Coronary Artery Revascularization in Diabetes (VA CARDS)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Coronary Artery Disease |
Device: Percutaneous coronary intervention (PCI) Procedure: Coronary artery bypass graft (CABG) |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | CSP #557 - Coronary Artery Revascularization in Diabetes (VA CARDS) |
- 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. [ Time Frame: Date of Death and non-fatal MI ] [ Designated as safety issue: No ]
- To include the costs associated with each treatment strategy [ Time Frame: Date of Death and non-fatal MI ] [ Designated as safety issue: No ]
- Patient health status following each type of revascularization [ Time Frame: Date of Death and non-fatal MI ] [ Designated as safety issue: No ]
- To develop risk models for predicting procedure-related outcomes in diabetic patients undergoing revascularization to develop risk models for predicting procedure-related outcomes in diabetic patients undergoing revascularization [ Time Frame: Date of Death and non-fatal MI ] [ Designated as safety issue: No ]
- To examine angiographic myocardial jeopardy as a predictor of adverse outcomes following revascularization [ Time Frame: Date of Death and non-fatal MI ] [ Designated as safety issue: No ]
| Enrollment: | 198 |
| Study Start Date: | July 2006 |
| Study Completion Date: | August 2012 |
| Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: PCI
Percutaneous coronary intervention
|
Device: Percutaneous coronary intervention (PCI)
percutaneous coronary stenting with drug eluding stents
Procedure: Coronary artery bypass graft (CABG)
coronary bypass
|
|
Active Comparator: CABG
Coronary artery bypass graft (CABG)
|
Procedure: Coronary artery bypass graft (CABG)
coronary bypass
|
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%.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
- Embolic stroke in the past six months
- Significant GI bleed within the last one month
- Lack of adequate surgical conduit
- Sensitivity to clopidogrel (Plavix)
- Sensitivity to glycoprotein IIb/IIIa inhibitors
- Chronic systemic steroid use
- Participation in another trial with active intervention
- Patient unable to be adequately followed
Contacts and Locations
Show 26 Study Locations| Study Chair: | Masoor Kamalesh, MD | Richard Roudebush VA Medical Center, Indianapolis |
More Information
Publications:
| Responsible Party: | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT00326196 History of Changes |
| Other Study ID Numbers: | 557 |
| Study First Received: | May 12, 2006 |
| Last Updated: | April 24, 2013 |
| Health Authority: | United States: Federal Government United States: Food and Drug Administration |
Keywords provided by Department of Veterans Affairs:
|
CABG Coronary Disease Diabetes PCI |
Additional relevant MeSH terms:
|
Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases |
Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases |
ClinicalTrials.gov processed this record on May 16, 2013