Status:
UNKNOWN
Copenhagen Arterial Revascularization Randomized Patency and Outcome Trial
Lead Sponsor:
Rigshospitalet, Denmark
Collaborating Sponsors:
Danish Heart Foundation
Lundbeck Foundation
Conditions:
Coronary Arteriosclerosis
Ischemic Heart Disease
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
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 arte...
Detailed Description
I: Background There is a remarkable lack of randomized studies concerning the potential benefit of using arterial grafts for coronary revascularization. Numerous observational reports consistently co...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
331 Patients enrolled
Trial Details
Trial ID
NCT00159991
Start Date
February 1 2002
End Date
February 1 2015
Last Update
February 15 2008
Active Locations (1)
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1
Department of Cardiothoracic Surgery, Rigshospitalet
Copenhagen, Denmark, 2100