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

Coronary Artery Disease Clinical Trial

— RECHARGE:M  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06399705
• Other study ID #: 23-11026800 - 2
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: May 1, 2024
• Est. completion date: January 1, 2039

Study information

• Verified date: April 2024
• Source: Weill Medical College of Cornell University
• Contact: Mario Gaudino, MD, PhD, MSCE, FEBCTS, FACC
• Phone: Gregg.Stone@mountsinai.org
• Email: mfg9004[@]med.cornell.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

The RECHARGE: Minorities Trial is a multicenter, 1:1 randomized, open-label superiority trial.

Patients meeting the eligibility criteria for whom there is equipoise for revascularization with CABG and PCI, as determined by the local Heart Team, will be included. Participants will be followed for 5-10 years. Telephone follow-up will be conducted by the a central follow-up coordinating center at 30 days, 3 months, 6 months, and thereafter every 6 months through 36 months post-randomization. After 36 months, follow-up will be performed every year (48, 60, 72, 84, 96, 108, 120 months). A repeat transthoracic echocardiogram and blood draw for serum creatinine, hemoglobin and lipids should be performed at 1 year, as per standard of care, at either an out-patient facility or in a hospital.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 600
• Est. completion date: January 1, 2039
• Est. primary completion date: March 15, 2033
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patient must identify as a minority

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 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.)

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Procedure:
• Coronary artery bypass grafting
Coronary artery bypass grafting (CABG), also called heart bypass surgery, is a medical procedure to improve blood flow to the heart.
• Percutaneous coronary intervention
Percutaneous coronary intervention (PCI) is a non-surgical procedure used to treat the blockages in a coronary artery; it opens up narrowed or blocked sections of the artery, restoring blood flow to the heart

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University	Icahn School of Medicine at Mount Sinai, Patient-Centered Outcomes Research Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Time-averaged changes in PROMIS-29 Scores	The PROMIS-29 instrument measures pain intensity on a scale of 0-10 plus 7 health domains: pain interference, fatigue, sleep disturbance, depressive symptoms, anxiety, physical function, and ability to participate in social roles. Each of the 7 domains is scored separately, with the lowest score for an individual domain being 4 and the highest being 20. Pain intensity is scored on the scale from 1-10. A mean of 50 and a standard deviation of 10 represent the general US population. A T-score rescales the raw scores to standardized scores. For most measures, higher T-scores indicate more of the concept being measured, except for physical function, which is reverse-scored (lower scores indicate worse function).	1 month, 3months, 6months, 12months and annually after procedure
Other	Time-averaged changes in EQ5D-VAS Scores	The EQ5D-VAS records self-rated health status on a graduated visual analog scale (VAS) from 0-100, with higher scores for higher health-related quality of life. It also includes the EQ-5D descriptive system, which comprises 5 dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.	1 month, 3months, 6months, 12months and annually after procedure
Other	Time-averaged changes in PHQ Scores	The Patient Health Questionnaire (PHQ-8) is an 8-item questionnaire used to diagnose and quantify the severity of depressive symptoms. It is designed to evaluate the overall QOL of the individual and questions are based on the diagnostic criteria for Major Depressive Disorder outlined in the Diagnostic and Statistical Manual, 5th Edition (DSM-5). The lowest score is 0 and the highest score is 24. Scores =10 suggest a substantial burden of depressive symptoms.	1 month, 3months, 6months, 12months and annually after procedure
Other	Time-averaged changes in MoCA scores	The telephone Montreal Cognitive Assessment (MoCA Blind or T-MoCA) is a tool to assess mild cognitive impairment. The MoCA BlindT-MoCA consists of 15 non-visual items that assesses different cognitive domains, including attention and concentration, memory, language, conceptual thinking, calculations, and orientation. The maximum score is 22 points with a score of 18 or below signifying mild cognitive dysfunction.	1 month, 3months, 6months, 12months and annually after procedure
Other	Number of days alive and out of hospital after procedure		up to 5 years after procedure
Other	Time to death		1 month after procedure
Other	Time to death		3 months after procedure
Other	Time to death		6 months after procedure
Other	Time to death		12 months after procedure
Other	Time to death		18 months after procedure
Other	Time to death		24 months after procedure
Other	Time to death		30 months after procedure
Other	Time to death		36 months after procedure
Other	Time to death		48 months after procedure
Other	Time to death		60 months after procedure
Other	Time to death		72 months after procedure
Other	Time to death		84 months after procedure
Other	Time to death		96 months after procedure
Other	Time to death		108 months after procedure
Other	Time to death		120 months after procedure
Other	Time to cardiovascular death		1 month after procedure
Other	Time to cardiovascular death		3 months after procedure
Other	Time to cardiovascular death		6 months after procedure
Other	Time to cardiovascular death		12 months after procedure
Other	Time to cardiovascular death		18 months after procedure
Other	Time to cardiovascular death		24 months after procedure
Other	Time to cardiovascular death		36 months after procedure
Other	Time to cardiovascular death		48 months after procedure
Other	Time to cardiovascular death		60 months after procedure
Other	Time to cardiovascular death		72 months after procedure
Other	Time to cardiovascular death		84 months after procedure
Other	Time to cardiovascular death		96 months after procedure
Other	Time to cardiovascular death		108 months after procedure
Other	Time to cardiovascular death		120 months after procedure
Other	Time to non-cardiovascular death		1 month after procedure
Other	Time to non-cardiovascular death		3 months after procedure
Other	Time to non-cardiovascular death		6 months after procedure
Other	Time to non-cardiovascular death		12 months after procedure
Other	Time to non-cardiovascular death		18 months after procedure
Other	Time to non-cardiovascular death		24 months after procedure
Other	Time to non-cardiovascular death		30 months after procedure
Other	Time to non-cardiovascular death		36 months after procedure
Other	Time to non-cardiovascular death		48 months after procedure
Other	Time to non-cardiovascular death		60 months after procedure
Other	Time to non-cardiovascular death		72 months after procedure
Other	Time to non-cardiovascular death		84 months after procedure
Other	Time to non-cardiovascular death		96 months after procedure
Other	Time to non-cardiovascular death		108 months after procedure
Other	Time to non-cardiovascular death		120 months after procedure
Other	Time to myocardial infarction		1 month after procedure
Other	Time to myocardial infarction		3 months after procedure
Other	Time to myocardial infarction		6 months after procedure
Other	Time to myocardial infarction		12 months after procedure
Other	Time to myocardial infarction		18 months after procedure
Other	Time to myocardial infarction		24 months after procedure
Other	Time to myocardial infarction		30 months after procedure
Other	Time to myocardial infarction		36 months after procedure
Other	Time to myocardial infarction		48 months after procedure
Other	Time to myocardial infarction		60 months after procedure
Other	Time to myocardial infarction		72 months after procedure
Other	Time to myocardial infarction		84 months after procedure
Other	Time to myocardial infarction		96 months after procedure
Other	Time to myocardial infarction		108 months after procedure
Other	Time to myocardial infarction		120 months after procedure
Other	Time to stroke/transient ischemic attack		1 month after procedure
Other	Time to stroke/transient ischemic attack		3 months after procedure
Other	Time to stroke/transient ischemic attack		6 months after procedure
Other	Time to stroke/transient ischemic attack		12 months after procedure
Other	Time to stroke/transient ischemic attack		18 months after procedure
Other	Time to stroke/transient ischemic attack		24 months after procedure
Other	Time to stroke/transient ischemic attack		30 months after procedure
Other	Time to stroke/transient ischemic attack		36 months after procedure
Other	Time to stroke/transient ischemic attack		48 months after procedure
Other	Time to stroke/transient ischemic attack		60 months after procedure
Other	Time to stroke/transient ischemic attack		72 months after procedure
Other	Time to stroke/transient ischemic attack		84 months after procedure
Other	Time to stroke/transient ischemic attack		96 months after procedure
Other	Time to stroke/transient ischemic attack		108 months after procedure
Other	Time to stroke/transient ischemic attack		120 months after procedure
Other	Time to hospitalization		1 month after procedure
Other	Time to hospitalization		3 months after procedure
Other	Time to hospitalization		6 months after procedure
Other	Time to hospitalization		12 months after procedure
Other	Time to hospitalization		18 months after procedure
Other	Time to hospitalization		24 months after procedure
Other	Time to hospitalization		30 months after procedure
Other	Time to hospitalization		36 months after procedure
Other	Time to hospitalization		48 months after procedure
Other	Time to hospitalization		60 months after procedure
Other	Time to hospitalization		72 months after procedure
Other	Time to hospitalization		84 months after procedure
Other	Time to hospitalization		96 months after procedure
Other	Time to hospitalization		108 months after procedure
Other	Time to hospitalization		120 months after procedure
Other	Time to unplanned revascularization		1 month after procedure
Other	Time to unplanned revascularization		3 months after procedure
Other	Time to unplanned revascularization		6 months after procedure
Other	Time to unplanned revascularization		12 months after procedure
Other	Time to unplanned revascularization		18 months after procedure
Other	Time to unplanned revascularization		24 months after procedure
Other	Time to unplanned revascularization		30 months after procedure
Other	Time to unplanned revascularization		36 months after procedure
Other	Time to unplanned revascularization		48 months after procedure
Other	Time to unplanned revascularization		60 months after procedure
Other	Time to unplanned revascularization		72 months after procedure
Other	Time to unplanned revascularization		84 months after procedure
Other	Time to unplanned revascularization		96 months after procedure
Other	Time to unplanned revascularization		108 months after procedure
Other	Time to unplanned revascularization		120 months after procedure
Other	Time to atrial fibrillation/ atrial flutter		1 month after procedure
Other	Time to atrial fibrillation/ atrial flutter		3 months after procedure
Other	Time to atrial fibrillation/ atrial flutter		6 months after procedure
Other	Time to atrial fibrillation/ atrial flutter		12 months after procedure
Other	Time to atrial fibrillation/ atrial flutter		18 months after procedure
Other	Time to atrial fibrillation/ atrial flutter		24 months after procedure
Other	Time to atrial fibrillation/ atrial flutter		30 months after procedure
Other	Time to atrial fibrillation/ atrial flutter		36 months after procedure
Other	Time to atrial fibrillation/ atrial flutter		48 months after procedure
Other	Time to atrial fibrillation/ atrial flutter		60 months after procedure
Other	Time to atrial fibrillation/ atrial flutter		72 months after procedure
Other	Time to atrial fibrillation/ atrial flutter		84 months after procedure
Other	Time to atrial fibrillation/ atrial flutter		96 months after procedure
Other	Time to atrial fibrillation/ atrial flutter		108 months after procedure
Other	Time to atrial fibrillation/ atrial flutter		120 months after procedure
Other	Time to ventricular tachycardia/ventricular fibrillation		1 month after procedure
Other	Time to ventricular tachycardia/ventricular fibrillation		3 months after procedure
Other	Time to ventricular tachycardia/ventricular fibrillation		6 months after procedure
Other	Time to ventricular tachycardia/ventricular fibrillation		12 months after procedure
Other	Time to ventricular tachycardia/ventricular fibrillation		18 months after procedure
Other	Time to ventricular tachycardia/ventricular fibrillation		24 months after procedure
Other	Time to ventricular tachycardia/ventricular fibrillation		30 months after procedure
Other	Time to ventricular tachycardia/ventricular fibrillation		36 months after procedure
Other	Time to ventricular tachycardia/ventricular fibrillation		48 months after procedure
Other	Time to ventricular tachycardia/ventricular fibrillation		60 months after procedure
Other	Time to ventricular tachycardia/ventricular fibrillation		72 months after procedure
Other	Time to ventricular tachycardia/ventricular fibrillation		84 months after procedure
Other	Time to ventricular tachycardia/ventricular fibrillation		96 months after procedure
Other	Time to ventricular tachycardia/ventricular fibrillation		108 months after procedure
Other	Time to ventricular tachycardia/ventricular fibrillation		120 months after procedure
Other	Time to heart block		1 month after procedure
Other	Time to heart block		3 months after procedure
Other	Time to heart block		6 months after procedure
Other	Time to heart block		12 months after procedure
Other	Time to heart block		18 months after procedure
Other	Time to heart block		24 months after procedure
Other	Time to heart block		30 months after procedure
Other	Time to heart block		36 months after procedure
Other	Time to heart block		48 months after procedure
Other	Time to heart block		60 months after procedure
Other	Time to heart block		72 months after procedure
Other	Time to heart block		84 months after procedure
Other	Time to heart block		96 months after procedure
Other	Time to heart block		108 months after procedure
Other	Time to heart block		120 months after procedure
Other	Time to bleeding		1 month after procedure
Other	Time to bleeding		3 months after procedure
Other	Time to bleeding		6 months after procedure
Other	Time to bleeding		12 months after procedure
Other	Time to bleeding		18 months after procedure
Other	Time to bleeding		24 months after procedure
Other	Time to bleeding		30 months after procedure
Other	Time to bleeding		36 months after procedure
Other	Time to bleeding		48 months after procedure
Other	Time to bleeding		60 months after procedure
Other	Time to bleeding		72 months after procedure
Other	Time to bleeding		84 months after procedure
Other	Time to bleeding		96 months after procedure
Other	Time to bleeding		108 months after procedure
Other	Time to bleeding		120 months after procedure
Other	Time to vascular complications		1 month after procedure
Other	Time to vascular complications		3 months after procedure
Other	Time to vascular complications		6 months after procedure
Other	Time to vascular complications		12 months after procedure
Other	Time to vascular complications		18 months after procedure
Other	Time to vascular complications		24 months after procedure
Other	Time to vascular complications		30 months after procedure
Other	Time to vascular complications		36 months after procedure
Other	Time to vascular complications		48 months after procedure
Other	Time to vascular complications		60 months after procedure
Other	Time to vascular complications		72 months after procedure
Other	Time to vascular complications		84 months after procedure
Other	Time to vascular complications		96 months after procedure
Other	Time to vascular complications		108 months after procedure
Other	Time to vascular complications		120 months after procedure
Other	Time to heart failure		1 month after procedure
Other	Time to heart failure		3 months after procedure
Other	Time to heart failure		6 months after procedure
Other	Time to heart failure		12 months after procedure
Other	Time to heart failure		18 months after procedure
Other	Time to heart failure		24 months after procedure
Other	Time to heart failure		30 months after procedure
Other	Time to heart failure		36 months after procedure
Other	Time to heart failure		48 months after procedure
Other	Time to heart failure		60 months after procedure
Other	Time to heart failure		72 months after procedure
Other	Time to heart failure		84 months after procedure
Other	Time to heart failure		96 months after procedure
Other	Time to heart failure		108 months after procedure
Other	Time to heart failure		120 months after procedure
Other	Time to left ventricular assist device/orthotopic heart transplant		1 month after procedure
Other	Time to left ventricular assist device/orthotopic heart transplant		3 months after procedure
Other	Time to left ventricular assist device/orthotopic heart transplant		6 months after procedure
Other	Time to left ventricular assist device/orthotopic heart transplant		12 months after procedure
Other	Time to left ventricular assist device/orthotopic heart transplant		18 months after procedure
Other	Time to left ventricular assist device/orthotopic heart transplant		24 months after procedure
Other	Time to left ventricular assist device/orthotopic heart transplant		30 months after procedure
Other	Time to left ventricular assist device/orthotopic heart transplant		36 months after procedure
Other	Time to left ventricular assist device/orthotopic heart transplant		48 months after procedure
Other	Time to left ventricular assist device/orthotopic heart transplant		60 months after procedure
Other	Time to left ventricular assist device/orthotopic heart transplant		72 months after procedure
Other	Time to left ventricular assist device/orthotopic heart transplant		84 months after procedure
Other	Time to left ventricular assist device/orthotopic heart transplant		96 months after procedure
Other	Time to left ventricular assist device/orthotopic heart transplant		108 months after procedure
Other	Time to left ventricular assist device/orthotopic heart transplant		120 months after procedure
Other	Time to infection		1 month after procedure
Other	Time to infection		3 months after procedure
Other	Time to infection		6 months after procedure
Other	Time to infection		12 months after procedure
Other	Time to infection		18 months after procedure
Other	Time to infection		24 months after procedure
Other	Time to infection		30 months after procedure
Other	Time to infection		36 months after procedure
Other	Time to infection		48 months after procedure
Other	Time to infection		60 months after procedure
Other	Time to infection		72 months after procedure
Other	Time to infection		84 months after procedure
Other	Time to infection		96 months after procedure
Other	Time to infection		108 months after procedure
Other	Time to infection		120 months after procedure
Other	Time to acute kidney injury/chronic kidney disease		1 month after procedure
Other	Time to acute kidney injury/chronic kidney disease		3 months after procedure
Other	Time to acute kidney injury/chronic kidney disease		6 months after procedure
Other	Time to acute kidney injury/chronic kidney disease		12 months after procedure
Other	Time to acute kidney injury/chronic kidney disease		18 months after procedure
Other	Time to acute kidney injury/chronic kidney disease		24 months after procedure
Other	Time to acute kidney injury/chronic kidney disease		30 months after procedure
Other	Time to acute kidney injury/chronic kidney disease		36 months after procedure
Other	Time to acute kidney injury/chronic kidney disease		48 months after procedure
Other	Time to acute kidney injury/chronic kidney disease		60 months after procedure
Other	Time to acute kidney injury/chronic kidney disease		72 months after procedure
Other	Time to acute kidney injury/chronic kidney disease		84 months after procedure
Other	Time to acute kidney injury/chronic kidney disease		96 months after procedure
Other	Time to acute kidney injury/chronic kidney disease		108 months after procedure
Other	Time to acute kidney injury/chronic kidney disease		120 months after procedure
Other	Number of subjects with complete revascularization		30 days after procedure
Other	Number of subjects with reasonably complete revascularization		30 days after procedure
Other	Change in blood lipids		Baseline, 12 months post-procedure
Other	Change in hemoglobin		Baseline, 12 months post-procedure
Other	Change in LVEF		Baseline, 12 months post-procedure
Primary	Hierarchical composite of all-cause death and time-averaged change from baseline in generic quality of life using the SF-12v2	Generic quality of life (QOL) will be assessed by utilizing the 12-item Short Form Survey (SF-12v2). The score ranges from 1-100, with higher scores indicating a better health status. The win ratio will be used	5 years
Secondary	Time averaged change from baseline in disease-specific quality of life using the SAQ-OS	Disease-specific quality of life (QOL) will be assessed by utilizing the Seattle Angina Questionnaire overall summary (SAQ-OS) score. The score ranges from 1-100, with higher scores indicating a better health status.	5 years