Impact of Perivascular Tissue on Endothelial Function in Coronary Artery Bypass Grafting

Study Overview
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Brief Summary
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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.

Official Title
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Impact of Perivascular Tissue on Endothelial Function and Vessel Structure in Vein Grafts Used for Coronary Artery Bypass Grafting: A Prospective, Randomized Controlled Trial.

Conditions
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Myocardial Ischemia

Intervention / Treatment
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* Procedure: no-touch
* Procedure: conventional


Participation Criteria
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Eligibility Criteria
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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 not receiving statins

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: no-touch<br>no-touch technique of harvesting the saphenous vein graft for coronary artery bypass grafting | Procedure: no-touch<br>* The saphenous vein is exposed by a longitudinal incision, and all visible side branches ligated. The vein is then isolated together with a pedicle of surrounding tissue and manually distended and stored in a combination of blood and saline using a syringe, according to standard procedure at St. Olav's Hospital.<br>|
| Active Comparator: conventional<br>conventional technique of harvesting the saphenous vein graft for coronary artery bypass grafting | Procedure: conventional<br>* The saphenous vein is exposed by a longitudinal leg incision, skeletonized from surrounding tissue, and side branches ligated. The vein is removed from the leg immediately after dissection, manually distended and stored in a combination of blood and saline using a syringe, according to standard procedure at St. Olav's Hospital.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Graft function | Graft function as evaluated by coronary angiography in the first 60 out of 100 patients | 6 months | 
| Graft function | Graft function as evaluated by coronary angiography in all 100 patients | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morphological appearance of vein graft | As measured by angiography follow-up in the first 60 out of 100 patients | 6 months | 
| Morphological appearance of vein graft | As measured by angiography follow-up in all 100 patients | 5 years | 
| Postoperative leg wound complications | The following measures will be assessed in the first 60 out of 100 patients: Signs of infection Wound dehiscence Aesthetics Cutaneous sensory loss Wound discomfort | 6 weeks | 
| Postoperative complications related to cardiac surgery | Major adverse cardiac and cerebral events in the first 60 out of 100 patients Postoperative complications Reoperation Sternal dehiscence Mediastinitis | Discharge, 6 weeks, 6 months | 
| Postoperative complications related to cardiac surgery | Major adverse cardiac and cerebral events in all 100 patients Postoperative complications Reoperation Sternal dehiscence Mediastinitis | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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comparative study, Cardiac Surgical Procedures