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Copenhagen Arterial Revascularization Randomized Patency and Outcome Trial (CARRPO)

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ClinicalTrials.gov Identifier: NCT00159991
Recruitment Status : Unknown
Verified January 2008 by Rigshospitalet, Denmark.
Recruitment status was:  Active, not recruiting
First Posted : September 12, 2005
Last Update Posted : February 15, 2008
Information provided by:

Study Description
Brief Summary:
There is a remarkable lack of randomized trials concerning the potential benefit of using arterial conduits for coronary bypass surgery. This is the purpose of the present trial. Exclusive use of arterial conduits might result in improved conduit viability, reduced risk of recurrent angina, myocardial infarction and other cardiac events, reduced need for antianginal medication, improved functional status and possibly improved long term survival. The patients will be followed for ten years after surgery.

Condition or disease Intervention/treatment Phase
Coronary Arteriosclerosis Ischemic Heart Disease Angina Pectoris Procedure: Total arterial revascularization Procedure: Conventional revascularization Phase 3

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Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 331 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Arterial Revascularization for Coronary Bypass Surgery: A Randomized Trial Comparing the Outcome After Using LIMA + Vein Grafts Versus Total Arterial Revascularization With LIMA + RIMA + Radial Artery Grafts
Study Start Date : February 2002
Estimated Primary Completion Date : February 2011
Estimated Study Completion Date : February 2015

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U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: A
Total arterial revascularization
Procedure: Total arterial revascularization
Coronary artery bypass grafting using LIMA and RIMA and/or radial artery grafts
Other Names:
  • LIMA: left internal mammary artery
  • RIMA: right internal mammary artery
Active Comparator: B
Conventional revascularization
Procedure: Conventional revascularization
Coronary artery bypass grafting using LIMA and saphenous vein grafts
Other Name: LIMA: left internal mammary artery

Outcome Measures

Primary Outcome Measures :
  1. Angiographic distal anastomotic patency rates [ Time Frame: 1, 5 and 10 years postoperatively ]
  2. Cardiac event free survival [ Time Frame: 1, 5 and 10 years postoperatively ]

Secondary Outcome Measures :
  1. Peroperative mortality [ Time Frame: Until 3 months postoperatively ]
  2. Postoperative morbidity (frequency of peroperative/ postoperative infarction, arrythmias, use of IABP, inotropic support, pulmonary, renal and cerebral complications, length of stay in the ICU, etc. according to registration schemes). [ Time Frame: 3 months postoperatively ]
  3. Risk of recurrent angina and need for antianginal medication [ Time Frame: 1, 5 and 10 years postoperatively ]
  4. Data on functional status and social rehabilitation at clinical controls [ Time Frame: 3 months, 1, 5 and 10 years postoperatively ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with 2 or 3 vessel coronary artery disease, where more than 1 coronary bypass graft is anticipated.
  • Elective or subacute operation (unstable AP with surgery within a few days)
  • Inclusion is independent of ventricular function, recent MI, degree and type of coronary lesions and secondary risk factors as diabetes, hyperlipidemia, hypertension, lung function, chronic obstructive lung disease, peripheral atherosclerotic disease, kidney function, earlier cerebrovascular disease.
  • Age: < 70 years.
  • Sufficient collateral blood supply to the hand by the ulnar artery, evaluated by the Allen test.
  • Patients must be able to give informed consent.

Exclusion Criteria:

  • Concurrent malignant disease with expected survival of < 5 years.
  • Unsuitable saphenous vein grafts evaluated preoperatively.
  • Unsuitable saphenous vein grafts with a diameter > 6mm evaluated preoperatively.
  • Acute operation (unstable hemodynamics in terms of need of inotropic support, ongoing MI with dynamic ECG changes, cardiogenic shock).
  • Concommitant operation for valve disease or other forms of heart surgery. Redo operations.
Contacts and Locations

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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): NCT00159991

Department of Cardiothoracic Surgery, Rigshospitalet
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
Danish Heart Foundation
Lundbeck Foundation
Copenhagen Hospital Corporation
Principal Investigator: Sune Damgaard, MD Dept. of Cardiothoracic Surgery, Rigshospitalet, Copenhagen
Study Director: Daniel A Steinbrüchel, Professor Dept. of Cardiothoracic Surgery, Rigshospitalet, Copenhagen
Study Chair: Jens T Lund, Consultant Dept. of Cardiothoracic Surgery, Rigshospitalet, Copenhagen
Study Chair: Henning Kelbæk, Consultant Cardiac Cath. Lab., Rigshospitalet, Copenhagen
Study Chair: Jan K Madsen, Consultant Dept. of Cardiology, Gentofte County Hospital, Copenhagen
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sune Damgaard MD, Department of Cardiothoracic Surgery, Rigshospitalet
ClinicalTrials.gov Identifier: NCT00159991     History of Changes
Other Study ID Numbers: 961502837
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: February 15, 2008
Last Verified: January 2008

Keywords provided by Rigshospitalet, Denmark:
Coronary artery bypass grafting
Total arterial revascularization
Internal mammary artery grafting
Radial artery grafting

Additional relevant MeSH terms:
Heart Diseases
Myocardial Ischemia
Coronary Artery Disease
Angina Pectoris
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arterial Occlusive Diseases
Chest Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms