REvascularization CHoices Among Under-Represented Groups Evaluation: The RECHARGE Trial - Minorities (RECHARGE:M)

September 29, 2025 updated by: Weill Medical College of Cornell University

This is a research study in minorities to compare the outcomes of two procedures that restore blood flow to the arteries of the heart. In one procedure the blockages are ballooned and then stented with a small wire mesh tube through a small incision in the wrist or the groin. The other procedure is an open-heart operation in which healthy blood vessels from inside the chest, leg, and/or forearm are used to "bypass" the blockages (like a detour). Outcomes will be measured by comparing survival and improvement in quality-of-life.

Study Overview

Status

Recruiting

Conditions

Coronary Artery Disease

Intervention / Treatment

Detailed Description

The RECHARGE: Minorities Trial is a multicenter, 1:1 randomized, open-label superiority trial.

Patients meeting the eligibility criteria for whom there is equipoise for revascularization with CABG and PCI, as determined by the local Heart Team, will be included. Participants will be followed for 5-10 years. Telephone follow-up will be conducted by the a central follow-up coordinating center at 30 days, 3 months, 6 months, and thereafter every 6 months through 36 months post-randomization. After 36 months, follow-up will be performed every year (48, 60, 72, 84, 96, 108, 120 months). A repeat transthoracic echocardiogram and blood draw for serum creatinine, hemoglobin and lipids should be performed at 1 year, as per standard of care, at either an out-patient facility or in a hospital.

Study Type

Interventional

Enrollment (Estimated)

600

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Gregg Stone, MD, FACC, MSCAI
Email: Gregg.Stone@mountsinai.org

Study Contact Backup

Name: Mario Gaudino, MD, PhD, MSCE, FEBCTS, FACC
Phone Number: Gregg.Stone@mountsinai.org
Email: mfg9004@med.cornell.edu

Study Locations

United States
- California
  - Glendale, California, United States, 91206
    - Recruiting
    - Adventist Health Glendale
- Georgia
  - Atlanta, Georgia, United States, 30322
    - Recruiting
    - Emory University
- Indiana
  - Carmel, Indiana, United States, 46290
    - Recruiting
    - Ascension St. Vincent Cardiovascular Research Institute
- Kentucky
  - Lexington, Kentucky, United States, 40503
    - Recruiting
    - Baptist Health Lexington
  - Louisville, Kentucky, United States, 40207
    - Recruiting
    - Baptist Health Louisville
- Massachusetts
  - Boston, Massachusetts, United States, 02114
    - Recruiting
    - Massachusetts General Hospital
- New Jersey
  - Englewood, New Jersey, United States, 07631
    - Recruiting
    - Englewood Hospital
- New York
  - Flushing, New York, United States, 11355
    - Recruiting
    - NewYork-Presbyterian Hospital - Queens
  - New York, New York, United States, 10029
    - Recruiting
    - Icahn School of Medicine - Mount Sinai Hospital
  - New York, New York, United States, 10065
    - Recruiting
    - Weill Cornell Medicine/NewYork-Presbyterian Hospital
  - New York, New York, United States, 10025
    - Recruiting
    - Icahn School of Medicine - Mount Sinai Morningside
  - New York, New York, United States, 10032
    - Recruiting
    - Columbia University Irving Medical Center/NewYork-Presbyterian Hospital
  - Valhalla, New York, United States, 10595
    - Recruiting
    - Westchester Medical Center
- North Carolina
  - Durham, North Carolina, United States, 27710
    - Recruiting
    - Duke University
- Ohio
  - Columbus, Ohio, United States, 43210
    - Recruiting
    - Ohio State University
- Tennessee
  - Memphis, Tennessee, United States, 38104
    - Recruiting
    - Methodist Le Bonheur Healthcare
  - Nashville, Tennessee, United States, 37205
    - Recruiting
    - Ascension Saint Thomas Hospital
- Texas
  - Dallas, Texas, United States, 75246
    - Recruiting
    - Baylor Scott and White

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Description

Inclusion Criteria:

Patient must identify as a minority
Patient is at least 18 years old.
Multivessel or left main CAD is present for which revascularization is intended and for which there is equipoise between CABG and PCI according to local Heart Team assessment.
Ability to provide written informed consent and comply with all follow-up procedures, including QOL questionnaires.

Exclusion Criteria:

ST-segment elevation MI within 3 days
Cardiogenic shock
Prior PCI within 1 year or any prior CABG anytime
Planned hybrid revascularization (PCI after CABG or CABG after PCI)
Planned single vessel revascularization (other than isolated left main disease)
Need for any cardiac surgical or interventional procedure other than coronary revascularization at the present time or anticipated within 3 years
Pregnancy (women of child-bearing potential must have a negative pregnancy test within 1 week before randomization) or intent to become pregnant within 1 year after randomization Unable to tolerate, obtain or comply with dual antiplatelet therapy for at least 3 months if presentation with stable CAD or 6 months if presentation with a troponin-positive acute coronary syndrome Current participation in another investigational drug or device study that has not reached its primary endpoint Life-expectancy less than 3 years due to concomitant non-cardiac conditions Any condition(s) are present that are likely to interfere with the study protocol procedures including medication adherence and follow-up through 10 years (e.g. mental disability, substance abuse, anticipated international relocation, etc.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Single

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: RECHARGE: Minorities - CABG	Procedure: Coronary artery bypass grafting Coronary artery bypass grafting (CABG), also called heart bypass surgery, is a medical procedure to improve blood flow to the heart. Other Names: CABG
Other: RECHARGE: Minorities - PCI	Procedure: Percutaneous coronary intervention Percutaneous coronary intervention (PCI) is a non-surgical procedure used to treat the blockages in a coronary artery; it opens up narrowed or blocked sections of the artery, restoring blood flow to the heart Other Names: PCI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hierarchical composite of all-cause death and time-averaged change from baseline in generic quality of life using the SF-12v2 Time Frame: 5 years	Generic quality of life (QOL) will be assessed by utilizing the 12-item Short Form Survey (SF-12v2). The score ranges from 1-100, with higher scores indicating a better health status. The win ratio will be used	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time averaged change from baseline in disease-specific quality of life using the SAQ-OS Time Frame: 5 years	Disease-specific quality of life (QOL) will be assessed by utilizing the Seattle Angina Questionnaire overall summary (SAQ-OS) score. The score ranges from 1-100, with higher scores indicating a better health status.	5 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time-averaged changes in PROMIS-29 Scores Time Frame: 1 month, 3months, 6months, 12months and annually after procedure	The PROMIS-29 instrument measures pain intensity on a scale of 0-10 plus 7 health domains: pain interference, fatigue, sleep disturbance, depressive symptoms, anxiety, physical function, and ability to participate in social roles. Each of the 7 domains is scored separately, with the lowest score for an individual domain being 4 and the highest being 20. Pain intensity is scored on the scale from 1-10. A mean of 50 and a standard deviation of 10 represent the general US population. A T-score rescales the raw scores to standardized scores. For most measures, higher T-scores indicate more of the concept being measured, except for physical function, which is reverse-scored (lower scores indicate worse function).	1 month, 3months, 6months, 12months and annually after procedure
Time-averaged changes in EQ5D-VAS Scores Time Frame: 1 month, 3months, 6months, 12months and annually after procedure	The EQ5D-VAS records self-rated health status on a graduated visual analog scale (VAS) from 0-100, with higher scores for higher health-related quality of life. It also includes the EQ-5D descriptive system, which comprises 5 dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.	1 month, 3months, 6months, 12months and annually after procedure
Time-averaged changes in PHQ Scores Time Frame: 1 month, 3months, 6months, 12months and annually after procedure	The Patient Health Questionnaire (PHQ-8) is an 8-item questionnaire used to diagnose and quantify the severity of depressive symptoms. It is designed to evaluate the overall QOL of the individual and questions are based on the diagnostic criteria for Major Depressive Disorder outlined in the Diagnostic and Statistical Manual, 5th Edition (DSM-5). The lowest score is 0 and the highest score is 24. Scores ≥10 suggest a substantial burden of depressive symptoms.	1 month, 3months, 6months, 12months and annually after procedure
Time-averaged changes in MoCA scores Time Frame: 1 month, 3months, 6months, 12months and annually after procedure	The telephone Montreal Cognitive Assessment (MoCA Blind or T-MoCA) is a tool to assess mild cognitive impairment. The MoCA BlindT-MoCA consists of 15 non-visual items that assesses different cognitive domains, including attention and concentration, memory, language, conceptual thinking, calculations, and orientation. The maximum score is 22 points with a score of 18 or below signifying mild cognitive dysfunction.	1 month, 3months, 6months, 12months and annually after procedure
Number of days alive and out of hospital after procedure Time Frame: up to 5 years after procedure		up to 5 years after procedure
Time to death Time Frame: 1 month after procedure		1 month after procedure
Time to death Time Frame: 3 months after procedure		3 months after procedure
Time to death Time Frame: 6 months after procedure		6 months after procedure
Time to death Time Frame: 12 months after procedure		12 months after procedure
Time to death Time Frame: 18 months after procedure		18 months after procedure
Time to death Time Frame: 24 months after procedure		24 months after procedure
Time to death Time Frame: 30 months after procedure		30 months after procedure
Time to death Time Frame: 36 months after procedure		36 months after procedure
Time to death Time Frame: 48 months after procedure		48 months after procedure
Time to death Time Frame: 60 months after procedure		60 months after procedure
Time to death Time Frame: 72 months after procedure		72 months after procedure
Time to death Time Frame: 84 months after procedure		84 months after procedure
Time to death Time Frame: 96 months after procedure		96 months after procedure
Time to death Time Frame: 108 months after procedure		108 months after procedure
Time to death Time Frame: 120 months after procedure		120 months after procedure
Time to cardiovascular death Time Frame: 1 month after procedure		1 month after procedure
Time to cardiovascular death Time Frame: 3 months after procedure		3 months after procedure
Time to cardiovascular death Time Frame: 6 months after procedure		6 months after procedure
Time to cardiovascular death Time Frame: 12 months after procedure		12 months after procedure
Time to cardiovascular death Time Frame: 18 months after procedure		18 months after procedure
Time to cardiovascular death Time Frame: 24 months after procedure		24 months after procedure
Time to cardiovascular death Time Frame: 36 months after procedure		36 months after procedure
Time to cardiovascular death Time Frame: 48 months after procedure		48 months after procedure
Time to cardiovascular death Time Frame: 60 months after procedure		60 months after procedure
Time to cardiovascular death Time Frame: 72 months after procedure		72 months after procedure
Time to cardiovascular death Time Frame: 84 months after procedure		84 months after procedure
Time to cardiovascular death Time Frame: 96 months after procedure		96 months after procedure
Time to cardiovascular death Time Frame: 108 months after procedure		108 months after procedure
Time to cardiovascular death Time Frame: 120 months after procedure		120 months after procedure
Time to non-cardiovascular death Time Frame: 1 month after procedure		1 month after procedure
Time to non-cardiovascular death Time Frame: 3 months after procedure		3 months after procedure
Time to non-cardiovascular death Time Frame: 6 months after procedure		6 months after procedure
Time to non-cardiovascular death Time Frame: 12 months after procedure		12 months after procedure
Time to non-cardiovascular death Time Frame: 18 months after procedure		18 months after procedure
Time to non-cardiovascular death Time Frame: 24 months after procedure		24 months after procedure
Time to non-cardiovascular death Time Frame: 30 months after procedure		30 months after procedure
Time to non-cardiovascular death Time Frame: 36 months after procedure		36 months after procedure
Time to non-cardiovascular death Time Frame: 48 months after procedure		48 months after procedure
Time to non-cardiovascular death Time Frame: 60 months after procedure		60 months after procedure
Time to non-cardiovascular death Time Frame: 72 months after procedure		72 months after procedure
Time to non-cardiovascular death Time Frame: 84 months after procedure		84 months after procedure
Time to non-cardiovascular death Time Frame: 96 months after procedure		96 months after procedure
Time to non-cardiovascular death Time Frame: 108 months after procedure		108 months after procedure
Time to non-cardiovascular death Time Frame: 120 months after procedure		120 months after procedure
Time to myocardial infarction Time Frame: 1 month after procedure		1 month after procedure
Time to myocardial infarction Time Frame: 3 months after procedure		3 months after procedure
Time to myocardial infarction Time Frame: 6 months after procedure		6 months after procedure
Time to myocardial infarction Time Frame: 12 months after procedure		12 months after procedure
Time to myocardial infarction Time Frame: 18 months after procedure		18 months after procedure
Time to myocardial infarction Time Frame: 24 months after procedure		24 months after procedure
Time to myocardial infarction Time Frame: 30 months after procedure		30 months after procedure
Time to myocardial infarction Time Frame: 36 months after procedure		36 months after procedure
Time to myocardial infarction Time Frame: 48 months after procedure		48 months after procedure
Time to myocardial infarction Time Frame: 60 months after procedure		60 months after procedure
Time to myocardial infarction Time Frame: 72 months after procedure		72 months after procedure
Time to myocardial infarction Time Frame: 84 months after procedure		84 months after procedure
Time to myocardial infarction Time Frame: 96 months after procedure		96 months after procedure
Time to myocardial infarction Time Frame: 108 months after procedure		108 months after procedure
Time to myocardial infarction Time Frame: 120 months after procedure		120 months after procedure
Time to stroke/transient ischemic attack Time Frame: 1 month after procedure		1 month after procedure
Time to stroke/transient ischemic attack Time Frame: 3 months after procedure		3 months after procedure
Time to stroke/transient ischemic attack Time Frame: 6 months after procedure		6 months after procedure
Time to stroke/transient ischemic attack Time Frame: 12 months after procedure		12 months after procedure
Time to stroke/transient ischemic attack Time Frame: 18 months after procedure		18 months after procedure
Time to stroke/transient ischemic attack Time Frame: 24 months after procedure		24 months after procedure
Time to stroke/transient ischemic attack Time Frame: 30 months after procedure		30 months after procedure
Time to stroke/transient ischemic attack Time Frame: 36 months after procedure		36 months after procedure
Time to stroke/transient ischemic attack Time Frame: 48 months after procedure		48 months after procedure
Time to stroke/transient ischemic attack Time Frame: 60 months after procedure		60 months after procedure
Time to stroke/transient ischemic attack Time Frame: 72 months after procedure		72 months after procedure
Time to stroke/transient ischemic attack Time Frame: 84 months after procedure		84 months after procedure
Time to stroke/transient ischemic attack Time Frame: 96 months after procedure		96 months after procedure
Time to stroke/transient ischemic attack Time Frame: 108 months after procedure		108 months after procedure
Time to stroke/transient ischemic attack Time Frame: 120 months after procedure		120 months after procedure
Time to hospitalization Time Frame: 1 month after procedure		1 month after procedure
Time to hospitalization Time Frame: 3 months after procedure		3 months after procedure
Time to hospitalization Time Frame: 6 months after procedure		6 months after procedure
Time to hospitalization Time Frame: 12 months after procedure		12 months after procedure
Time to hospitalization Time Frame: 18 months after procedure		18 months after procedure
Time to hospitalization Time Frame: 24 months after procedure		24 months after procedure
Time to hospitalization Time Frame: 30 months after procedure		30 months after procedure
Time to hospitalization Time Frame: 36 months after procedure		36 months after procedure
Time to hospitalization Time Frame: 48 months after procedure		48 months after procedure
Time to hospitalization Time Frame: 60 months after procedure		60 months after procedure
Time to hospitalization Time Frame: 72 months after procedure		72 months after procedure
Time to hospitalization Time Frame: 84 months after procedure		84 months after procedure
Time to hospitalization Time Frame: 96 months after procedure		96 months after procedure
Time to hospitalization Time Frame: 108 months after procedure		108 months after procedure
Time to hospitalization Time Frame: 120 months after procedure		120 months after procedure
Time to unplanned revascularization Time Frame: 1 month after procedure		1 month after procedure
Time to unplanned revascularization Time Frame: 3 months after procedure		3 months after procedure
Time to unplanned revascularization Time Frame: 6 months after procedure		6 months after procedure
Time to unplanned revascularization Time Frame: 12 months after procedure		12 months after procedure
Time to unplanned revascularization Time Frame: 18 months after procedure		18 months after procedure
Time to unplanned revascularization Time Frame: 24 months after procedure		24 months after procedure
Time to unplanned revascularization Time Frame: 30 months after procedure		30 months after procedure
Time to unplanned revascularization Time Frame: 36 months after procedure		36 months after procedure
Time to unplanned revascularization Time Frame: 48 months after procedure		48 months after procedure
Time to unplanned revascularization Time Frame: 60 months after procedure		60 months after procedure
Time to unplanned revascularization Time Frame: 72 months after procedure		72 months after procedure
Time to unplanned revascularization Time Frame: 84 months after procedure		84 months after procedure
Time to unplanned revascularization Time Frame: 96 months after procedure		96 months after procedure
Time to unplanned revascularization Time Frame: 108 months after procedure		108 months after procedure
Time to unplanned revascularization Time Frame: 120 months after procedure		120 months after procedure
Time to atrial fibrillation/ atrial flutter Time Frame: 1 month after procedure		1 month after procedure
Time to atrial fibrillation/ atrial flutter Time Frame: 3 months after procedure		3 months after procedure
Time to atrial fibrillation/ atrial flutter Time Frame: 6 months after procedure		6 months after procedure
Time to atrial fibrillation/ atrial flutter Time Frame: 12 months after procedure		12 months after procedure
Time to atrial fibrillation/ atrial flutter Time Frame: 18 months after procedure		18 months after procedure
Time to atrial fibrillation/ atrial flutter Time Frame: 24 months after procedure		24 months after procedure
Time to atrial fibrillation/ atrial flutter Time Frame: 30 months after procedure		30 months after procedure
Time to atrial fibrillation/ atrial flutter Time Frame: 36 months after procedure		36 months after procedure
Time to atrial fibrillation/ atrial flutter Time Frame: 48 months after procedure		48 months after procedure
Time to atrial fibrillation/ atrial flutter Time Frame: 60 months after procedure		60 months after procedure
Time to atrial fibrillation/ atrial flutter Time Frame: 72 months after procedure		72 months after procedure
Time to atrial fibrillation/ atrial flutter Time Frame: 84 months after procedure		84 months after procedure
Time to atrial fibrillation/ atrial flutter Time Frame: 96 months after procedure		96 months after procedure
Time to atrial fibrillation/ atrial flutter Time Frame: 108 months after procedure		108 months after procedure
Time to atrial fibrillation/ atrial flutter Time Frame: 120 months after procedure		120 months after procedure
Time to ventricular tachycardia/ventricular fibrillation Time Frame: 1 month after procedure		1 month after procedure
Time to ventricular tachycardia/ventricular fibrillation Time Frame: 3 months after procedure		3 months after procedure
Time to ventricular tachycardia/ventricular fibrillation Time Frame: 6 months after procedure		6 months after procedure
Time to ventricular tachycardia/ventricular fibrillation Time Frame: 12 months after procedure		12 months after procedure
Time to ventricular tachycardia/ventricular fibrillation Time Frame: 18 months after procedure		18 months after procedure
Time to ventricular tachycardia/ventricular fibrillation Time Frame: 24 months after procedure		24 months after procedure
Time to ventricular tachycardia/ventricular fibrillation Time Frame: 30 months after procedure		30 months after procedure
Time to ventricular tachycardia/ventricular fibrillation Time Frame: 36 months after procedure		36 months after procedure
Time to ventricular tachycardia/ventricular fibrillation Time Frame: 48 months after procedure		48 months after procedure
Time to ventricular tachycardia/ventricular fibrillation Time Frame: 60 months after procedure		60 months after procedure
Time to ventricular tachycardia/ventricular fibrillation Time Frame: 72 months after procedure		72 months after procedure
Time to ventricular tachycardia/ventricular fibrillation Time Frame: 84 months after procedure		84 months after procedure
Time to ventricular tachycardia/ventricular fibrillation Time Frame: 96 months after procedure		96 months after procedure
Time to ventricular tachycardia/ventricular fibrillation Time Frame: 108 months after procedure		108 months after procedure
Time to ventricular tachycardia/ventricular fibrillation Time Frame: 120 months after procedure		120 months after procedure
Time to heart block Time Frame: 1 month after procedure		1 month after procedure
Time to heart block Time Frame: 3 months after procedure		3 months after procedure
Time to heart block Time Frame: 6 months after procedure		6 months after procedure
Time to heart block Time Frame: 12 months after procedure		12 months after procedure
Time to heart block Time Frame: 18 months after procedure		18 months after procedure
Time to heart block Time Frame: 24 months after procedure		24 months after procedure
Time to heart block Time Frame: 30 months after procedure		30 months after procedure
Time to heart block Time Frame: 36 months after procedure		36 months after procedure
Time to heart block Time Frame: 48 months after procedure		48 months after procedure
Time to heart block Time Frame: 60 months after procedure		60 months after procedure
Time to heart block Time Frame: 72 months after procedure		72 months after procedure
Time to heart block Time Frame: 84 months after procedure		84 months after procedure
Time to heart block Time Frame: 96 months after procedure		96 months after procedure
Time to heart block Time Frame: 108 months after procedure		108 months after procedure
Time to heart block Time Frame: 120 months after procedure		120 months after procedure
Time to bleeding Time Frame: 1 month after procedure		1 month after procedure
Time to bleeding Time Frame: 3 months after procedure		3 months after procedure
Time to bleeding Time Frame: 6 months after procedure		6 months after procedure
Time to bleeding Time Frame: 12 months after procedure		12 months after procedure
Time to bleeding Time Frame: 18 months after procedure		18 months after procedure
Time to bleeding Time Frame: 24 months after procedure		24 months after procedure
Time to bleeding Time Frame: 30 months after procedure		30 months after procedure
Time to bleeding Time Frame: 36 months after procedure		36 months after procedure
Time to bleeding Time Frame: 48 months after procedure		48 months after procedure
Time to bleeding Time Frame: 60 months after procedure		60 months after procedure
Time to bleeding Time Frame: 72 months after procedure		72 months after procedure
Time to bleeding Time Frame: 84 months after procedure		84 months after procedure
Time to bleeding Time Frame: 96 months after procedure		96 months after procedure
Time to bleeding Time Frame: 108 months after procedure		108 months after procedure
Time to bleeding Time Frame: 120 months after procedure		120 months after procedure
Time to vascular complications Time Frame: 1 month after procedure		1 month after procedure
Time to vascular complications Time Frame: 3 months after procedure		3 months after procedure
Time to vascular complications Time Frame: 6 months after procedure		6 months after procedure
Time to vascular complications Time Frame: 12 months after procedure		12 months after procedure
Time to vascular complications Time Frame: 18 months after procedure		18 months after procedure
Time to vascular complications Time Frame: 24 months after procedure		24 months after procedure
Time to vascular complications Time Frame: 30 months after procedure		30 months after procedure
Time to vascular complications Time Frame: 36 months after procedure		36 months after procedure
Time to vascular complications Time Frame: 48 months after procedure		48 months after procedure
Time to vascular complications Time Frame: 60 months after procedure		60 months after procedure
Time to vascular complications Time Frame: 72 months after procedure		72 months after procedure
Time to vascular complications Time Frame: 84 months after procedure		84 months after procedure
Time to vascular complications Time Frame: 96 months after procedure		96 months after procedure
Time to vascular complications Time Frame: 108 months after procedure		108 months after procedure
Time to vascular complications Time Frame: 120 months after procedure		120 months after procedure
Time to heart failure Time Frame: 1 month after procedure		1 month after procedure
Time to heart failure Time Frame: 3 months after procedure		3 months after procedure
Time to heart failure Time Frame: 6 months after procedure		6 months after procedure
Time to heart failure Time Frame: 12 months after procedure		12 months after procedure
Time to heart failure Time Frame: 18 months after procedure		18 months after procedure
Time to heart failure Time Frame: 24 months after procedure		24 months after procedure
Time to heart failure Time Frame: 30 months after procedure		30 months after procedure
Time to heart failure Time Frame: 36 months after procedure		36 months after procedure
Time to heart failure Time Frame: 48 months after procedure		48 months after procedure
Time to heart failure Time Frame: 60 months after procedure		60 months after procedure
Time to heart failure Time Frame: 72 months after procedure		72 months after procedure
Time to heart failure Time Frame: 84 months after procedure		84 months after procedure
Time to heart failure Time Frame: 96 months after procedure		96 months after procedure
Time to heart failure Time Frame: 108 months after procedure		108 months after procedure
Time to heart failure Time Frame: 120 months after procedure		120 months after procedure
Time to left ventricular assist device/orthotopic heart transplant Time Frame: 1 month after procedure		1 month after procedure
Time to left ventricular assist device/orthotopic heart transplant Time Frame: 3 months after procedure		3 months after procedure
Time to left ventricular assist device/orthotopic heart transplant Time Frame: 6 months after procedure		6 months after procedure
Time to left ventricular assist device/orthotopic heart transplant Time Frame: 12 months after procedure		12 months after procedure
Time to left ventricular assist device/orthotopic heart transplant Time Frame: 18 months after procedure		18 months after procedure
Time to left ventricular assist device/orthotopic heart transplant Time Frame: 24 months after procedure		24 months after procedure
Time to left ventricular assist device/orthotopic heart transplant Time Frame: 30 months after procedure		30 months after procedure
Time to left ventricular assist device/orthotopic heart transplant Time Frame: 36 months after procedure		36 months after procedure
Time to left ventricular assist device/orthotopic heart transplant Time Frame: 48 months after procedure		48 months after procedure
Time to left ventricular assist device/orthotopic heart transplant Time Frame: 60 months after procedure		60 months after procedure
Time to left ventricular assist device/orthotopic heart transplant Time Frame: 72 months after procedure		72 months after procedure
Time to left ventricular assist device/orthotopic heart transplant Time Frame: 84 months after procedure		84 months after procedure
Time to left ventricular assist device/orthotopic heart transplant Time Frame: 96 months after procedure		96 months after procedure
Time to left ventricular assist device/orthotopic heart transplant Time Frame: 108 months after procedure		108 months after procedure
Time to left ventricular assist device/orthotopic heart transplant Time Frame: 120 months after procedure		120 months after procedure
Time to infection Time Frame: 1 month after procedure		1 month after procedure
Time to infection Time Frame: 3 months after procedure		3 months after procedure
Time to infection Time Frame: 6 months after procedure		6 months after procedure
Time to infection Time Frame: 12 months after procedure		12 months after procedure
Time to infection Time Frame: 18 months after procedure		18 months after procedure
Time to infection Time Frame: 24 months after procedure		24 months after procedure
Time to infection Time Frame: 30 months after procedure		30 months after procedure
Time to infection Time Frame: 36 months after procedure		36 months after procedure
Time to infection Time Frame: 48 months after procedure		48 months after procedure
Time to infection Time Frame: 60 months after procedure		60 months after procedure
Time to infection Time Frame: 72 months after procedure		72 months after procedure
Time to infection Time Frame: 84 months after procedure		84 months after procedure
Time to infection Time Frame: 96 months after procedure		96 months after procedure
Time to infection Time Frame: 108 months after procedure		108 months after procedure
Time to infection Time Frame: 120 months after procedure		120 months after procedure
Time to acute kidney injury/chronic kidney disease Time Frame: 1 month after procedure		1 month after procedure
Time to acute kidney injury/chronic kidney disease Time Frame: 3 months after procedure		3 months after procedure
Time to acute kidney injury/chronic kidney disease Time Frame: 6 months after procedure		6 months after procedure
Time to acute kidney injury/chronic kidney disease Time Frame: 12 months after procedure		12 months after procedure
Time to acute kidney injury/chronic kidney disease Time Frame: 18 months after procedure		18 months after procedure
Time to acute kidney injury/chronic kidney disease Time Frame: 24 months after procedure		24 months after procedure
Time to acute kidney injury/chronic kidney disease Time Frame: 30 months after procedure		30 months after procedure
Time to acute kidney injury/chronic kidney disease Time Frame: 36 months after procedure		36 months after procedure
Time to acute kidney injury/chronic kidney disease Time Frame: 48 months after procedure		48 months after procedure
Time to acute kidney injury/chronic kidney disease Time Frame: 60 months after procedure		60 months after procedure
Time to acute kidney injury/chronic kidney disease Time Frame: 72 months after procedure		72 months after procedure
Time to acute kidney injury/chronic kidney disease Time Frame: 84 months after procedure		84 months after procedure
Time to acute kidney injury/chronic kidney disease Time Frame: 96 months after procedure		96 months after procedure
Time to acute kidney injury/chronic kidney disease Time Frame: 108 months after procedure		108 months after procedure
Time to acute kidney injury/chronic kidney disease Time Frame: 120 months after procedure		120 months after procedure
Number of subjects with complete revascularization Time Frame: 30 days after procedure		30 days after procedure
Number of subjects with reasonably complete revascularization Time Frame: 30 days after procedure		30 days after procedure
Change in blood lipids Time Frame: Baseline, 12 months post-procedure		Baseline, 12 months post-procedure
Change in hemoglobin Time Frame: Baseline, 12 months post-procedure		Baseline, 12 months post-procedure
Change in LVEF Time Frame: Baseline, 12 months post-procedure		Baseline, 12 months post-procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Weill Medical College of Cornell University

Collaborators

Patient-Centered Outcomes Research Institute

Icahn School of Medicine at Mount Sinai

Investigators

Principal Investigator: Mario Gaudino, MD, PhD, MSCE, FEBCTS, FACC, Weill Medical College of Cornell University
Principal Investigator: Gregg Stone, MD, FACC, MSCAI, ICAHN School of Medicine at Mount Sinai

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 2, 2024

Primary Completion (Estimated)

March 15, 2033

Study Completion (Estimated)

January 1, 2039

Study Registration Dates

First Submitted

April 30, 2024

First Submitted That Met QC Criteria

April 30, 2024

First Posted (Actual)

May 6, 2024

Study Record Updates

Last Update Posted (Estimated)

October 1, 2025

Last Update Submitted That Met QC Criteria

September 29, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

23-11026800 - 2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

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Clinical Trials on Coronary Artery Disease

Infirmerie Protestante de Lyon

Recruiting

Postural Mobilization Compared to Noradrenaline Only in Off-Pump CABG Surgery (OPTICAB)

Coronary Artery Bypass | Coronary Artery Disease(CAD) | Off Pump Coronary Artery Bypass Surgery | Hemodynamic Optimization | Hemodynamic Management | Off Pump Coronary Artery Bypass Graft | Coronary Artery Disease With Need for Bypass Surgery | Noradrenaline

France
Shanghai Bluesail Boyuan Medical Technology Co....

Not yet recruiting

Lithotripsy Versus Balloon Angioplasty for Optimal Treatment of CAlcified Lesions With and Without Optical Coherence Tomography evaluatION (LOCATION)

Coronary Artery Disease | Coronary Artery Calcification | Severe Coronary Artery Disease

China
Scitech Produtos Medicos SA

Not yet recruiting

Brazilian Prospective Registry of the Inspiron EVO Drug-Eluting Stent in Complex Coronary Lesions (PCI EVOlution)

Coronary Artery Disease (CAD) | Multivessel Coronary Artery Disease | Complex Coronary Lesions | Calcific Coronary Arteriosclerosis | Small Vessel Ischemic Disease | Stenosis Coronary

Brazil
Istanbul Mehmet Akif Ersoy Educational and Training...
Bakirkoy Dr. Sadi Konuk Research and Training Hospital; Ege University; Istanbul... and other collaborators

Active, not recruiting

Crossover vs Accurate Ostial PCI for Medina 0.0.1 and 0.1.0 Left Main Bifurcation Lesions

Coronary Artery Disease (CAD) | Coronary Bifurcation Lesion | Left Main Coronary Artery Stenosis

Turkey (Türkiye)
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

Completed

High Risk Atherosclerosis Identified at Cardiac CT Among Patients With vs Without Family History of CAD

Coronary Artery Disease (CAD) | Atherosclerosis of Coronary Artery

Italy
EBI Anti Sepsis BV
CR2O B.V.

Not yet recruiting

A Clinical Trial To Investigate The Effect Of EA-230 On Hospital Length Of Stay In Patients With Coronary Artery Disease (CAD) Undergoing Coronary Artery Bypass Grafting (CABG) Surgery. (EasyBoost)

Coronary Artery Disease (CAD) | Coronary Artery Bypass Graft Surgery(CABG)

United States, Netherlands, Belgium, United Kingdom
Elixir Medical Corporation
Istituto Clinico Humanitas

Active, not recruiting

DYNAMX Bioadaptor ImplanTation for the trEatment of Complex Coronary Lesions (DYNAMITE)

Coronary Artery Disease | Chronic Total Occlusion of Coronary Artery | Multi Vessel Coronary Artery Disease | Bifurcation of Coronary Artery | Long Lesions Coronary Artery Disease

Italy
University Medical Centre Ljubljana

Recruiting

Resistance Training Added to Aerobic Interval Training to Improve Aerobic Capacity and Muscle Mass in Women With Coronary Artery Disease (VAKAR)

Coronary Artery Disease With Myocardial Infarction

Slovenia
Shunmei Medical

Not yet recruiting

ShockFast Intravascular Lithotripsy Device for Treatment of Calcified Coronary Lesions (IVL)

Calcified Coronary Artery Disease | Coronary Arterial Disease

Poland, France, Spain
OPCI Core Laboratories LLC

Not yet recruiting

AERO CAD Study Evaluating the Shockwave C2 Aero IVL System in Coronary Artery Disease (AERO CAD)

Coronary Artery Disease (CAD) | Coronary Calcification | Coronary Calcified Disease | Coronary Calcified Nodules

United States

Clinical Trials on Coronary artery bypass grafting

University of Oulu
Karolinska Institutet; Universita di Verona; University of Campania "Luigi Vanvitelli... and other collaborators

Recruiting

Outcome After Coronary Artery Bypass Grafting (E-CABG)

Myocardial Infarction | Coronary Artery Disease | Angina Pectoris

Finland
University of Wuerzburg
Deutsche Stiftung für Herzforschung

Unknown

Surgical Manipulation of the Aorta and Cerebral Infarction

Stroke | Coronary Heart Disease | Cerebral Infarction

Germany
Austin Health

Active, not recruiting

Radial Artery Patency and Clinical Outcomes Trial (RAPCO)

Coronary Artery Disease | Atherosclerosis

Australia
Armed Forces Institute of Cardiology, Pakistan

Completed

ICU Stay in Patients With Low Ejection Fraction Undergoing Cardiac Revascularization: Comparison of On-pump vs Off-pump Coronary Artery Bypass Grafting

Cardiac Revascularization

Pakistan
Region Örebro County
Swedish Heart Lung Foundation; Regional Clinical Research

Completed

Evaluation of Graft Material in Coronary Artery Bypass Grafting (CABG)

Angina Pectoris

Sweden
Federal State Budgetary Institution "Federal Center...

Completed

Coronary Revascularization Outcomes Within Necessary Sex and Gender Aspects (CROWN-SAGA)

Coronary Artery Disease | Ischemic Heart Disease | Coronary Artery Bypass Grafting

Russian Federation
Medical University of Silesia

Completed

Impact of Body Weight on Outcomes of Patients Undergoing Coronary Artery Bypass Grafting

Coronary Artery Disease | Obesity | Angina Pectoris | Coronary; Ischemic
University Medical Center Groningen

Unknown

The Influence of Cognitive Decline on Quality of Life After Coronary Bypass

Coronary Artery Bypass | Cognitive Dysfunction

Netherlands
Cliniques universitaires Saint-Luc- Université...

Completed

Comparison Between 2 Bilateral Internal Thoracic Artery Coronary Artery Bypass Grafting Configurations

Coronary Disease

Belgium
Far Eastern Memorial Hospital

Completed

Endoscopic Saphenous Vein Harvest for Coronary Artery Bypass Grafting

Coronary Artery Disease

REvascularization CHoices Among Under-Represented Groups Evaluation: The RECHARGE Trial - Minorities (RECHARGE:M)

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Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

Clinical Trials on Coronary Artery Disease

Clinical Trials on Coronary artery bypass grafting

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