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

Heart Procedures Study for Minority Groups

S
Sara Pereira

Primary Investigator

Enrolling By Invitation
18 years or above
All
Phase 3
600 participants needed
1 Location

Brief description of study

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.

THIS STUDY IS ENROLLING BY INVITATION ONLY

Detailed description of study

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.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Coronary Artery Disease, CAD
  • Age: 18 years or above
  • Gender: All

Inclusion Criteria:

  1. Patient must identify as a minority
  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 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.)

This study investigates two different procedures to restore blood flow to the heart in minority groups. The purpose of this study is to compare outcomes between a procedure where blockages are opened with a balloon and stented, and an open-heart surgery where healthy blood vessels are used to bypass blockages. These procedures are important for people with heart artery blockages, and the study will look at survival and quality of life after the treatments.

Participants will undergo a procedure where they either receive a stent or have bypass surgery. A stent is a small wire mesh tube that keeps the artery open. In bypass surgery, doctors use healthy vessels from other parts of the body to go around the blocked arteries. Participants will have follow-up visits and tests, including echocardiograms and blood tests, to check their heart health.

  • Who can participate: Adults 18 and older who identify as a minority and have specific heart artery disease can join. They must consent and follow study procedures; those with recent heart attacks or certain conditions cannot.
  • Study details: Participants will receive a stent or bypass surgery, with recovery monitored through follow-ups. Follow-ups include calls and tests to check heart health.
Updated on 08 Jul 2026. Study ID: SURG-WEILL-RECHARGE, 23-11026800 - 2, 29419
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Interested in the study?

This study is accepting only persons who receive care at a certain clinic or doctor or who are part of an invited group. Questions about this study can be directed to the study team listed in the description or contact your doctor to see if you are eligible.

Accepting Referrals by Invitation Only