Investigation of Endothelium in Saphenous Vein Grafts

Not Applicable

Completed

• Conditions: Endothelial Function of Saphenous Vein Grafts
• Interventions: Other: Use of Maquet Vasoshield Pressure-limiting syringe on SVG; Other: Use of non-regulated syringe on SVG

• Registration Number: NCT01510821
• Lead Sponsor: Emory University

Brief Summary

This is a single center prospective study of 30 patients undergoing elective heart bypass surgery (CABG) with at least two vein grafts from the leg (SVG). The purpose of this ex vivo study is to evaluate the function of vein grafts from small tissue samples treated with a pressure syringe and a non-pressure syringe. Syringes are routinely used to flush out the veins in preparation of bypass grafting. It is unknown if different levels of pressure in the syringe affect the vein or damage the vein. Small sections of tissue samples which are normally discarded will be obtained immediately after retrieval from the leg and before grafting to the heart. Tissue samples will be taken to the laboratory for study. There are no clinical endpoints in this study, however, clinical information will be obtained from the Society of Thoracic Surgeons database and will include demographics, risk factors, and perioperative outcomes.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2011-11-02
• Study First Submitted QC: 2012-01-14
• Study First Posted: 2012-01-18
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-30
• Last Update Posted: 2013-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• patients undergoing elective coronary artery bypass graft surgery requiring at least 2 saphenous vein grafts

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Exclusion Criteria

• patients undergoing any concomitant surgical procedures

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Maquet Vasoshield Arm	Use of Maquet Vasoshield Pressure-limiting syringe on SVG	Pressure limiting syringe
Non-regulated Arm	Use of non-regulated syringe on SVG	standard non-regulated syringe

Primary Outcome Measures

Name	Time	Method
SVG vascular contractility	Day of surgery

Secondary Outcome Measures

Name	Time	Method
Nitric oxide metabolite levels	Day of surgery
Major adverse cardiac events	6 months and 1 year

Trial Locations

Locations (2)

Cardiothoracic Surgery Research Laboratory; 🇺🇸 Atlanta, Georgia, United States

Emory University Hospital Midtown; 🇺🇸 Atlanta, Georgia, United States