Coronary Artery Revascularization in Diabetes (VA CARDS)

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. 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
Information provided by (Responsible Party):
VA Office of Research and Development

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Coronary Artery Disease
Interventions: Device: Percutaneous coronary intervention (PCI)
Procedure: Coronary artery bypass graft (CABG)

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study recruitment occured at 23 VA medical centers and thestudy recruitment lasted from 8/25/2006 thru 3/24/2010.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Study participants were were pre-screened by Cath lab. The remaining participants were consented and screened for study eligibility.

Reporting Groups
Percutaneous Coronary Intervention Initial revascularization with Percutaneous coronary intervention. Whenever possible, drug-eluting stents will be used in the percutaneous treatment. The use of multiple stents to achieve a "complete" revascularization will be encouraged in the PCI treatment
Coronary Artery Bypass Graft Initial revascularization with Coronary artery bypass graft (CABG). Multiple arterial conduits for suitable target vessels will be encouraged in the surgical treatment.

Participant Flow:   Overall Study
    Percutaneous Coronary Intervention   Coronary Artery Bypass Graft
STARTED   101   97 
COMPLETED   101   97 

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
Percutaneous Coronary Intervention Percutaneous coronary intervention
Coronary Artery Bypass Graft Coronary artery bypass graft (CABG)
Total Total of all reporting groups

Baseline Measures
   Percutaneous Coronary Intervention   Coronary Artery Bypass Graft   Total 
Overall Participants Analyzed 
[Units: Participants]
 101   97   198 
[Units: Years]
Mean (Standard Deviation)
 62.7  (7.1)   62.1  (7.4)   62.4  (7.2) 
[Units: Participants]
Female   1   1   2 
Male   100   96   196 
Region of Enrollment 
[Units: Participants]
United States   101   97   198 

  Outcome Measures

1.  Primary:   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 ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Low participant recruitment led to the study being terminated early.

  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:  
Name/Title: Masoor Kamalesh, MD
Organization: Roudebush VAMC
phone: 317-988-2401

Publications of Results:

Responsible Party: VA Office of Research and Development 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