IMPROVE-CABG: Impact of Perivascular Tissue on Endothelial Function in Coronary Artery Bypass Grafting
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: no-touch no-touch technique of harvesting the saphenous vein graft for coronary artery bypass grafting |
Procedure: no-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.
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| Active Comparator: conventional conventional technique of harvesting the saphenous vein graft for coronary artery bypass grafting |
Procedure: conventional
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.
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Outcome Measures
Primary Outcome Measures
- Graft function [6 months]
Graft function as evaluated by coronary angiography in the first 60 out of 100 patients
- Graft function [5 years]
Graft function as evaluated by coronary angiography in all 100 patients
Secondary Outcome Measures
- Morphological appearance of vein graft [6 months]
As measured by angiography follow-up in the first 60 out of 100 patients
- Morphological appearance of vein graft [5 years]
As measured by angiography follow-up in all 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
- Postoperative complications related to cardiac surgery [5 years]
Major adverse cardiac and cerebral events in all 100 patients Postoperative complications Reoperation Sternal dehiscence Mediastinitis
Eligibility Criteria
Criteria
Inclusion Criteria:
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Isolated elective, primary CABG requiring cardiopulmonary bypass
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Left ventricular ejection fraction >35%
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at least one saphenous vein graft required as part of revascularization strategy
Exclusion Criteria:
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Acute or chronic inflammatory diseases
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Malignancies
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Pregnancy
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Previous cardiac surgery
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Serum creatinine >120 μmol/L
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Coagulopathy
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Insulin dependent diabetes mellitus
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Smoking during last 6 months
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Leg not suitable for No-touch vein harvesting as judged by the operator.
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Need for nitrates on operation day
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not receiving statins
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Institute for Circulation and Imaging | Trondheim | Sør-Trøndelag | Norway | 7042 |
Sponsors and Collaborators
- Norwegian University of Science and Technology
- St. Olavs Hospital
Investigators
- Principal Investigator: Dag Ole Nordhaug, md phd, Norwegian University of Science and Technology
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 090486