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

Myocardial Ischemia Clinical Trial

— IMPROVE-CABG  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01834846
• Other study ID #: 090486
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 2013
• Est. completion date: December 2021

Study information

• Verified date: December 2020
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: December 2021
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ischemia
• Myocardial Ischemia

Intervention

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.
• 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.

Locations

Country	Name	City	State
Norway	Institute for Circulation and Imaging	Trondheim	Sør-Trøndelag

Sponsors (2)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (2)

Pettersen Ø, Haram PM, Winnerkvist A, Karevold A, Wahba A, Stenvik M, Wiseth R, Hegbom K, Nordhaug DO. Pedicled Vein Grafts in Coronary Surgery: Perioperative Data From a Randomized Trial. Ann Thorac Surg. 2017 Oct;104(4):1313-1317. doi: 10.1016/j.athorac — View Citation

Pettersen Ø, Wiseth R, Hegbom K, Nordhaug DO. Pedicled Vein Grafts in Coronary Surgery Exhibit Reduced Intimal Hyperplasia at 6 Months. J Am Coll Cardiol. 2016 Jul 26;68(4):427-9. doi: 10.1016/j.jacc.2016.04.058. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Graft function	Graft function as evaluated by coronary angiography in the first 60 out of 100 patients	6 months
Primary	Graft function	Graft function as evaluated by coronary angiography in all 100 patients	5 years
Secondary	Morphological appearance of vein graft	As measured by angiography follow-up in the first 60 out of 100 patients	6 months
Secondary	Morphological appearance of vein graft	As measured by angiography follow-up in all 100 patients	5 years
Secondary	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
Secondary	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
Secondary	Postoperative complications related to cardiac surgery	Major adverse cardiac and cerebral events in all 100 patients; Postoperative complications; Reoperation; Sternal dehiscence; Mediastinitis	5 years