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Coronary Artery Revascularization in Diabetes (VA CARDS)

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ClinicalTrials.gov Identifier: NCT00326196
Recruitment Status : Terminated (Lack of participant enrollment)
First Posted : May 16, 2006
Results First Posted : February 6, 2014
Last Update Posted : April 25, 2014
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Device: Percutaneous coronary intervention (PCI) Procedure: Coronary artery bypass graft (CABG) Phase 4

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%.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 198 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CSP #557 - Coronary Artery Revascularization in Diabetes (VA CARDS)
Study Start Date : July 2006
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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.



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
Criteria

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

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


  Show 26 Study Locations
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Study Chair: Masoor Kamalesh, MD Richard Roudebush VA Medical Center, Indianapolis

Publications of Results:
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00326196     History of Changes
Other Study ID Numbers: 557
First Posted: May 16, 2006    Key Record Dates
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:
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