need for intraaortic balloon support or the requirement for intravenous inotropic support.
- Plan for percutaneous intervention of CAD.
- Recent acute MI judged to be an important cause of left ventricular dysfunction.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CABG surgery plus MEDCABG plus standard medication management for Coronary Artery Disease | Procedure or surgery | H01: Medication + CABG, H02: Medication+CABG |
| Active Medication AloneAlso: Standard medications for management of CAD and heart failureStandard medication for coronary artery disease and heart failure management. | Drug | H01: Medication |
| CABG plus MED and SVRH02: the experimental arm receives active medical therapy and CABG and surgical ventricular restoration whereas the control group receives active medical therapy and CABG; for H01: the experimental arm receives active medical therapy and CABG whereas the control group receives active medical therapy alone | Procedure or surgery | H02: Medication+CABG+SVR |
Primary outcome
H01: All Cause Mortality
Time frame: 5 years post randomization
H01: All Cause Mortality
Time frame: 10 years post randomization
H02: All-cause Mortality or Cardiovascular Hospitalization
Time frame: 5 years post randomization
98 secondary outcomes
H01: Cardiovascular Mortality (Defined as Sudden Death or Death Attributed to Recurrent MI, HF, a Cardiovascular Procedure, Stroke, or Other Cardiovascular Etiology).
Time frame: 10 years post randomization
H01: Cardiovascular Mortality (Defined as Sudden Death or Death Attributed to Recurrent MI, HF, a Cardiovascular Procedure, Stroke, or Other Cardiovascular Etiology).
Time frame: 5 years post randomization
H01: Mortality or Cardiovascular Hospitalization
Time frame: up to 5 years post randomization
H01: Mortality or Cardiovascular Hospitalization
Time frame: up to 10 years post randomization
H02: All-cause Mortality
Time frame: up to 5 years
H01: All-cause Mortality Within 30 Days After Randomization
Time frame: 30 days post randomization
H02: All-cause Mortality Within 30 Days After Randomization
Time frame: 30 days post randomization
H01: All-cause Mortality or Heart-failure Hospitalization
Time frame: 5 years post randomization
H02: All-cause Mortality or Heart-failure Hospitalization
Time frame: 5 years post randomization
H01: All-cause Mortality or Heart-failure Hospitalization
Time frame: 10 years post randomization
H01: Heart Failure Hospitalization
Time frame: 5 years post randomization
H02: Heart Failure Hospitalization
Time frame: 5 years post randomization
H01: Heart Failure Hospitalization
Time frame: 10 years post randomization
H01: Cardiac Procedure: Heart Transplant
Time frame: 5 years post randomization
H02: Cardiac Procedure: Heart Transplant
Time frame: 5 years post randomization
H01: Cardiac Procedure: Heart Transplant
Time frame: 10 years post randomization
H01: Cardiac Procedure: Left Ventricular Assist Device (LVAD)
Time frame: 5 years post randomization
H02: Cardiac Procedure: Left Ventricular Assist Device (LVAD)
Time frame: 5 years post randomization
H01: Cardiac Procedure: Left Ventricular Assist Device (LVAD)
Time frame: 10 years post randomization
H01: Cardiac Procedure: Implantable Cardioverter Defibrillator (ICD)
Time frame: 5 years post randomization
H02: Cardiac Procedure: Implantable Cardioverter Defibrillator (ICD)
Time frame: 5 years post randomization
H01: Cardiac Procedure: Implantable Cardioverter Defibrillator (ICD)
Time frame: 10 years post randomization
H01: Stroke
Time frame: 5 years post randomization
H01: Stroke
Time frame: 10 years post randomization
H02: Stroke
Time frame: 5 years post randomization
H01: All-cause Mortality or Revascularization (CABG or PCI)
Time frame: 5 years post randomization
H02: All-cause Mortality or Revascularization (CABG or PCI)
Time frame: 5 years post randomization
H01: All-cause Mortality or Revascularization (CABG or PCI)
Time frame: 10 years post randomization
H01: All-cause Mortality, Heart Transplant or LVAD
Time frame: 5 years post randomization
H02: All-cause Mortality, Heart Transplant or LVAD
Time frame: 5 years post randomization
H01: All-cause Mortality, Heart Transplant or LVAD
Time frame: 10 years post randomization
H01: All-cause (Unplanned and Elective) Hospitalization
Time frame: 5 years post randomization
H02: All-cause (Unplanned and Elective) Hospitalization
Time frame: 5 years post randomization
H01: All-cause (Unplanned and Elective) Hospitalization
Time frame: 10 years post randomization
H01: 6 Minute Walk Distance
Time frame: From randomization to 24 month follow-up
H02: 6 Minute Walk Distance
Time frame: From randomization to 24 month follow-up
H01: Exercise Duration
Time frame: From randomization to 24 months follow-up
H02: Exercise Duration
Time frame: From randomization to 24 months follow-up
H01: LVEF by ECHO Core Lab During Follow-up
Time frame: From randomization to 24 months follow-up
H02: LVEF by ECHO Core Lab During Follow-up
Time frame: From randomization to 24 months follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 18023680Velazquez EJ, Lee KL, O'Connor CM, Oh JK, Bonow RO, Pohost GM, Feldman AM, Mark DB, Panza JA, Sopko G, Rouleau JL, Jones RH; STICH Investigators. The rationale and design of the Surgical Treatment for Ischemic Heart Failure (STICH) trial. J Thorac Cardiovasc Surg. 2007 Dec;134(6):1540-7. doi: 10.1016/j.jtcvs.2007.05.069.
- Derived from this study: PubMed 37716652Zhou Z, Jian B, Chen X, Liu M, Zhang S, Fu G, Li G, Liang M, Tian T, Wu Z. Heterogeneous treatment effects of coronary artery bypass grafting in ischemic cardiomyopathy: A machine learning causal forest analysis. J Thorac Cardiovasc Surg. 2024 Nov;168(5):1462-1471.e7. doi: 10.1016/j.jtcvs.2023.09.021. Epub 2023 Sep 15.
- Derived from this study: PubMed 37692042Wen B, Lu Y, Huang X, Du X, Sun F, Xie F, Liu C, Wang D. Influence and risk factors of postoperative infection after surgery for ischemic cardiomyopathy. Front Cardiovasc Med. 2023 Aug 24;10:1231556. doi: 10.3389/fcvm.2023.1231556. eCollection 2023.
- Derived from this study: PubMed 36741102Ezad SM, Ryan M, Perera D. Can Percutaneous Coronary Intervention Revive a Failing Heart? Heart Int. 2022 Dec 21;16(2):72-74. doi: 10.17925/HI.2022.16.2.72. eCollection 2022.
- Derived from this study: PubMed 35044802Chew DS, Cowper PA, Al-Khalidi H, Anstrom KJ, Daniels MR, Davidson-Ray L, Li Y, Michler RE, Panza JA, Pina IL, Rouleau JL, Velazquez EJ, Mark DB; STICH Investigators. Cost-Effectiveness of Coronary Artery Bypass Surgery Versus Medicine in Ischemic Cardiomyopathy: The STICH Randomized Clinical Trial. Circulation. 2022 Mar 15;145(11):819-828. doi: 10.1161/CIRCULATIONAHA.121.056276. Epub 2022 Jan 19.
- Derived from this study: PubMed 33610365Farsky PS, White J, Al-Khalidi HR, Sueta CA, Rouleau JL, Panza JA, Velazquez EJ, O'Connor CM; Working Group and Surgical Treatment for Ischemic Heart Failure Trial Investigators. Optimal medical therapy with or without surgical revascularization and long-term outcomes in ischemic cardiomyopathy. J Thorac Cardiovasc Surg. 2022 Dec;164(6):1890-1899.e4. doi: 10.1016/j.jtcvs.2020.12.094. Epub 2021 Jan 7.
- Derived from this study: PubMed 32843496Perry AS, Mann DL, Brown DL. Improvement of ejection fraction and mortality in ischaemic heart failure. Heart. 2020 Aug 25:heartjnl-2020-316975. doi: 10.1136/heartjnl-2020-316975. Online ahead of print.
- Derived from this study: PubMed 31521682Howlett JG, Stebbins A, Petrie MC, Jhund PS, Castelvecchio S, Cherniavsky A, Sueta CA, Roy A, Pina IL, Wurm R, Drazner MH, Andersson B, Batlle C, Senni M, Chrzanowski L, Merkely B, Carson P, Desvigne-Nickens PM, Lee KL, Velazquez EJ, Al-Khalidi HR; STICH Trial Investigators. CABG Improves Outcomes in Patients With Ischemic Cardiomyopathy: 10-Year Follow-Up of the STICH Trial. JACC Heart Fail. 2019 Oct;7(10):878-887. doi: 10.1016/j.jchf.2019.04.018. Epub 2019 Sep 11.
- Derived from this study: PubMed 31433921Panza JA, Ellis AM, Al-Khalidi HR, Holly TA, Berman DS, Oh JK, Pohost GM, Sopko G, Chrzanowski L, Mark DB, Kukulski T, Favaloro LE, Maurer G, Farsky PS, Tan RS, Asch FM, Velazquez EJ, Rouleau JL, Lee KL, Bonow RO. Myocardial Viability and Long-Term Outcomes in Ischemic Cardiomyopathy. N Engl J Med. 2019 Aug 22;381(8):739-748. doi: 10.1056/NEJMoa1807365.
- Derived from this study: PubMed 30929973Nicolau JC, Stevens SR, Al-Khalidi HR, Jatene FB, Furtado RHM, Dallan LAO, Lisboa LAF, Desvigne-Nickens P, Haddad H, Jolicoeur EM, Petrie MC, Doenst T, Michler RE, Ohman EM, Maddury J, Ali I, Deja MA, Rouleau JL, Velazquez EJ, Hill JA. Does prior coronary angioplasty affect outcomes of surgical coronary revascularization? Insights from the STICH trial. Int J Cardiol. 2019 Sep 15;291:36-41. doi: 10.1016/j.ijcard.2019.03.029. Epub 2019 Mar 15.
- Derived from this study: PubMed 30698316Ambrosy AP, Stevens SR, Al-Khalidi HR, Rouleau JL, Bouabdallaoui N, Carson PE, Adlbrecht C, Cleland JGF, Dabrowski R, Golba KS, Pina IL, Sueta CA, Roy A, Sopko G, Bonow RO, Velazquez EJ; STICH Trial Investigators. Burden of medical co-morbidities and benefit from surgical revascularization in patients with ischaemic cardiomyopathy. Eur J Heart Fail. 2019 Mar;21(3):373-381. doi: 10.1002/ejhf.1404. Epub 2019 Jan 30.
- Derived from this study: PubMed 30646130Pellikka PA, She L, Holly TA, Lin G, Varadarajan P, Pai RG, Bonow RO, Pohost GM, Panza JA, Berman DS, Prior DL, Asch FM, Borges-Neto S, Grayburn P, Al-Khalidi HR, Miszalski-Jamka K, Desvigne-Nickens P, Lee KL, Velazquez EJ, Oh JK. Variability in Ejection Fraction Measured By Echocardiography, Gated Single-Photon Emission Computed Tomography, and Cardiac Magnetic Resonance in Patients With Coronary Artery Disease and Left Ventricular Dysfunction. JAMA Netw Open. 2018 Aug 3;1(4):e181456. doi: 10.1001/jamanetworkopen.2018.1456.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Bonow principal investigator
Radionuclide Core Lab, Northwestern University
Arthur Feldman principal investigator
Neurohormonal Core Lab, Jefferson University
Eric Velazquez, MD principal investigator
Clinical Coordinating Center, Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CABG surgery plus MED, Active Medication Alone and CABG plus MED and SVR in people with Cardiovascular Diseases and Coronary Disease, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
H01: All Cause Mortality (time frame: 5 years post randomization). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00023595, which also lists 36 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2019.