Myocardial Ischemia
Conditions
Keywords
comparative study, Cardiac Surgical Procedures
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.
Interventions
PROCEDUREno-touch
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.
PROCEDUREconventional
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.
Sponsors
St. Olavs Hospital
Norwegian University of Science and Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Graft function | 6 months | Graft function as evaluated by coronary angiography in the first 60 out of 100 patients |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Morphological appearance of vein graft | 6 months | As measured by angiography follow-up in the first 60 out of 100 patients |
| Postoperative leg wound complications | 6 weeks | 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 |
| Postoperative complications related to cardiac surgery | Discharge, 6 weeks, 6 months | Major adverse cardiac and cerebral events in the first 60 out of 100 patients * Postoperative complications * Reoperation * Sternal dehiscence * Mediastinitis |
Countries
Norway
Outcome results
None listed