Heart DiseaseNCT00573027
Heart Disease of the Small Arteries in Women and Men
A study testing noninvasive tests in people with Heart Disease, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial summary
Women suffer disproportionately than men from Cardiac Syndrome X ( chest pain in the absence of flow limiting coronary artery stenosis). Coronary microvascular disease is hypothesized to mediate chest pain in this syndrome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Disease
- What is being tested?
- noninvasive tests
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 634 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2005to Jan 2040
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women and men with signs and symptoms of myocardial ischemia and angina or angina equivalent (chest pain, abnormal stress testing, abnormal noninvasive testing) or microvascular angina (MVA) which is defined as angina and ischemic ECG changes without organic obstructive stenosis or epicardial spasm of the coronary arteries
- No obstructive coronary artery disease performed within the previous 24 months (<50% luminal obstruction in one or more coronary arteries on angiography).
- Age > 18 years old
- Competent to give informed consent
Who cannot join
- Obstructive CAD ≥ 50% luminal diameter stenosis in ≥ 1 epicardial coronary artery,
- Acute coronary syndrome (defined by the ACC/AHA criteria, Braunwald 2000),
- Primary valvular heart disease clearly indicating the need for valve repair or replacement;
- Patients with concurrent cardiogenic shock or requiring inotropic or intra-aortic balloon support;
- Prior or planned percutaneous coronary intervention or CABG or prior acute MI in prior 30 days;
- Prior non-cardiac illness with an estimated life expectancy <4 years;
Show all 13Show fewer
- Unable to give informed consent;
- Chest pain with a non-ischemic etiology (e.g.,pericarditis, pneumonia, esophageal spasm);
- Contraindications to adenosine or Regadenoson (Lexiscan)
- Women and men with intermediate coronary stenoses (>20% but <50% luminal diameter stenosis assessed visually at the time of angiography) will undergo clinically indicated IVUS testing based on the judgment of the operator; those determined to have flow FFR or obstructing stenosis will be excluded from the overall study.
- Heart failure (NYHA Class III or IV on treatment)
- LV dysfunction (ejection fraction <40%)
- Documented obstructive myocardiopathy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Barbra Streisand Women's Heart Center contact
United States1 site, 1 recruiting
- Recruiting
Cedars-Sinai Women's Heart Center
Los Angeles, California, 90048
Barbra Streisand Women's Heart Center, 310-423-9666
Noel Bairey-Merz, MD
About this study
Official title: Coronary Microvascular Disease and Endothelial Function in Women and Men
Women suffer disproportionately than men from Cardiac Syndrome X ( chest pain in the absence of flow limiting coronary artery stenosis). Coronary microvascular disease is hypothesized to mediate chest pain in this syndrome. This disorder of the small heart vessels (arterioles) compared to the large vessels (arteries) is not diagnosed during routine heart catheterization. This results in delays in diagnosis, missed opportunities for treatment, and likely contributes to the increased death rate from coronary heart disease in women compared to men.
Current testing for small vessel disease is performed in the cardiac catheterization laboratory using specialized testing and is not performed routinely. Accordingly, women with this condition are either falsely reassured, or misdiagnosed as another non-cardiac condition. Unnecessary healthcare costs related to re-hospitalization and repeat angiography are incurred, while women are often not initiated on appropriate lifesaving treatment. We and others have demonstrated in randomized controlled trials that therapies that target the endothelium, e.g. statins, ACE inhibitors, and exercise are effective in this condition.
Majority of women with Cardiac Syndorme X go undiagnosed. Recent studies have shown significant increased health care costs, morbidity and mortality related to this disease. It is becoming more important to further characterize this group of patients and we hope to do that with our study.
Read the detailed description
Study Aims:
- To establish prevalence of microvascular disease in women and men with Cardiac Syndrome X
- To study the predictive value and utility of noninvasive tests like Peripheral Artery Tonometry (PAT) and Cardiac Magnetic Resonance (CMR) in diagnosing Cardiac Syndrome X.
- To establish prognosis in women and men with Cardiac Syndrome X.
- To elucidate the risk factors, clinical features, diagnostic methods, treatment, and prognosis of patients with microvascular angina (MVA).
With this research study, we want to specifically study a group of patients who have chest pain or other signs or symptoms suggestive of heart disease but don't have visible blockages in the large heart arteries. Patients with chest pain who undergo heart catheterization but have no blockages of large heart arteries will be consented and enrolled. Patients will be asked to fill out questionnaires about their medical history, including family, reproductive and, social histories. They will also be asked to undergo testing during heart catheterization that would test for abnormalities in their small heart arteries using medications, acetylcholine and adenosine. This testing is a standard of care procedure given at the discretion of the treating physician. Patients would receive this test whether they participate in the research or not. The test is performed by infusing acetylcholine and adenosine through the same catheter that is used for routine heart catheterization. This test may add an additional 15 minutes to the heart catheterization procedure.
In addition, patients will be asked to undergo a non-invasive test called Peripheral Arterial Tonometry or PAT for research purposes and in some cases, if clinically indicated a Cardiac Magnetic Resonance (CMR) imaging test as a standard of care. Patients will be followed up using phone questionnaires at 6 months and than annually thereafter. It is proposed that problems with the function of the large and small arteries may be responsible for giving some patients their symptoms of chest pain and put them at risk for heart attacks. PAT may help us more easily and non-invasively measure this function by testing the arteries in the arm. Selected patients will also undergo CMR imaging that may be useful to detect abnormalities in the inner layer of the heart muscle resulting from the abnormal function of the large and small heart arteries. These non-invasive tests will be corroborated with results from invasive testing during heart catheterization, which is considered the gold standard for testing for function of the large and the small heart arteries.
The three tests (heart catheterization with adenosine coronary flow reserve testing, acetylcholine provocative vasomotor testing during heart catheterization, cardiac MRI) are performed for standard care.
Blood and urine collection have been added to this protocol as a secondary outcome for future tests and for testing whether impaired Endothelial Progenitor Cell (EPC) number is related to the presence and severity of microvascular disease.
Results from our study will help confirm the need to test patients with chest pain and open large arteries during heart catheterizations for abnormalities in the function of the large and small heart arteries, and to validate the usefulness of using non-invasive techniques like PAT and CMR for detecting this problem. The study will also help confirm the increased risk of heart attack associated with the abnormal function in the large and small arteries in these patients.
Subjects will be asked if they are interested in receiving information on Pro00015124 (repository/collection). If they are interested, they will be consented under Pro00015124. No specimens collected as part of this study will be forwarded to Pro00015124.
- Conditions
- Heart Disease
- Being tested
- noninvasive tests
- Keywords
- microvascular dysfunction, Microvascular
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
noninvasive testsProcedure or surgery
clinically indicated coronary angiography with adenosine coronary flow reserve measurement and acetylcholine provocative testing in the cardiac catheterization laboratory; Peripheral Artery Tonometry (PAT) testing; Cardiac Magnetic Resonance (CMR) imaging.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Other | 1. fill out baseline demographic and health/medical history questionnaires, CV risk factors, reasons of diagnosis of ischemia, information of coronary artery, and medication use
2. undergo clinically indicated coronary angiography with adenosine coronary flow reserve measurement and acetylcholine provocative testing in the cardiac catheterization laboratory (Appendix);
3. undergo noninvasive Peripheral Artery Tonometry (PAT) testing (Appendix);
4. undergo clinically indicated Cardiac Magnetic Resonance (CMR) imaging (Appendix) to detect subendocardial ischemia (if indicated and referred by the treating physician). The three tests (heart catheterization with adenosine coronary flow reserve testing, acetylcholine provocative vasomotor testing during heart catheterization, cardiac MRI) are performed for standard care.
5. have blood and urine testing.
6. fill out health questionnaires
7. be followed prospectively 6-week, 6-month, and annually for clinical status Receives: Procedure: noninvasive tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
noninvasive Peripheral Artery Tonometry (PAT) testing and Cardiac Magnetic Resonance (CMR) imaging for the outcome of coronary endothelial dysfunction
Measured: 120 minutes
Secondary outcomes (1)
clinically indicated coronary angiography with adenosine coronary flow reserve measurement and acetylcholine provocative testing
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2007 (estimated)
- Study startNov 2005
- Primary completionJan 2040 (estimated)
- Study completionJan 2040 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 634 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noel Bairey Merz, Cedars-Sinai Medical Center
- Investigators
- C.Noel Bairey-Merz, MD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00573027
- Sponsor's protocol ID
- IRB 8221
- Status last verified
- Aug 2023
- First submitted
- 12 Dec 2007
- Last updated
- 1 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coronary Microvascular Disease and Endothelial Function in Women and Men
- ClinicalTrials.gov ID
- NCT00573027
- Acronym / sponsor ID
- IRB 8221
- Conditions
- Heart Disease
- Keywords
- microvascular dysfunction, Microvascular
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 634 participants (estimated)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- Nov 2005
- Primary completion
- Jan 2040 (estimated)
- Study completion
- Jan 2040 (estimated)
- First posted
- 13 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Women suffer disproportionately than men from Cardiac Syndrome X ( chest pain in the absence of flow limiting coronary artery stenosis). Coronary microvascular disease is hypothesized to mediate chest pain in this syndrome. This disorder of the small heart vessels (arterioles) compared to the large vessels (arteries) is not diagnosed during routine heart catheterization. This results in delays in diagnosis, missed opportunities for treatment, and likely contributes to the increased death rate from coronary heart disease in women compared to men.
Current testing for small vessel disease is performed in the cardiac catheterization laboratory using specialized testing and is not performed routinely. Accordingly, women with this condition are either falsely reassured, or misdiagnosed as another non-cardiac condition. Unnecessary healthcare costs related to re-hospitalization and repeat angiography are incurred, while women are often not initiated on appropriate lifesaving treatment. We and others have demonstrated in randomized controlled trials that therapies that target the endothelium, e.g. statins, ACE inhibitors, and exercise are effective in this condition.
Majority of women with Cardiac Syndorme X go undiagnosed. Recent studies have shown significant increased health care costs, morbidity and mortality related to this disease. It is becoming more important to further characterize this group of patients and we hope to do that with our study.
Detailed description
Study Aims:
- To establish prevalence of microvascular disease in women and men with Cardiac Syndrome X
- To study the predictive value and utility of noninvasive tests like Peripheral Artery Tonometry (PAT) and Cardiac Magnetic Resonance (CMR) in diagnosing Cardiac Syndrome X.
- To establish prognosis in women and men with Cardiac Syndrome X.
- To elucidate the risk factors, clinical features, diagnostic methods, treatment, and prognosis of patients with microvascular angina (MVA).
With this research study, we want to specifically study a group of patients who have chest pain or other signs or symptoms suggestive of heart disease but don't have visible blockages in the large heart arteries. Patients with chest pain who undergo heart catheterization but have no blockages of large heart arteries will be consented and enrolled. Patients will be asked to fill out questionnaires about their medical history, including family, reproductive and, social histories. They will also be asked to undergo testing during heart catheterization that would test for abnormalities in their small heart arteries using medications, acetylcholine and adenosine. This testing is a standard of care procedure given at the discretion of the treating physician. Patients would receive this test whether they participate in the research or not. The test is performed by infusing acetylcholine and adenosine through the same catheter that is used for routine heart catheterization. This test may add an additional 15 minutes to the heart catheterization procedure.
In addition, patients will be asked to undergo a non-invasive test called Peripheral Arterial Tonometry or PAT for research purposes and in some cases, if clinically indicated a Cardiac Magnetic Resonance (CMR) imaging test as a standard of care. Patients will be followed up using phone questionnaires at 6 months and than annually thereafter. It is proposed that problems with the function of the large and small arteries may be responsible for giving some patients their symptoms of chest pain and put them at risk for heart attacks. PAT may help us more easily and non-invasively measure this function by testing the arteries in the arm. Selected patients will also undergo CMR imaging that may be useful to detect abnormalities in the inner layer of the heart muscle resulting from the abnormal function of the large and small heart arteries. These non-invasive tests will be corroborated with results from invasive testing during heart catheterization, which is considered the gold standard for testing for function of the large and the small heart arteries.
The three tests (heart catheterization with adenosine coronary flow reserve testing, acetylcholine provocative vasomotor testing during heart catheterization, cardiac MRI) are performed for standard care.
Blood and urine collection have been added to this protocol as a secondary outcome for future tests and for testing whether impaired Endothelial Progenitor Cell (EPC) number is related to the presence and severity of microvascular disease.
Results from our study will help confirm the need to test patients with chest pain and open large arteries during heart catheterizations for abnormalities in the function of the large and small heart arteries, and to validate the usefulness of using non-invasive techniques like PAT and CMR for detecting this problem. The study will also help confirm the increased risk of heart attack associated with the abnormal function in the large and small arteries in these patients.
Subjects will be asked if they are interested in receiving information on Pro00015124 (repository/collection). If they are interested, they will be consented under Pro00015124. No specimens collected as part of this study will be forwarded to Pro00015124.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Other | Procedure: noninvasive tests1. fill out baseline demographic and health/medical history questionnaires, CV risk factors, reasons of diagnosis of ischemia, information of coronary artery, and medication use 2. undergo clinically indicated coronary angiography with adenosine coronary flow reserve measurement and acetylcholine provocative testing in the cardiac catheterization laboratory (Appendix); 3. undergo noninvasive Peripheral Artery Tonometry (PAT) testing (Appendix); 4. undergo clinically indicated Cardiac Magnetic Resonance (CMR) imaging (Appendix) to detect subendocardial ischemia (if indicated and referred by the treating physician). The three tests (heart catheterization with adenosine coronary flow reserve testing, acetylcholine provocative vasomotor testing during heart catheterization, cardiac MRI) are performed for standard care. 5. have blood and urine testing. 6. fill out health questionnaires 7. be followed prospectively 6-week, 6-month, and annually for clinical status |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Women and men with signs and symptoms of myocardial ischemia and angina or angina equivalent (chest pain, abnormal stress testing, abnormal noninvasive testing) or microvascular angina (MVA) which is defined as angina and ischemic ECG changes without organic obstructive stenosis or epicardial spasm of the coronary arteries
- No obstructive coronary artery disease performed within the previous 24 months (<50% luminal obstruction in one or more coronary arteries on angiography).
- Age > 18 years old
- Competent to give informed consent
Key exclusion criteria (13 listed)
- Obstructive CAD ≥ 50% luminal diameter stenosis in ≥ 1 epicardial coronary artery,
- Acute coronary syndrome (defined by the ACC/AHA criteria, Braunwald 2000),
- Primary valvular heart disease clearly indicating the need for valve repair or replacement;
- Patients with concurrent cardiogenic shock or requiring inotropic or intra-aortic balloon support;
- Prior or planned percutaneous coronary intervention or CABG or prior acute MI in prior 30 days;
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 |
|---|---|---|
| noninvasive testsclinically indicated coronary angiography with adenosine coronary flow reserve measurement and acetylcholine provocative testing in the cardiac catheterization laboratory; Peripheral Artery Tonometry (PAT) testing; Cardiac Magnetic Resonance (CMR) imaging. | Procedure or surgery | Single Arm |
Primary outcome
noninvasive Peripheral Artery Tonometry (PAT) testing and Cardiac Magnetic Resonance (CMR) imaging for the outcome of coronary endothelial dysfunction
Time frame: 120 minutes
1 secondary outcome
clinically indicated coronary angiography with adenosine coronary flow reserve measurement and acetylcholine provocative testing
Time frame: 60 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2023.
- Individual participant dataSharing planned: No
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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.
Barbra Streisand Women's Heart Center contact
C.Noel Bairey-Merz, MD principal investigator
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing noninvasive tests in people with Heart Disease, run by Cedars-Sinai Medical Center 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 4 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 1 Sep 2023. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Barbra Streisand Women's Heart Center (310-423-9666), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
noninvasive Peripheral Artery Tonometry (PAT) testing and Cardiac Magnetic Resonance (CMR) imaging for the outcome of coronary endothelial dysfunction (time frame: 120 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Sep 2023.