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Procedure

Revascularization Procedures for Coronary Artery Disease (RECHARGE:M Trial)

Phase 3
Recruiting
Led By Gregg Stone, MD, FACC, MSCAI
Research Sponsored by Weill Medical College of Cornell University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient is at least 18 years old.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
Pivotal Trial
No Placebo-Only Group

Summary

This trial aims to compare two procedures that restore blood flow to the heart's arteries in minority populations. One procedure involves using a small wire mesh tube to clear blockages, while the other involves a more

Who is the study for?
The RECHARGE trial is for minority individuals at least 18 years old with multivessel or left main coronary artery disease (CAD), where a heart team believes both stenting and bypass surgery could work. Participants must be able to give consent and complete quality-of-life questionnaires.
What is being tested?
This study compares two heart procedures in minorities: one uses stents to open blockages via an incision in the wrist or groin, while the other is open-heart surgery using vessels from elsewhere in the body to bypass blockages.
What are the potential side effects?
Stenting may cause bleeding, blood vessel damage, or irregular heartbeats. Bypass surgery risks include infection, stroke, kidney problems, and sometimes memory issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Hierarchical composite of all-cause death and time-averaged change from baseline in generic quality of life using the SF-12v2
Secondary study objectives
Time averaged change from baseline in disease-specific quality of life using the SAQ-OS
Other study objectives
Time-averaged changes in EQ5D-VAS Scores
Time-averaged changes in MoCA scores
Time-averaged changes in PHQ Scores
+1 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: RECHARGE: Minorities - PCIExperimental Treatment1 Intervention
Group II: RECHARGE: Minorities - CABGExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Coronary artery bypass grafting
2003
Completed Phase 4
~490
Percutaneous coronary intervention
2011
Completed Phase 4
~25990

Find a Location

Who is running the clinical trial?

Weill Medical College of Cornell UniversityLead Sponsor
1,087 Previous Clinical Trials
1,148,147 Total Patients Enrolled
15 Trials studying Coronary Artery Disease
47,843 Patients Enrolled for Coronary Artery Disease
Patient-Centered Outcomes Research InstituteOTHER
574 Previous Clinical Trials
27,078,359 Total Patients Enrolled
2 Trials studying Coronary Artery Disease
1,116 Patients Enrolled for Coronary Artery Disease
Icahn School of Medicine at Mount SinaiOTHER
904 Previous Clinical Trials
541,221 Total Patients Enrolled
26 Trials studying Coronary Artery Disease
31,220 Patients Enrolled for Coronary Artery Disease
~400 spots leftby Mar 2033
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