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Coronary Artery Revascularization in Diabetes (VA CARDS)

This study has been terminated.
(Lack of participant enrollment)
ClinicalTrials.gov Identifier:
First Posted: May 16, 2006
Last Update Posted: April 25, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
VA Office of Research and Development
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
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CSP #557 - Coronary Artery Revascularization in Diabetes (VA CARDS)

Resource links provided by NLM:

Further study details as provided by VA Office of Research and Development:

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 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.

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%.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Patients with diabetes with severe coronary artery disease General Inclusion Criteria

  1. Age at least 18 years old
  2. 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.
  3. No child bearing potential (if female)
  4. Patient competent to provide consent

    Exclusion Criteria:

    General Exclusion Criteria

  5. Congenital heart disease
  6. Coronary bypass surgery within the preceding one year
  7. Need for concomitant cardiac surgery
  8. AHA Class III decompensated heart failure or AHA Class IV heart failure
  9. Undergoing PCI for hemodynamic instability related to acute STEMI
  10. History of a hemorrhagic stroke
  11. Severe bleeding diathesis
  12. History of chronic pancreatitis
  13. A severe co-morbid condition that is expected to limit life to less than two years
  14. Embolic stroke in the past six months
  15. Significant GI bleed within the last one month
  16. Lack of adequate surgical conduit
  17. Sensitivity to clopidogrel (Plavix)
  18. Sensitivity to glycoprotein IIb/IIIa inhibitors
  19. Chronic systemic steroid use
  20. Participation in another trial with active intervention
  21. Patient unable to be adequately followed
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00326196

  Hide Study Locations
United States, Alabama
VA Medical Center, Birmingham
Birmingham, Alabama, United States, 35233
United States, Arizona
Southern Arizona VA Health Care System, Tucson
Tucson, Arizona, United States, 85723
United States, California
VA Palo Alto Health Care System
Palo Alto, California, United States, 94304-1290
VA San Diego Healthcare System, San Diego
San Diego, California, United States, 92161
VA Medical Center, San Francisco
San Francisco, California, United States, 94121
VA Greater Los Angeles HCS, Sepulveda
Sepulveda, California, United States, 91343
United States, Colorado
VA Eastern Colorado Health Care System, Denver
Denver, Colorado, United States, 80220
United States, District of Columbia
VA Medical Center, DC
Washington, District of Columbia, United States, 20422
United States, Florida
VA Medical Center, Miami
Miami, Florida, United States, 33125
James A. Haley Veterans Hospital, Tampa
Tampa, Florida, United States, 33612
United States, Georgia
Atlanta VA Medical and Rehab Center, Decatur
Decatur, Georgia, United States, 30033
United States, Indiana
Richard Roudebush VA Medical Center, Indianapolis
Indianapolis, Indiana, United States, 46202-2884
United States, Massachusetts
VA Boston Healthcare System, Brockton Campus
Brockton, Massachusetts, United States, 02301
United States, Minnesota
VA Medical Center, Minneapolis
Minneapolis, Minnesota, United States, 55417
United States, New York
New York Harbor HCS
New York, New York, United States, 10010
United States, North Carolina
VA Medical Center, Asheville
Asheville, North Carolina, United States, 28805
VA Medical Center, Durham
Durham, North Carolina, United States, 27705
United States, Ohio
VA Medical Center, Cleveland
Cleveland, Ohio, United States, 44106
United States, Oklahoma
VA Medical Center, Oklahoma City
Oklahoma City, Oklahoma, United States, 73104
United States, South Carolina
Ralph H Johnson VA Medical Center, Charleston
Charleston, South Carolina, United States, 29401-5799
United States, Tennessee
VA Medical Center, Memphis
Memphis, Tennessee, United States, 38104
United States, Texas
VA North Texas Health Care System, Dallas
Dallas, Texas, United States, 75216
Michael E. DeBakey VA Medical Center (152)
Houston, Texas, United States, 77030
VA South Texas Health Care System, San Antonio
San Antonio, Texas, United States, 78229
United States, Washington
VA Puget Sound Health Care System, Seattle
Seattle, Washington, United States, 98108
United States, Wisconsin
Zablocki VA Medical Center, Milwaukee
Milwaukee, Wisconsin, United States, 53295-1000
Sponsors and Collaborators
VA Office of Research and Development
Study Chair: Masoor Kamalesh, MD Richard Roudebush VA Medical Center, Indianapolis
  More Information

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00326196     History of Changes
Other Study ID Numbers: 557
First Submitted: May 12, 2006
First Posted: May 16, 2006
Results First Submitted: July 1, 2013
Results First Posted: February 6, 2014
Last Update Posted: April 25, 2014
Last Verified: April 2014

Keywords provided by VA Office of Research and Development:
Coronary Disease

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases