Suspended

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

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What is being tested

no-touch

+ conventional

Procedure
Who is being recruted

Cardiovascular Diseases+1

+ Heart Diseases

+ Vascular Diseases

Over 18 Years
+14 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: May 2013
See protocol details

Summary

Principal SponsorNorwegian University of Science and Technology
Last updated: January 5, 2021
Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 2013

Actual date on which the first participant was enrolled.

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.

NCT01834846
Principal SponsorNorwegian University of Science and Technology
Last updated: January 5, 2021
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

100 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Cardiovascular DiseasesHeart DiseasesVascular DiseasesMyocardial Ischemia

Criteria

3 inclusion criteria required to participate
Isolated elective, primary CABG requiring cardiopulmonary bypass
Left ventricular ejection fraction > 35%
at least one saphenous vein graft required as part of revascularization strategy
11 exclusion criteria prevent from participating
Acute or chronic inflammatory diseases
Coagulopathy
Insulin dependent diabetes mellitus
Leg not suitable for No-touch vein harvesting as judged by the operator
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Group II

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Institute for Circulation and Imaging

Trondheim, NorwayOpen Institute for Circulation and Imaging in Google Maps
SuspendedOne Study Center