Coronary Artery Revascularization in Diabetes (VA CARDS)

April 7, 2014 updated by: US Department of Veterans Affairs

CSP #557 - Coronary Artery Revascularization in Diabetes (VA CARDS)

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Enrollment (Actual)

198

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Date of Death and non-fatal MI

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

US Department of Veterans Affairs

Investigators

  • Study Chair: Masoor Kamalesh, MD, Richard Roudebush VA Medical Center, Indianapolis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

May 12, 2006

First Submitted That Met QC Criteria

May 12, 2006

First Posted (Estimate)

May 16, 2006

Study Record Updates

Last Update Posted (Estimate)

April 25, 2014

Last Update Submitted That Met QC Criteria

April 7, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 557 (Other Identifier: Istanbul Medipol University Ethics Commitee)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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