Impact of Perivascular Tissue on Endothelial Function in Coronary Artery Bypass Grafting (IMPROVE-CABG)

Norwegian University of Science and Technology

Status: Unknown

Conditions: Myocardial Ischemia

Treatments: Procedure: conventional; Procedure: no-touch

Study type: Interventional

Funder types: Other

Identifiers

NCT01834846

090486

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

100 participants in 2 patient groups

no-touch

Experimental group

Description:

no-touch technique of harvesting the saphenous vein graft for coronary artery bypass grafting

Treatment:

Procedure: no-touch

conventional

Active Comparator group

Description:

conventional technique of harvesting the saphenous vein graft for coronary artery bypass grafting

Treatment:

Procedure: conventional