NOT_YET_RECRUITING
REvascularization CHoices Among Under-Represented Groups Evaluation: The RECHARGE Trial - Women
This is a research study in women 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
🗓️ Study Start (Actual) 1 July 2024
🗓️ Primary Completion (Estimated) 15 March 2033
✅ Study Completion (Estimated) 1 January 2039
👥 Enrollment (Estimated) 600
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE3
Locations:
📍 New York, New York, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • 1. Female sex
    • 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
    • 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.)
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ 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

  • First Submitted 30 April 2024
  • First Submitted that Met QC Criteria 30 April 2024
  • First Posted 6 May 2024

Study Record Updates

  • Last Update Submitted that Met QC Criteria 25 June 2024
  • Last Update Posted 26 June 2024
  • Last Verified June 2024