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Does Prophylactic Coronary Artery Revascularization for High Risk Patients Reduce Long-term Risk of Mortality (CARP)

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.
 
ClinicalTrials.gov Identifier: NCT00032370
Recruitment Status : Completed
First Posted : March 20, 2002
Last Update Posted : June 26, 2015
Sponsor:
Information provided by:
VA Office of Research and Development

Brief Summary:
Although a number of sophisticated diagnostic tests have been shown to be helpful in identifying patients at high risk for perioperative cardiac complications, no study has addressed the most important question: Should prophylactic coronary revascularization be performed prior to elective vascular surgery? This study is designed to answer this question.

Condition or disease Intervention/treatment Phase
Cardiovascular Disease Procedure: Vascular surgery with best medical treatment Procedure: Coronary artery bypass grafting (CABG) Procedure: Percutaneous transluminal coronary angioplasty (PTCA) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 510 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: CSP #411 - The Coronary Artery Revascularization Prophylaxis (CARP) Trial
Study Start Date : August 1997
Actual Primary Completion Date : February 2004
Actual Study Completion Date : May 2004

Arm Intervention/treatment
1
Elective vascular surgery
Procedure: Vascular surgery with best medical treatment
Patients undergo scheduled vascular surgery

2
Cardiac revascularization prior to vascular surgery.
Procedure: Coronary artery bypass grafting (CABG)
Coronary artery bypass grafting prior to vascular surgery
Other Name: CABG

Procedure: Percutaneous transluminal coronary angioplasty (PTCA)
Cardiac revascularization via PTCA prior to vascular surgery
Other Name: PTCA




Primary Outcome Measures :
  1. Mortality [ Time Frame: 3 months and 3.5 years post-op ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

High risk patients scheduled for elective vascular surgery

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00032370


Locations
Show Show 18 study locations
Sponsors and Collaborators
US Department of Veterans Affairs
Investigators
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Study Chair: Edward O. McFalls, MD VA Medical Center

Publications of Results:

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Responsible Party: McFalls, Edward - Study Chair, Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00032370    
Other Study ID Numbers: 411
First Posted: March 20, 2002    Key Record Dates
Last Update Posted: June 26, 2015
Last Verified: June 2015
Keywords provided by VA Office of Research and Development:
myocardial infarction
Prophylactic coronary artery revascularization
Additional relevant MeSH terms:
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Cardiovascular Diseases