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

RecruitingPhase 3

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
Inclusion Criteria:

1. Patient must identify as Black race or Hispanic ethnicity
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, with the exception that surgical or interventional left atrial appendage ligation or occlusion and/or atrial fibrillation ablation may be performed at site discretion either during or subsequent to the index revascularization procedure
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.)

About the 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.

What is being tested

Sponsor: Weill Medical College of Cornell University · Participants: 600 · Started: Oct 2, 2024

Contact the study team

Official record on ClinicalTrials.gov — NCT06399705

Locations in the U.S.

CaliforniaAdventist Health Glendale, Glendale
GeorgiaEmory University, Atlanta
IndianaAscension St. Vincent Cardiovascular Research Institute, Carmel
KentuckyBaptist Health Lexington, Lexington
Baptist Health Louisville, Louisville
MassachusettsMassachusetts General Hospital, Boston
New JerseyEnglewood Hospital, Englewood
New YorkNewYork-Presbyterian Hospital - Queens, Flushing
Columbia University Irving Medical Center/NewYork-Presbyterian Hospital, New York
Icahn School of Medicine - Mount Sinai Hospital, New York
Icahn School of Medicine - Mount Sinai Morningside, New York
Weill Cornell Medicine/NewYork-Presbyterian Hospital, New York
Westchester Medical Center, Valhalla
North CarolinaDuke University, Durham
OhioOhio State University, Columbus
TennesseeMethodist Le Bonheur Healthcare, Memphis
Ascension Saint Thomas Hospital, Nashville
TexasBaylor Scott and White, Dallas

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.