Study Stopped
Lack of participant enrollment
Coronary Artery Revascularization in Diabetes
VA CARDS
CSP #557 - Coronary Artery Revascularization in Diabetes (VA CARDS)
1 other identifier
interventional
198
1 country
26
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 coronary-artery-disease
Started Jul 2006
Longer than P75 for phase_4 coronary-artery-disease
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 12, 2006
CompletedFirst Posted
Study publicly available on registry
May 16, 2006
CompletedStudy Start
First participant enrolled
July 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedResults Posted
Study results publicly available
February 6, 2014
CompletedApril 25, 2014
April 1, 2014
6.1 years
May 12, 2006
July 1, 2013
April 7, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
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
Study Arms (2)
PCI
ACTIVE COMPARATORPercutaneous coronary intervention
CABG
ACTIVE COMPARATORCoronary artery bypass graft (CABG)
Interventions
percutaneous coronary stenting with drug eluding stents
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (26)
VA Medical Center, Birmingham
Birmingham, Alabama, 35233, United States
Southern Arizona VA Health Care System, Tucson
Tucson, Arizona, 85723, United States
VA Palo Alto Health Care System
Palo Alto, California, 94304-1290, United States
VA San Diego Healthcare System, San Diego
San Diego, California, 92161, United States
VA Medical Center, San Francisco
San Francisco, California, 94121, United States
VA Greater Los Angeles HCS, Sepulveda
Sepulveda, California, 91343, United States
VA Eastern Colorado Health Care System, Denver
Denver, Colorado, 80220, United States
VA Medical Center, DC
Washington D.C., District of Columbia, 20422, United States
VA Medical Center, Miami
Miami, Florida, 33125, United States
James A. Haley Veterans Hospital, Tampa
Tampa, Florida, 33612, United States
Atlanta VA Medical and Rehab Center, Decatur
Decatur, Georgia, 30033, United States
Richard Roudebush VA Medical Center, Indianapolis
Indianapolis, Indiana, 46202-2884, United States
VA Boston Healthcare System, Brockton Campus
Brockton, Massachusetts, 02301, United States
VA Medical Center, Minneapolis
Minneapolis, Minnesota, 55417, United States
New York Harbor HCS
New York, New York, 10010, United States
VA Medical Center, Asheville
Asheville, North Carolina, 28805, United States
VA Medical Center, Durham
Durham, North Carolina, 27705, United States
VA Medical Center, Cleveland
Cleveland, Ohio, 44106, United States
VA Medical Center, Oklahoma City
Oklahoma City, Oklahoma, 73104, United States
Ralph H Johnson VA Medical Center, Charleston
Charleston, South Carolina, 29401-5799, United States
VA Medical Center, Memphis
Memphis, Tennessee, 38104, United States
VA North Texas Health Care System, Dallas
Dallas, Texas, 75216, United States
Michael E. DeBakey VA Medical Center (152)
Houston, Texas, 77030, United States
VA South Texas Health Care System, San Antonio
San Antonio, Texas, 78229, United States
VA Puget Sound Health Care System, Seattle
Seattle, Washington, 98108, United States
Zablocki VA Medical Center, Milwaukee
Milwaukee, Wisconsin, 53295-1000, United States
Related Publications (1)
Kamalesh M, Sharp TG, Tang XC, Shunk K, Ward HB, Walsh J, King S 3rd, Colling C, Moritz T, Stroupe K, Reda D; VA CARDS Investigators. Percutaneous coronary intervention versus coronary bypass surgery in United States veterans with diabetes. J Am Coll Cardiol. 2013 Feb 26;61(8):808-16. doi: 10.1016/j.jacc.2012.11.044.
PMID: 23428214RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Low participant recruitment led to the study being terminated early.
Results Point of Contact
- Title
- Masoor Kamalesh, MD
- Organization
- Roudebush VAMC
Study Officials
- STUDY CHAIR
Masoor Kamalesh, MD
Richard Roudebush VA Medical Center, Indianapolis
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 12, 2006
First Posted
May 16, 2006
Study Start
July 1, 2006
Primary Completion
August 1, 2012
Study Completion
August 1, 2012
Last Updated
April 25, 2014
Results First Posted
February 6, 2014
Record last verified: 2014-04