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

Description

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.

Conditions

Coronary Artery Disease

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Coronary Artery Disease
Intervention / Treatment

-

Contacts and Locations

Atlanta

Emory University, Atlanta, Georgia, United States, 30322

Carmel

Ascension St. Vincent Cardiovascular Research Institute, Carmel, Indiana, United States, 46290

Boston

Massachusetts General Hospital, Boston, Massachusetts, United States, 02114

Englewood

Englewood Hospital, Englewood, New Jersey, United States, 07631

Flushing

NewYork-Presbyterian Hospital - Queens, Flushing, New York, United States, 11355

New York

Icahn School of Medicine - Mount Sinai Morningside, New York, New York, United States, 10025

New York

Icahn School of Medicine - Mount Sinai Hospital, New York, New York, United States, 10029

New York

Columbia University Irving Medical Center/NewYork-Presbyterian Hospital, New York, New York, United States, 10032

New York

Weill Cornell Medicine/NewYork-Presbyterian Hospital, New York, New York, United States, 10065

Valhalla

Westchester Medical Center, Valhalla, New York, United States, 10595

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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.)

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Weill Medical College of Cornell University,

Mario Gaudino, MD, PhD, MSCE, FEBCTS, FACC, PRINCIPAL_INVESTIGATOR, Weill Medical College of Cornell University

Gregg Stone, MD, FACC, MSCAI, PRINCIPAL_INVESTIGATOR, Icahn School of Medicine at Mount Sinai

Study Record Dates

2039-01-01