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

NCT ID: NCT01834846

Last Updated: 2021-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2021-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Myocardial Ischemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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no-touch

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

Group Type EXPERIMENTAL

no-touch

Intervention Type PROCEDURE

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

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

Group Type ACTIVE_COMPARATOR

conventional

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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St. Olavs Hospital

OTHER

Sponsor Role collaborator

Norwegian University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dag Ole Nordhaug, md phd

Role: PRINCIPAL_INVESTIGATOR

Norwegian University of Science and Technology

Locations

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Institute for Circulation and Imaging

Trondheim, Sør-Trøndelag, Norway

Site Status

Countries

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Norway

References

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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.

Reference Type RESULT
PMID: 27443441 (View on PubMed)

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.

Reference Type RESULT
PMID: 28648540 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30444258 (View on PubMed)

Other Identifiers

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090486

Identifier Type: -

Identifier Source: org_study_id

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