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NCT06399692PHASE3Recruiting

REvascularization CHoices Among Under-Represented Groups Evaluation: The RECHARGE Trial - Women

Weill Medical College of Cornell University

Start Date

9/16/2024

Completion Date

1/1/2039

Summary

This is a research study in women 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.

Detailed Description

The RECHARGE: Women 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.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: 1. Female sex 2. Patient is at least 18 years old. 3. 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. 4. Ability to provide written informed consent and comply with all follow-up procedures, including QOL questionnaires. Exclusion Criteria: 1. ST-segment elevation MI within 3 days 2. Cardiogenic shock 3. Prior PCI within 1 year or any prior CABG anytime 4. Planned hybrid revascularization (PCI after CABG or CABG after PCI) 5. Planned single vessel revascularization (other than isolated left main disease) 6. Need for any cardiac surgical or interventional procedure other than coronary revascularization at the present time or anticipated within 3 years 7. 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 8. 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 9. Current participation in another investigational drug or device study that has not reached its primary endpoint 10. Life-expectancy less than 3 years due to concomitant non-cardiac conditions 11. 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.)

Interventions

PROCEDURE

Coronary artery bypass grafting (CABG)

PROCEDURE

Percutaneous coronary intervention (PCI)

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Conditions

Coronary Artery Disease

Locations

Adventist Health Glendale

Glendale, California 91206

United States

Emory University

Atlanta, Georgia 30322

United States

Ascension St. Vincent Cardiovascular Research Institute

Carmel, Indiana 46290

United States

Baptist Health Lexington

Lexington, Kentucky 40503

United States

Baptist Health Louisville

Louisville, Kentucky 40207

United States

Massachusetts General Hospital

Boston, Massachusetts 02114

United States

Englewood Hospital

Englewood, New Jersey 07631

United States

NewYork-Presbyterian Hospital - Queens

Flushing, New York 11355

United States

Icahn School of Medicine - Mount Sinai Morningside

New York, New York 10025

United States

Icahn School of Medicine - Mount Sinai Hospital

New York, New York 10029

United States

Columbia University Irving Medical Center/NewYork-Presbyterian Hospital

New York, New York 10032

United States

Weill Cornell Medicine / NYPH

New York, New York 10065

United States

Westchester Medical Center

Valhalla, New York 10595

United States

Duke University

Durham, North Carolina 27710

United States

Ohio State University

Columbus, Ohio 43210

United States

Methodist Le Bonheur Healthcare

Memphis, Tennessee 38104

United States

Ascension Saint Thomas Hospital

Nashville, Tennessee 37205

United States

Baylor Scott and White

Dallas, Texas 75246

United States