Ignite Creation Date:
2024-05-05 @ 4:51 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00326196
Status:
TERMINATED
Last Update Posted:
2014-04-25
First Post:
2006-05-12
Brief Title:
Coronary Artery Revascularization in Diabetes
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
CSP 557 - Coronary Artery Revascularization in Diabetes VA CARDS
Status:
TERMINATED
Status Verified Date:
2014-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of participant enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VA CARDS
Brief Summary:
This is a randomized multi-site clinical trial comparing percutaneous coronary stenting PCI with drug eluding stents to coronary bypass for angiographically significant coronary artery disease in diabetes The hypothesis being tested is that a strategy of surgical revascularization is superior to percutaneous intervention in preventing death or myocardial infarction in diabetics with severe ischemic heart disease
Detailed Description:
Diabetic patients HbA1c greater than 60 if treated or greater than 69 untreated with severe ischemic heart disease and clinical indications for coronary revascularization will be screened and if agreeable entered into the study Qualified patients unwilling to participate in the randomized trial will be approached for participation in a Registry that will collect computerized health data The study consists of a 4-year accrual period The median follow-up will be 37 years with a maximum of six years and a minimum of two years Six sites will begin recruitment in the first year followed by nine additional sites for the remaining three years The study is powered to detect a 40 relative difference between the groups in time to death or MI with a two-sided type I error of 5 and a power of 90
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None