Clinical trial NCT01834846: Impact of Perivascular Tissue on Endothelial Function in Coronary Artery Bypass Grafting
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
Overall status: UNKNOWN
Phase: NA
Conditions: Myocardial Ischemia
Keywords: comparative study
Cardiac Surgical Procedures
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
First posted: 2013-04-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Graft function
timeFrame: 6 months
measure: Graft function
timeFrame: 5 years
Secondary outcomes:
measure: Morphological appearance of vein graft
timeFrame: 6 months
measure: Morphological appearance of vein graft
timeFrame: 5 years
measure: Postoperative leg wound complications
timeFrame: 6 weeks
measure: Postoperative complications related to cardiac surgery
timeFrame: Discharge, 6 weeks, 6 months
measure: Postoperative complications related to cardiac surgery
timeFrame: 5 years
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Institute for Circulation and Imaging
state: Sør-Trøndelag
Study officials:
affiliation: Norwegian University of Science and Technology
name: Dag Ole Nordhaug, md phd
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.