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

Last updated: October 30, 2024
Sponsor: Weill Medical College of Cornell University
Overall Status: Active - Recruiting

Phase

3

Condition

Coronary Artery Disease

Cardiovascular Disease

Thrombosis

Treatment

Coronary artery bypass grafting

Percutaneous coronary intervention

Clinical Study ID

NCT06399705
23-11026800 - 2
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 andfor which there is equipoise between CABG and PCI according to local Heart Teamassessment.

  4. Ability to provide written informed consent and comply with all follow-upprocedures, including QOL questionnaires.

Exclusion

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 coronaryrevascularization at the present time or anticipated within 3 years

  7. Pregnancy (women of child-bearing potential must have a negative pregnancy testwithin 1 week before randomization) or intent to become pregnant within 1 year afterrandomization Unable to tolerate, obtain or comply with dual antiplatelet therapyfor at least 3 months if presentation with stable CAD or 6 months if presentationwith a troponin-positive acute coronary syndrome Current participation in anotherinvestigational drug or device study that has not reached its primary endpointLife-expectancy less than 3 years due to concomitant non-cardiac conditions Anycondition(s) are present that are likely to interfere with the study protocolprocedures including medication adherence and follow-up through 10 years (e.g.mental disability, substance abuse, anticipated international relocation, etc.)

Study Design

Total Participants: 600
Treatment Group(s): 2
Primary Treatment: Coronary artery bypass grafting
Phase: 3
Study Start date:
October 02, 2024
Estimated Completion Date:
January 01, 2039

Study 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.

Connect with a study center

  • Emory University

    Atlanta, Georgia 30322
    United States

    Active - Recruiting

  • Ascension St. Vincent Cardiovascular Research Institute

    Carmel, Indiana 46290
    United States

    Active - Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • Englewood Hospital

    Englewood, New Jersey 07631
    United States

    Active - Recruiting

  • NewYork-Presbyterian Hospital - Queens

    Flushing, New York 11355
    United States

    Active - Recruiting

  • Columbia University Irving Medical Center/NewYork-Presbyterian Hospital

    New York, New York 10032
    United States

    Active - Recruiting

  • Icahn School of Medicine - Mount Sinai Hospital

    New York, New York 10029
    United States

    Active - Recruiting

  • Icahn School of Medicine - Mount Sinai Morningside

    New York, New York 10025
    United States

    Active - Recruiting

  • Weill Cornell Medicine/NewYork-Presbyterian Hospital

    New York, New York 10065
    United States

    Active - Recruiting

  • Westchester Medical Center

    Valhalla, New York 10595
    United States

    Active - Recruiting

  • Duke University

    Durham, North Carolina 27710
    United States

    Active - Recruiting

  • Ohio State University

    Columbus, Ohio 43210
    United States

    Active - Recruiting

  • Methodist Le Bonheur Healthcare

    Memphis, Tennessee 38104
    United States

    Active - Recruiting

  • Ascension Saint Thomas Hospital

    Nashville, Tennessee 37205
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.