Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06399705
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-26
First Post:
2024-04-30
Brief Title:
REvascularization CHoices Among Under-Represented Groups Evaluation The RECHARGE Trial
Sponsor:
Weill Medical College of Cornell University
Organization:
Weill Medical College of Cornell University
Study Overview
Official Title:
REvascularization CHoices Among Under-Represented Groups Evaluation The RECHARGE Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RECHARGEM
Brief 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 andor forearm are used to bypass the blockages like a detour Outcomes will be measured by comparing survival and improvement in quality-of-life
Detailed Description:
The RECHARGE Minorities Trial is a multicenter 11 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None