Ischemic CardiomyopathyIABP-HRNCT03857906
Evaluation of Prophylactic Use of a Preoperative IABP in High-Risk Coronary Artery Bypass Graft Surgery
An observational study of Ischemic Cardiomyopathy and Heart Failure, run by CMN "20 de Noviembre".
Trial summary
Background: The intra-aortic balloon balloon pump (IABP) has been used as a method of percutaneous circulatory assistance high surgical risk patients undergoing coronary artery bypass graft surgery (CABG); Although its applicability has been questioned by clinical trials showing poor impact to reduce the mortality due… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Ischemic Cardiomyopathy, Heart Failure
- What is being tested?
- Intra-Aortic Ballon Pump insertion
- Type of treatment
- Medical device
- How many people
- 129 participants
- Where
- No sites listed yet
- Study dates
- 21 Oct 2014to 19 Jan 2019
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
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 99 years
- All sexes
- Adult, Older adult
Study population: Patients scheduled for cardiac surgery were assessed for the inclusion/exclusion criteria, provided signed informed consent, and were allocated to one of two treatments: IABP insertion before skin incision (IABP group) or no IABP insertion (control group). In all cases, the decision of the IABP insertion was generated in a previous Heart Team session, this team was integrated by a Clinical Cardiologist, Cardiac Interventionist, Cardiothoracic Surgeon and Anesthesiologist, in base on the personal risk/benefit of each patient. There was no blinding for patients or physicians in aware of the Heart Team decisions. Outcome assessors were unaware of the assigned treatment.
Who may be able to join
- All patients greater than 18 years
- Scheduled for coronary artery bypass graft (CABG) surgery were eligible
- Multiple vessel disease with or without left main coronary artery (LMCA) significant stenosis (>50%)
- Written informed consent provided
Who cannot join
- Prior cardiogenic shock,
- Acute myocardial infarction (AMI) less than 48 hours prior to enrollment
- Previous IABP use
- AMI mechanical complications
- Aortic regurgitation greater than grade II in severity (on a scale of I to IV, with higher grades indicating more severe regurgitation)
- Tachyarrhythmia
Show all 12Show fewer
- Other aortic procedures
- Other non-CABG surgical procedures
- Massive pulmonary embolism
- Older than 90 years of age
- Any coagulopathy
- Severe concomitant disease associated with a life expectancy of less than 6 months.
About this study
Official title: Evaluation of Prophylactic Use of a Preoperative Intra-Aortic Ballon Pump in High-Risk Coronary Artery Bypass Graft Surgery: A Single-Centre Study
Background: The intra-aortic balloon balloon pump (IABP) has been used as a method of percutaneous circulatory assistance high surgical risk patients undergoing coronary artery bypass graft surgery (CABG); Although its applicability has been questioned by clinical trials showing poor impact to reduce the mortality due to cardiogenic shock associated with postoperative acute myocardial infarction (AMI), the real benefit reducing mortality in the postoperative context (PO) has not been determined examined through a prospective study with an adequate design.
Objective: To compare PO complications such as mortality, perioperative infarction and other complications in patients with high surgical risk undergoing CABG in comparison with controls.
Read the detailed description
Methods: Quasi-experimental, prospective, comparative, non-randomized study. The decision to place the BIAC is not part of the study and depends on the multidisciplinary decision of a Heart Team, based on the individualized risk / benefit. The study population consists on high surgical risk patients with atherosclerotic coronary disease undergoing CABG in our centre between 2014-2018. Patients are excluded if any condition is present: cardiogenic shock, with AMI 48 hours prior and / or severe aortic insufficiency. In one group BIAC will be inserted 1-6 hours before surgery (BIAC group) and a second group is control (non-BIAC group). A minimum 30-day postoperative follow-up of will be performed, with primary end points (mortality and AMI type V) and secondary end points (additional PO complications).
Analysis: An evaluation of normality distribution K-S will be performed, the means of quantitative (t-Test) and categorical variables (Fisher or χ² Pearson) will be compared. A multivariate analysis will be performed with linear logistic regression to evaluate the influence of age, sex, peripheral arterial disease (PAD) and EuroSCORE-II on the primary goal. Statistical significance will be considered when p <0.05. Softwares: GraphPad-Prism-5.0 and SPSS-15.0
- Conditions
- Ischemic Cardiomyopathy, Heart Failure
- Being tested
- Intra-Aortic Ballon Pump insertion
- Keywords
- intra-aortic balloon pump, coronary artery bypass graft, preoperative
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra-Aortic Ballon Pump insertionDevice
The IABP (Ultraflex IAB 7.5F, 2.5mm; Arrow International, Reading, PA) was inserted percutaneously through the right femoral artery in the previous 1 - 6 hours before the scheduled surgery. Positioning of the IABP was guided by radioscopy. The balloon size was based on the patient's height (30, 40 or 50 cc). Transesophageal echocardiography was used to confirm correct IABP placement before and after CABG
| Study group | Role | What they receive |
|---|---|---|
| IABP group | Over 18 years With ischemic heart disease Multivessel disease with/without LMCA involvement High-risk coronary disease Intra-Aortic Ballon Pump insertion 1-6 hours prior to surgery Receives: Device: Intra-Aortic Ballon Pump insertion | |
| No-IABP group | Over 18 years With ischemic heart disease Multivessel disease with/without LMCA involvement High-risk coronary disease No IABP |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-Day All-Cause Mortality
30-Day Mortality
Measured: 30 days
30-Day Postoperative Myocardial Infarction
Based on the third universal definition on MI criteria
Measured: 30 days
Secondary outcomes (6)
30-day occurrence rate of PCI
30-day occurrence rate of emergent percutaneous coronary intervention
Measured: 30 days
Requirement of mechanical ventilation
Requirement of mechanical ventilation for longer than 24 hours
Measured: 30 days
acute kidney injury
AKIN classification
Measured: 30 days
Need for renal replacement therapy
Need for RRT (hemodialysis, peritoneal)
Measured: 30 days
ICU length of stay
ICU and in-hospital length of stay
Measured: 30 days
Postoperative use of inotropes and vasopressors
Postoperative use of inotropes and vasopressors
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2019
- Study start21 Oct 2014
- Primary completion21 Feb 2018
- Study completion19 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic CardiomyopathyStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 129 participants (actual)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- CMN "20 de Noviembre"
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado
- Responsible party
- Principal investigator, Héctor Hugo Escutia Cuevas, CMN "20 de Noviembre"
- Investigators
- Juán Antonio Suárez-Cuenca, Principal investigator, CMN "20 de Noviembre"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03857906
- Sponsor's protocol ID
- 2018
- Acronym
- IABP-HR
- Status last verified
- Mar 2019
- First submitted
- 23 Feb 2019
- Last updated
- 6 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Prophylactic Use of a Preoperative Intra-Aortic Ballon Pump in High-Risk Coronary Artery Bypass Graft Surgery: A Single-Centre Study
- ClinicalTrials.gov ID
- NCT03857906
- Acronym / sponsor ID
- IABP-HR / 2018
- Conditions
- Ischemic Cardiomyopathy, Heart Failure
- Keywords
- intra-aortic balloon pump, coronary artery bypass graft, preoperative
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- CMN "20 de Noviembre"University, hospital or other
- Collaborators
- Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado
- Study start
- 21 Oct 2014 (actual)
- Primary completion
- 21 Feb 2018 (actual)
- Study completion
- 19 Jan 2019 (actual)
- First posted
- 28 Feb 2019 (actual)
- 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.
Background: The intra-aortic balloon balloon pump (IABP) has been used as a method of percutaneous circulatory assistance high surgical risk patients undergoing coronary artery bypass graft surgery (CABG); Although its applicability has been questioned by clinical trials showing poor impact to reduce the mortality due to cardiogenic shock associated with postoperative acute myocardial infarction (AMI), the real benefit reducing mortality in the postoperative context (PO) has not been determined examined through a prospective study with an adequate design.
Objective: To compare PO complications such as mortality, perioperative infarction and other complications in patients with high surgical risk undergoing CABG in comparison with controls.
Detailed description
Methods: Quasi-experimental, prospective, comparative, non-randomized study. The decision to place the BIAC is not part of the study and depends on the multidisciplinary decision of a Heart Team, based on the individualized risk / benefit. The study population consists on high surgical risk patients with atherosclerotic coronary disease undergoing CABG in our centre between 2014-2018. Patients are excluded if any condition is present: cardiogenic shock, with AMI 48 hours prior and / or severe aortic insufficiency. In one group BIAC will be inserted 1-6 hours before surgery (BIAC group) and a second group is control (non-BIAC group). A minimum 30-day postoperative follow-up of will be performed, with primary end points (mortality and AMI type V) and secondary end points (additional PO complications).
Analysis: An evaluation of normality distribution K-S will be performed, the means of quantitative (t-Test) and categorical variables (Fisher or χ² Pearson) will be compared. A multivariate analysis will be performed with linear logistic regression to evaluate the influence of age, sex, peripheral arterial disease (PAD) and EuroSCORE-II on the primary goal. Statistical significance will be considered when p <0.05. Softwares: GraphPad-Prism-5.0 and SPSS-15.0
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IABP group | – | Device: Intra-Aortic Ballon Pump insertionOver 18 years With ischemic heart disease Multivessel disease with/without LMCA involvement High-risk coronary disease Intra-Aortic Ballon Pump insertion 1-6 hours prior to surgery |
| No-IABP group | – | –Over 18 years With ischemic heart disease Multivessel disease with/without LMCA involvement High-risk coronary disease No IABP |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for cardiac surgery were assessed for the inclusion/exclusion criteria, provided signed informed consent, and were allocated to one of two treatments: IABP insertion before skin incision (IABP group) or no IABP insertion (control group). In all cases, the decision of the IABP insertion was generated in a previous Heart Team session, this team was integrated by a Clinical Cardiologist, Cardiac Interventionist, Cardiothoracic Surgeon and Anesthesiologist, in base on the personal risk/benefit of each patient. There was no blinding for patients or physicians in aware of the Heart Team decisions. Outcome assessors were unaware of the assigned treatment.
Key inclusion criteria (4 listed)
- All patients greater than 18 years
- Scheduled for coronary artery bypass graft (CABG) surgery were eligible
- Multiple vessel disease with or without left main coronary artery (LMCA) significant stenosis (>50%)
- Written informed consent provided
Key exclusion criteria (12 listed)
- Prior cardiogenic shock,
- Acute myocardial infarction (AMI) less than 48 hours prior to enrollment
- Previous IABP use
- AMI mechanical complications
- Aortic regurgitation greater than grade II in severity (on a scale of I to IV, with higher grades indicating more severe regurgitation)
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 |
|---|---|---|
| Intra-Aortic Ballon Pump insertionThe IABP (Ultraflex IAB 7.5F, 2.5mm; Arrow International, Reading, PA) was inserted percutaneously through the right femoral artery in the previous 1 - 6 hours before the scheduled surgery. Positioning of the IABP was guided by radioscopy. The balloon size was based on the patient's height (30, 40 or 50 cc). Transesophageal echocardiography was used to confirm correct IABP placement before and after CABG | Device | IABP group |
Primary outcome
30-Day All-Cause Mortality
Time frame: 30 days
30-Day Mortality
30-Day Postoperative Myocardial Infarction
Time frame: 30 days
Based on the third universal definition on MI criteria
6 secondary outcomes
30-day occurrence rate of PCI
Time frame: 30 days
Requirement of mechanical ventilation
Time frame: 30 days
acute kidney injury
Time frame: 30 days
Need for renal replacement therapy
Time frame: 30 days
ICU length of stay
Time frame: 30 days
Postoperative use of inotropes and vasopressors
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2019.
Related trials for Ischemic Cardiomyopathy
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Recruiting
Positron Emission Tomography to Assess the Effect of Camzyos on Ischaemia in HOCM: PEACH Trial
Hypertrophic Obstructive Cardiomyopathy \(HOCM\), Left Ventricular Outflow Tract Obstruction
Recruiting
A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter
Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation
RecruitingObservational study
A 10-Minute Cardiovascular Magnetic Resonance Protocol for Cardiac Disease
Coronary Artery Disease, Myocarditis
Not yet recruitingObservational study
PAtient Similarity for Decision-Making in Prevention of Cardiovascular Toxicity (PACT): A Feasibility Study
Heart Failure, Coronary Artery Disease
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.
Juán Antonio Suárez-Cuenca principal investigator
CMN "20 de Noviembre"
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Cardiomyopathy and Heart Failure, run by CMN "20 de Noviembre".
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 12 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 6 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
30-Day All-Cause Mortality (time frame: 30 days). The study lists 2 primary outcomes in all. 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 6 Mar 2019.