Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT06399705

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

Led by Weill Medical College of Cornell University · Updated on 2025-10-01

600

Participants Needed

18

Research Sites

743 weeks

Total Duration

On this page

Sponsors

W

Weill Medical College of Cornell University

Lead Sponsor

P

Patient-Centered Outcomes Research Institute

Collaborating Sponsor

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient must identify as a minority
  • Patient is at least 18 years old
  • Multivessel or left main coronary artery disease present with treatment equipoise between CABG and PCI as determined by the local Heart Team
  • Ability to provide written informed consent and comply with follow-up including quality of life questionnaires
Not Eligible

You will not qualify if you...

  • ST-segment elevation myocardial infarction within 3 days
  • Cardiogenic shock
  • Prior PCI within 1 year or any prior CABG at any time
  • Planned hybrid revascularization (PCI after CABG or CABG after PCI)
  • Planned single vessel revascularization except isolated left main disease
  • Need for other cardiac surgery or intervention now or anticipated within 3 years
  • Pregnancy or intent to become pregnant within 1 year after randomization
  • Unable to tolerate or comply with dual antiplatelet therapy for required durations
  • Current participation in another investigational drug or device study not completed
  • Life expectancy less than 3 years due to other non-cardiac conditions
  • Any condition likely to interfere with study procedures or follow-up, such as mental disability, substance abuse, or anticipated relocation

AI-Screening

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Trial Site Locations

Total: 18 locations

1

Adventist Health Glendale

Glendale, California, United States, 91206

Actively Recruiting

2

Emory University

Atlanta, Georgia, United States, 30322

Actively Recruiting

3

Ascension St. Vincent Cardiovascular Research Institute

Carmel, Indiana, United States, 46290

Actively Recruiting

4

Baptist Health Lexington

Lexington, Kentucky, United States, 40503

Actively Recruiting

5

Baptist Health Louisville

Louisville, Kentucky, United States, 40207

Actively Recruiting

6

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Actively Recruiting

7

Englewood Hospital

Englewood, New Jersey, United States, 07631

Actively Recruiting

8

NewYork-Presbyterian Hospital - Queens

Flushing, New York, United States, 11355

Actively Recruiting

9

Icahn School of Medicine - Mount Sinai Morningside

New York, New York, United States, 10025

Actively Recruiting

10

Icahn School of Medicine - Mount Sinai Hospital

New York, New York, United States, 10029

Actively Recruiting

11

Columbia University Irving Medical Center/NewYork-Presbyterian Hospital

New York, New York, United States, 10032

Actively Recruiting

12

Weill Cornell Medicine/NewYork-Presbyterian Hospital

New York, New York, United States, 10065

Actively Recruiting

13

Westchester Medical Center

Valhalla, New York, United States, 10595

Actively Recruiting

14

Duke University

Durham, North Carolina, United States, 27710

Actively Recruiting

15

Ohio State University

Columbus, Ohio, United States, 43210

Actively Recruiting

16

Methodist Le Bonheur Healthcare

Memphis, Tennessee, United States, 38104

Actively Recruiting

17

Ascension Saint Thomas Hospital

Nashville, Tennessee, United States, 37205

Actively Recruiting

18

Baylor Scott and White

Dallas, Texas, United States, 75246

Actively Recruiting

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Research Team

M

Mario Gaudino, MD, PhD, MSCE, FEBCTS, FACC

CONTACT

G

Gregg Stone, MD, FACC, MSCAI

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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