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

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

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.

Study Overview

• Status: Unknown
• Conditions: Myocardial Ischemia
• Intervention / Treatment: Procedure: no-touch; Procedure: conventional

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Sør-Trøndelag
    • Trondheim, Sør-Trøndelag, Norway, 7042
      • Institute for Circulation and Imaging

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Graft function	Graft function as evaluated by coronary angiography in the first 60 out of 100 patients	6 months
Graft function	Graft function as evaluated by coronary angiography in all 100 patients	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Morphological appearance of vein graft	As measured by angiography follow-up in the first 60 out of 100 patients	6 months
Morphological appearance of vein graft	As measured by angiography follow-up in all 100 patients	5 years
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
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
Postoperative complications related to cardiac surgery	Major adverse cardiac and cerebral events in all 100 patients; Postoperative complications; Reoperation; Sternal dehiscence; Mediastinitis	5 years

Collaborators and Investigators

• Sponsor: Norwegian University of Science and Technology
• Collaborators: St. Olavs Hospital
• Investigators: Principal Investigator: Dag Ole Nordhaug, md phd, Norwegian University of Science and Technology

Publications and helpful links

General Publications

• Pettersen O, 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. No abstract available.
• Pettersen O, 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.athoracsur.2017.03.076. Epub 2017 Jun 23.
• Pettersen O, Pociask E, Malinowski KP, Slezak M, Hegbom K, Wiseth R, Nordhaug DO. Reproducibility of optical coherence tomography in vein grafts used for coronary revascularization. Cardiol J. 2020;27(5):518-523. doi: 10.5603/CJ.a2018.0139. Epub 2018 Nov 16.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2013
• Primary Completion (Actual): December 1, 2016
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: April 15, 2013
• First Submitted That Met QC Criteria: April 17, 2013
• First Posted (Estimate): April 18, 2013

Study Record Updates

• Last Update Posted (Actual): January 5, 2021
• Last Update Submitted That Met QC Criteria: December 31, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: comparative study; Cardiac Surgical Procedures
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Ischemia; Ischemia
• Other Study ID Numbers: 090486

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No