CSP #557 - Coronary Artery Revascularization in Diabetes (VA CARDS)
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Coronary Artery Disease
- Sponsor
- US Department of Veterans Affairs
- Enrollment
- 198
- Locations
- 26
- Primary Endpoint
- The Hypothesis Being Tested is That a Strategy of Initial Surgical Revascularization is Superior to Percutaneous Intervention in Preventing Death or Myocardial Infarction in Diabetics With Severe Ischemic Heart Disease Assessed up to 4 Years.
- Status
- Terminated
- Last Updated
- 12 years ago
Overview
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 6.0% if treated or greater than 6.9% 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 3.7 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%.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients with diabetes with severe coronary artery disease General Inclusion Criteria
- •Age at least 18 years old
- •Patients with either Type I or Type II diabetes with a documented HbA1c greater than site ULN (If not on diabetic medication must be confirmed by a blood glucose of \>126 mg/dL fasting, or \>200mg/dL non-fasting); OR on diabetic medication with a documented physician diagnosis of diabetes mellitus.
- •No child bearing potential (if female)
- •Patient competent to provide consent
Exclusion Criteria
- •General Exclusion Criteria
- •Congenital heart disease
- •Coronary bypass surgery within the preceding one year
- •Need for concomitant cardiac surgery
- •AHA Class III decompensated heart failure or AHA Class IV heart failure
- •Undergoing PCI for hemodynamic instability related to acute STEMI
- •History of a hemorrhagic stroke
- •Severe bleeding diathesis
- •History of chronic pancreatitis
- •A severe co-morbid condition that is expected to limit life to less than two years
Outcomes
Primary Outcomes
The Hypothesis Being Tested is That a Strategy of Initial Surgical Revascularization is Superior to Percutaneous Intervention in Preventing Death or Myocardial Infarction in Diabetics With Severe Ischemic Heart Disease Assessed up to 4 Years.
Time Frame: Date of Death and non-fatal MI
Participants were monitored for up to 4 years. This is the number of particiapnts who have died or had at least one myocardial infarction.