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

Not Applicable

• Conditions: Myocardial Ischemia
• Interventions: Procedure: conventional; Procedure: no-touch

• Registration Number: NCT01834846
• Lead Sponsor: Norwegian University of Science and Technology

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-04-15
• Study First Submitted QC: 2013-04-17
• Study First Posted: 2013-04-18
• Study Start: 2013-05
• Primary Completion: 2016-12
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-31
• Last Update Posted: 2021-01-05
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
conventional	conventional	conventional technique of harvesting the saphenous vein graft for coronary artery bypass grafting
no-touch	no-touch	no-touch technique of harvesting the saphenous vein graft for coronary artery bypass grafting

Primary Outcome Measures

Name	Time	Method
Graft function	5 years	Graft function as evaluated by coronary angiography in all 100 patients

Secondary Outcome Measures

Name	Time	Method
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	5 years	Major adverse cardiac and cerebral events in all 100 patients; * Postoperative complications; * Reoperation; * Sternal dehiscence; * Mediastinitis

Trial Locations

Locations (1)

Institute for Circulation and Imaging; 🇳🇴 Trondheim, Sør-Trøndelag, Norway