RECRUITING

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

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Conditions

Coronary Artery DiseaseRECHARGECardiac SurgeryMinoritypercutaneous coronary interventionQuality of Life

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-10-02
Study Completion:2039-01-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06399705

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Patient must identify as a minority
  2. 2. Patient is at least 18 years old.
  3. 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. 4. Ability to provide written informed consent and comply with all follow-up procedures, including QOL questionnaires.
  1. 1. ST-segment elevation MI within 3 days
  2. 2. Cardiogenic shock
  3. 3. Prior PCI within 1 year or any prior CABG anytime
  4. 4. Planned hybrid revascularization (PCI after CABG or CABG after PCI)
  5. 5. Planned single vessel revascularization (other than isolated left main disease)
  6. 6. Need for any cardiac surgical or interventional procedure other than coronary revascularization at the present time or anticipated within 3 years
  7. 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.)

Contacts and Locations

Study Contact

Mario Gaudino, MD, PhD, MSCE, FEBCTS, FACC
CONTACT
Gregg.Stone@mountsinai.org
mfg9004@med.cornell.edu
Gregg Stone, MD, FACC, MSCAI
CONTACT
Gregg.Stone@mountsinai.org

Principal Investigator

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 Locations (Sites)

Emory University
Atlanta, Georgia, 30322
United States
Ascension St. Vincent Cardiovascular Research Institute
Carmel, Indiana, 46290
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
Englewood Hospital
Englewood, New Jersey, 07631
United States
NewYork-Presbyterian Hospital - Queens
Flushing, New York, 11355
United States
Icahn School of Medicine - Mount Sinai Morningside
New York, New York, 10025
United States
Icahn School of Medicine - Mount Sinai Hospital
New York, New York, 10029
United States
Columbia University Irving Medical Center/NewYork-Presbyterian Hospital
New York, New York, 10032
United States
Weill Cornell Medicine/NewYork-Presbyterian Hospital
New York, New York, 10065
United States
Westchester Medical Center
Valhalla, New York, 10595
United States
Duke University
Durham, North Carolina, 27710
United States
Ohio State University
Columbus, Ohio, 43210
United States
Methodist Le Bonheur Healthcare
Memphis, Tennessee, 38104
United States
Ascension Saint Thomas Hospital
Nashville, Tennessee, 37205
United States

Collaborators and Investigators

Sponsor: 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-02
Study Completion Date2039-01-01

Study Record Updates

Study Start Date2024-10-02
Study Completion Date2039-01-01

Terms related to this study

Keywords Provided by Researchers

  • RECHARGE
  • Cardiac Surgery
  • Minority
  • percutaneous coronary intervention
  • Quality of Life

Additional Relevant MeSH Terms

  • Coronary Artery Disease