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Coronary Artery Revascularization in Diabetes (VA CARDS)

Primary Purpose

Coronary Artery Disease

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Percutaneous coronary intervention (PCI)
Coronary artery bypass graft (CABG)
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring CABG, Coronary Disease, Diabetes, PCI

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients with diabetes with severe coronary artery disease General Inclusion Criteria 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 Exclusion Criteria: General Exclusion Criteria 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 Participation in another trial with active intervention Patient unable to be adequately followed

Sites / Locations

  • VA Medical Center, Birmingham
  • Southern Arizona VA Health Care System, Tucson
  • VA Palo Alto Health Care System
  • VA San Diego Healthcare System, San Diego
  • VA Medical Center, San Francisco
  • VA Greater Los Angeles HCS, Sepulveda
  • VA Eastern Colorado Health Care System, Denver
  • VA Medical Center, DC
  • VA Medical Center, Miami
  • James A. Haley Veterans Hospital, Tampa
  • Atlanta VA Medical and Rehab Center, Decatur
  • Richard Roudebush VA Medical Center, Indianapolis
  • VA Boston Healthcare System, Brockton Campus
  • VA Medical Center, Minneapolis
  • New York Harbor HCS
  • VA Medical Center, Asheville
  • VA Medical Center, Durham
  • VA Medical Center, Cleveland
  • VA Medical Center, Oklahoma City
  • Ralph H Johnson VA Medical Center, Charleston
  • VA Medical Center, Memphis
  • VA North Texas Health Care System, Dallas
  • Michael E. DeBakey VA Medical Center (152)
  • VA South Texas Health Care System, San Antonio
  • VA Puget Sound Health Care System, Seattle
  • Zablocki VA Medical Center, Milwaukee

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

PCI

CABG

Arm Description

Percutaneous coronary intervention

Coronary artery bypass graft (CABG)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
May 12, 2006
Last Updated
April 7, 2014
Sponsor
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT00326196
Brief Title
Coronary Artery Revascularization in Diabetes
Acronym
VA CARDS
Official Title
CSP #557 - Coronary Artery Revascularization in Diabetes (VA CARDS)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Terminated
Why Stopped
Lack of participant enrollment
Study Start Date
July 2006 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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%.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
CABG, Coronary Disease, Diabetes, PCI

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
198 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PCI
Arm Type
Active Comparator
Arm Description
Percutaneous coronary intervention
Arm Title
CABG
Arm Type
Active Comparator
Arm Description
Coronary artery bypass graft (CABG)
Intervention Type
Device
Intervention Name(s)
Percutaneous coronary intervention (PCI)
Intervention Description
percutaneous coronary stenting with drug eluding stents
Intervention Type
Procedure
Intervention Name(s)
Coronary artery bypass graft (CABG)
Intervention Description
coronary bypass
Primary Outcome Measure Information:
Title
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.
Description
Participants were monitored for up to 4 years. This is the number of particiapnts who have died or had at least one myocardial infarction.
Time Frame
Date of Death and non-fatal MI

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with diabetes with severe coronary artery disease General Inclusion Criteria 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 Exclusion Criteria: General Exclusion Criteria 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 Participation in another trial with active intervention Patient unable to be adequately followed
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Masoor Kamalesh, MD
Organizational Affiliation
Richard Roudebush VA Medical Center, Indianapolis
Official's Role
Study Chair
Facility Information:
Facility Name
VA Medical Center, Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Southern Arizona VA Health Care System, Tucson
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85723
Country
United States
Facility Name
VA Palo Alto Health Care System
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304-1290
Country
United States
Facility Name
VA San Diego Healthcare System, San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92161
Country
United States
Facility Name
VA Medical Center, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94121
Country
United States
Facility Name
VA Greater Los Angeles HCS, Sepulveda
City
Sepulveda
State/Province
California
ZIP/Postal Code
91343
Country
United States
Facility Name
VA Eastern Colorado Health Care System, Denver
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
VA Medical Center, DC
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20422
Country
United States
Facility Name
VA Medical Center, Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Facility Name
James A. Haley Veterans Hospital, Tampa
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Atlanta VA Medical and Rehab Center, Decatur
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Richard Roudebush VA Medical Center, Indianapolis
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202-2884
Country
United States
Facility Name
VA Boston Healthcare System, Brockton Campus
City
Brockton
State/Province
Massachusetts
ZIP/Postal Code
02301
Country
United States
Facility Name
VA Medical Center, Minneapolis
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55417
Country
United States
Facility Name
New York Harbor HCS
City
New York
State/Province
New York
ZIP/Postal Code
10010
Country
United States
Facility Name
VA Medical Center, Asheville
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28805
Country
United States
Facility Name
VA Medical Center, Durham
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
VA Medical Center, Cleveland
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
VA Medical Center, Oklahoma City
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Ralph H Johnson VA Medical Center, Charleston
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29401-5799
Country
United States
Facility Name
VA Medical Center, Memphis
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States
Facility Name
VA North Texas Health Care System, Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75216
Country
United States
Facility Name
Michael E. DeBakey VA Medical Center (152)
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
VA South Texas Health Care System, San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
VA Puget Sound Health Care System, Seattle
City
Seattle
State/Province
Washington
ZIP/Postal Code
98108
Country
United States
Facility Name
Zablocki VA Medical Center, Milwaukee
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53295-1000
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23428214
Citation
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.
Results Reference
result

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Coronary Artery Revascularization in Diabetes

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