Coronary Artery Revascularization in Diabetes (VA CARDS)

This study has been terminated.
(Lack of participant enrollment)
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00326196
First received: May 12, 2006
Last updated: April 7, 2014
Last verified: April 2014
Results First Received: July 1, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Coronary Artery Disease
Interventions: Device: Percutaneous coronary intervention (PCI)
Procedure: Coronary artery bypass graft (CABG)

  Participant Flow
  Hide 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
  Description
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  
NOT COMPLETED     0     0  



  Baseline Characteristics
  Hide 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
  Description
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  
Number of Participants  
[units: participants]
  101     97     198  
Age  
[units: years]
Mean ± Standard Deviation
  62.7  ± 7.1     62.1  ± 7.4     62.4  ± 7.2  
Gender  
[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
  Hide 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
  Hide 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
e-mail: masoor.kamalesh@va.gov


Publications of Results:

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00326196     History of Changes
Other Study ID Numbers: 557
Study First Received: May 12, 2006
Results First Received: July 1, 2013
Last Updated: April 7, 2014
Health Authority: United States: Federal Government
United States: Food and Drug Administration