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

Weill Cornell Medicine (WCM)

Status and phase

Enrolling

Phase 3

Conditions

Coronary Artery Disease

Treatments

Procedure: Coronary artery bypass grafting

Procedure: Percutaneous coronary intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT06399705

23-11026800 - 2

Details and patient eligibility

About

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.

Full 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.

Enrollment

600 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.)