Back to results

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

Primary Purpose

Myocardial Ischemia

Status

Unknown status

Phase

Not Applicable

Locations

Norway

Study Type

Interventional

Intervention

no-touch

conventional

About this trial

This is an interventional treatment trial for Myocardial Ischemia focused on measuring comparative study, Cardiac Surgical Procedures

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Institute for Circulation and Imaging

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

no-touch

conventional

Arm Description

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

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

Outcomes

Primary Outcome Measures

Graft function

Graft function as evaluated by coronary angiography in the first 60 out of 100 patients

Graft function

Graft function as evaluated by coronary angiography in all 100 patients

Secondary Outcome Measures

Morphological appearance of vein graft

As measured by angiography follow-up in the first 60 out of 100 patients

Morphological appearance of vein graft

As measured by angiography follow-up in all 100 patients

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

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

Postoperative complications related to cardiac surgery

Major adverse cardiac and cerebral events in all 100 patients Postoperative complications Reoperation Sternal dehiscence Mediastinitis

Full Information

NCT ID

NCT01834846

First Posted

April 15, 2013

Last Updated

December 31, 2020

Sponsor

Norwegian University of Science and Technology

Collaborators

St. Olavs Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01834846

Brief Title

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

Acronym

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.

Study Type

Interventional

2. Study Status

Record Verification Date

December 2020

Overall Recruitment Status

Unknown status

Study Start Date

May 2013 (Actual)

Primary Completion Date

December 2016 (Actual)

Study Completion Date

December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Norwegian University of Science and Technology

Collaborators

St. Olavs Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Myocardial Ischemia

Keywords

comparative study, Cardiac Surgical Procedures

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

no-touch

Arm Type

Experimental

Arm Description

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

Arm Title

conventional

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

no-touch

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

conventional

Intervention Description

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.

Primary Outcome Measure Information:

Title

Graft function

Description

Graft function as evaluated by coronary angiography in the first 60 out of 100 patients

Time Frame

6 months

Title

Graft function

Description

Graft function as evaluated by coronary angiography in all 100 patients

Time Frame

5 years

Secondary Outcome Measure Information:

Title

Morphological appearance of vein graft

Description

As measured by angiography follow-up in the first 60 out of 100 patients

Time Frame

6 months

Title

Morphological appearance of vein graft

Description

As measured by angiography follow-up in all 100 patients

Time Frame

5 years

Title

Postoperative leg wound complications

Description

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

Time Frame

6 weeks

Title

Postoperative complications related to cardiac surgery

Description

Major adverse cardiac and cerebral events in the first 60 out of 100 patients Postoperative complications Reoperation Sternal dehiscence Mediastinitis

Time Frame

Discharge, 6 weeks, 6 months

Title

Postoperative complications related to cardiac surgery

Description

Major adverse cardiac and cerebral events in all 100 patients Postoperative complications Reoperation Sternal dehiscence Mediastinitis

Time Frame

5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dag Ole Nordhaug, md phd

Organizational Affiliation

Norwegian University of Science and Technology

Official's Role

Principal Investigator

Facility Information:

Facility Name

Institute for Circulation and Imaging

City

Trondheim

State/Province

Sør-Trøndelag

ZIP/Postal Code

7042

Country

Norway

12. IPD Sharing Statement

Citations:

PubMed Identifier

27443441

Citation

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.

Results Reference

result

PubMed Identifier

28648540

Citation

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.

Results Reference

result

PubMed Identifier

30444258

Citation

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.

Results Reference

derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs