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New treatment option for Coronary Artery Disease
Official title REvascularization CHoices Among Under-Represented Groups Evaluation: The RECHARGE Trial - Women
ClinicalTrials.gov ID: NCT06399692
What this study is testing
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Female sex
- Patient is at least 18 years old.
- Multivessel or left main CAD is present for which revascularization is intended and for which there is equipoise between CABG and PCI according to...
- Ability to provide written informed consent and comply with all follow-up procedures, including QOL questionnaires.
You likely can't join if
- ST-segment elevation MI within 3 days
- Cardiogenic shock
- Prior PCI within 1 year or any prior CABG anytime
- Planned hybrid revascularization (PCI after CABG or CABG after PCI)
- Planned single vessel revascularization (other than isolated left main disease)
- Need for any cardiac surgical or treatment procedure other than coronary revascularization at the present time or anticipated within 3 years
See the full eligibility criteria
- Female sex
- Patient is at least 18 years old.
- 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.
- Ability to provide written informed consent and comply with all follow-up procedures, including QOL questionnaires.
- ST-segment elevation MI within 3 days
- Cardiogenic shock
- Prior PCI within 1 year or any prior CABG anytime
- Planned hybrid revascularization (PCI after CABG or CABG after PCI)
- Planned single vessel revascularization (other than isolated left main disease)
- Need for any cardiac surgical or treatment procedure other than coronary revascularization at the present time or anticipated within 3 years
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Glendale, California, United States
- Atlanta, Georgia, United States
- Carmel, Indiana, United States
- Lexington, Kentucky, United States
- Louisville, Kentucky, United States
- Boston, Massachusetts, United States
- Englewood, New Jersey, United States
- Flushing, New York, United States
- New York, New York, United States
- Valhalla, New York, United States
- Durham, North Carolina, United States
- Columbus, Ohio, United States
- Memphis, Tennessee, United States
- Nashville, Tennessee, United States
- Dallas, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Glendale, California, United States; Atlanta, Georgia, United States; Carmel, Indiana, United States; Lexington, Kentucky, United States; Louisville, Kentucky, United States; Boston, Massachusetts, United States and 9 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.