Ischemic Heart Disease Clinical Trial
— CARRPOOfficial 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
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.
Status | Active, not recruiting |
Enrollment | 331 |
Est. completion date | February 2015 |
Est. primary completion date | February 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Denmark | Department of Cardiothoracic Surgery, Rigshospitalet | Copenhagen |
Lead Sponsor | Collaborator |
---|---|
Rigshospitalet, Denmark | Copenhagen Hospital Corporation, Danish Heart Foundation, Lundbeck Foundation |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Angiographic distal anastomotic patency rates | 1, 5 and 10 years postoperatively | No | |
Primary | Cardiac event free survival | 1, 5 and 10 years postoperatively | No | |
Secondary | Peroperative mortality | Until 3 months postoperatively | Yes | |
Secondary | 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). | 3 months postoperatively | Yes | |
Secondary | Risk of recurrent angina and need for antianginal medication | 1, 5 and 10 years postoperatively | No | |
Secondary | Data on functional status and social rehabilitation at clinical controls | 3 months, 1, 5 and 10 years postoperatively | No |
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