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

June 25, 2015 updated by: US Department of Veterans Affairs

CSP #411 - The Coronary Artery Revascularization Prophylaxis (CARP) Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Primary Hypothesis: Prophylactic coronary artery revascularization in high risk patients scheduled for elective vascular surgery reduces long-term risk of mortality.

Secondary Hypotheses: Prophylactic coronary artery revascularization in high risk patients scheduled for elective vascular surgery reduces long-term risk of myocardial infarction and improves both cost-effectiveness of treatment and quality of life of the patients.

Intervention: 1) Medical therapy. This is the current, conservative practice. Each local investigator will decide the best medical treatment consistent with that given to any patient scheduled for elective vascular surgery. In patients with coronary artery disease, long-term treatment would be expected to include a combination of antiplatelet agents, beta-blockers, calcium channel blockers, and nitrates. Vascular surgery should occur as soon as possible but no later than three months after randomization. 2) Coronary artery revascularization. Repair of the heart in patients with coronary artery disease may aid in the protection of these patients when they undergo vascular surgery. The surgeon is free to choose between coronary artery bypass grafting (CABG) and percutaneous transluminal coronary angioplasty (PTCA). Coronary artery revascularization should occur as soon as possible after randomization. Vascular surgery should occur between one and three months following CABG or between three to four days and three months following PTCA.

Primary Outcomes: Long-term mortality, MI, and quality of life.

Study Abstract: Cardiovascular disease accounts for one million deaths per year and is the major cause of mortality among Americans. Studies have shown that in patients scheduled for elective vascular surgery, the prevalence of coronary artery disease exceeds 50%. It is not surprising, therefore, that "perioperative cardiac morbidity" defined as the occurrence of MI, unstable angina, CHF, arrhythmias, and cardiac death, is the leading cause of perioperative complications. 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.

STUDY DESIGN This proposal utilizes a prospective, randomized trial to test whether prophylactic coronary revascularization reduces perioperative cardiac complications and long term mortality in patients who undergo elective vascular surgery. All VA patients requiring elective vascular surgery will be screened for enrollment. Patients will be excluded from enrollment if they need urgent/emergent vascular surgery; have had previous coronary artery revascularization with no current ischemia; or have one or more serious medical conditions such as COPD (FEV1<1.0), renal dysfunction (creatinine >3.5 mg/dl), liver failure, metastatic cancer, severe dementia, stroke, or unstable angina. Eligibility for the study is based on results from coronary angiography. Patients having clinical risk factors (including history of MI, pathologic Q-waves, ventricular ectopy requiring antiarrhythmic therapy, diabetes, angina, and CHF); and/or a positive stress test; should be candidates for coronary angiography. Specific angiographic criteria will exclude individuals from subsequent randomization. These include normal coronary arteries, severe LV dysfunction (EF<20%), aortic valve area <1 cm2, and left main disease (or equivalent). Patients considered nonintervenable by the cardiologist or cardiac surgeon will also be excluded. Enrolled patients who do not meet any of the exclusion criteria will then be randomized to either medical treatment or prophylactic revascularization. The decision to proceed with either PTCA or CABG will be based on institutional experiences. The study design does not compare PTCA versus CABG, but rather tests whether any revascularization procedure proves beneficial. The stratification factors will be the participating hospital and the type of vascular procedure that has been proposed (intraabdominal or infrainguinal). The randomization scheme is stratified by type of vascular surgery because aortic procedures (intraabdominal) may carry more risk than peripheral procedures (infrainguinal).

STATISTICAL CONSIDERATIONS For this trial, a sample size of 560 randomized patients will be required. This will provide 90% power to detect a difference in 3.5 year survival rates of 85% for patients receiving prophylactic coronary artery revascularization versus 75% for patients receiving medical treatment. Allowing for a 10% post randomization dropout rate, the target sample size will be 620 patients. Assuming an average intake of one patient per hospital per month, 18 participating hospitals will be required.

STUDY PHASES The study originally was funded for a one year pilot phase. The purpose of this phase was to determine the feasibility of randomizing one patient per hospital per month. In order for the study to enter the main phase, five pilot hospitals, ranging in number of vascular surgery cases from low to high, had to achieve at least 90% of patient accrual expectations (54 out of an expected 60 patients randomized in one year). After successful completion of the pilot phase, the main study was approved. During the main phase, 18 participating hospitals will accrue patients for four years and continue postvascular surgery follow-up for one year.

Study Type

Interventional

Enrollment (Actual)

510

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85723
        • Southern Arizona VA Health Care System, Tucson
    • Arkansas
      • No. Little Rock, Arkansas, United States, 72114-1706
        • Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little Rock
    • California
      • San Francisco, California, United States, 94121
        • VA Medical Center, San Francisco
      • West Los Angeles, California, United States, 90073
        • VA Greater Los Angeles Healthcare System, West LA
    • Colorado
      • Denver, Colorado, United States, 80220
        • VA Eastern Colorado Health Care System, Denver
    • Florida
      • Gainesville, Florida, United States, 32608
        • North Florida/South Georgia Veterans Health System
      • Tampa, Florida, United States, 33612
        • James A. Haley Veterans Hospital, Tampa
    • Georgia
      • Decatur, Georgia, United States, 30033
        • Atlanta VA Medical and Rehab Center, Decatur
    • Indiana
      • Indianapolis, Indiana, United States, 46202-2884
        • Richard Roudebush VA Medical Center, Indianapolis
    • Minnesota
      • Minneapolis, Minnesota, United States, 55417
        • Va Medical Center
    • New Mexico
      • Albuquerque, New Mexico, United States, 87108-5153
        • New Mexico VA Health Care System, Albuquerque
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • VA Medical Center, Durham
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • VA Medical Center, Cleveland
    • Oregon
      • Portland, Oregon, United States, 97201
        • VA Medical Center, Portland
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15240
        • VA Pittsburgh Health Care System
    • Texas
      • Dallas, Texas, United States, 75216
        • VA North Texas Health Care System, Dallas
      • San Antonio, Texas, United States, 78229
        • VA South Texas Health Care System, San Antonio
    • Washington
      • Seattle, Washington, United States, 98108
        • VA Puget Sound Health Care System, Seattle

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

High risk patients scheduled for elective vascular surgery

Exclusion Criteria:

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 1
Elective vascular surgery
Procedure: Vascular surgery with best medical treatment
Patients undergo scheduled vascular surgery
Other: 2
Cardiac revascularization prior to vascular surgery.
Procedure: Coronary artery bypass grafting (CABG)
Coronary artery bypass grafting prior to vascular surgery
Other Names:
  • CABG
Procedure: Percutaneous transluminal coronary angioplasty (PTCA)
Cardiac revascularization via PTCA prior to vascular surgery
Other Names:
  • PTCA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mortality
Time Frame: 3 months and 3.5 years post-op
3 months and 3.5 years post-op

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

US Department of Veterans Affairs

Investigators

  • Study Chair: Edward O. McFalls, MD, Va Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 1997

Primary Completion (Actual)

February 1, 2004

Study Completion (Actual)

May 1, 2004

Study Registration Dates

First Submitted

March 19, 2002

First Submitted That Met QC Criteria

March 19, 2002

First Posted (Estimate)

March 20, 2002

Study Record Updates

Last Update Posted (Estimate)

June 26, 2015

Last Update Submitted That Met QC Criteria

June 25, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 411

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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