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Coronary Artery Revascularization in Diabetes
This study is currently recruiting participants.
Verified by Department of Veterans Affairs, January 2010
First Received: May 12, 2006   Last Updated: January 29, 2010   History of Changes
Sponsor: Department of Veterans Affairs
Information provided by: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00326196
  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
Procedure: Percutaneous coronary intervention (PCI)
Procedure: Coronary artery bypass graft (CABG)
Phase IV

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study
Official Title: CSP #557 - Coronary Artery Revascularization in Diabetes (VA CARDS)

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 revascularizationTo 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 ]

Estimated Enrollment: 790
Study Start Date: July 2006
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1 Procedure: Percutaneous coronary intervention (PCI)
percutaneous coronary stenting with drug eluding stents
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
Criteria

Inclusion Criteria:

Patients with diabetes with severe coronary artery disease

Exclusion Criteria:

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00326196

Contacts
Contact: Masoor Kamalesh, MD (317) 988-2081 Masoor.Kamalesh@va.gov
Contact: Vicki R Williams, RN (317) 988-2054 vicki.williams@va.gov

  Show 26 Study Locations
Sponsors and Collaborators
Investigators
Study Chair: Masoor Kamalesh, MD Richard Roudebush VA Medical Center, Indianapolis
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs ( Kamalesh, Masoor - Study Chair )
Study ID Numbers: 557
Study First Received: May 12, 2006
Last Updated: January 29, 2010
ClinicalTrials.gov Identifier: NCT00326196     History of Changes
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:
Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Cardiovascular Diseases
Arteriosclerosis
Coronary Artery Disease

ClinicalTrials.gov processed this record on February 08, 2010