NCT01834846
Unknown
Not Applicable
Impact of Perivascular Tissue on Endothelial Function and Vessel Structure in Vein Grafts Used for Coronary Artery Bypass Grafting: A Prospective, Randomized Controlled Trial.
ConditionsMyocardial Ischemia
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Myocardial Ischemia
- Sponsor
- Norwegian University of Science and Technology
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Graft function
- Last Updated
- 5 years ago
Overview
Brief Summary
The success of coronary artery bypass grafting is reliant on the quality of the grafts used. A new technique for harvesting veins used as grafts has been introduced. The study hypothesis is that veins harvested with this technique have an improved endothelial function.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Isolated elective, primary CABG requiring cardiopulmonary bypass
- •Left ventricular ejection fraction \>35%
- •at least one saphenous vein graft required as part of revascularization strategy
Exclusion Criteria
- •Acute or chronic inflammatory diseases
- •Malignancies
- •Pregnancy
- •Previous cardiac surgery
- •Serum creatinine \>120 μmol/L
- •Coagulopathy
- •Insulin dependent diabetes mellitus
- •Smoking during last 6 months
- •Leg not suitable for No-touch vein harvesting as judged by the operator.
- •Need for nitrates on operation day
Outcomes
Primary Outcomes
Graft function
Time Frame: 5 years
Graft function as evaluated by coronary angiography in all 100 patients
Secondary Outcomes
- Morphological appearance of vein graft(5 years)
- Postoperative leg wound complications(6 weeks)
- Postoperative complications related to cardiac surgery(5 years)
Study Sites (1)
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