Investigation of Endothelium in Saphenous Vein Grafts

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective Trial to Investigate Endothelial Dysfunction in Saphenous Vein Grafts Subjected to the Maquet Vasoshield Pressure Limiting Syringe Versus Non-Regulated Vessel Dilation in Patients Undergoing Coronary Artery Bypass Grafting

Conditions
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Endothelial Function of Saphenous Vein Grafts

Intervention / Treatment
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* Other: Use of Maquet Vasoshield Pressure-limiting syringe on SVG
* Other: Use of non-regulated syringe on SVG


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients undergoing elective coronary artery bypass graft surgery requiring at least 2 saphenous vein grafts Exclusion Criteria: patients undergoing any concomitant surgical procedures

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Maquet Vasoshield Arm<br>Pressure limiting syringe | Other: Use of Maquet Vasoshield Pressure-limiting syringe on SVG<br>* Use of Maquet Vasoshield Pressure-limiting syringe on SVG<br>* Other names: Maquet device;|
| Active Comparator: Non-regulated Arm<br>standard non-regulated syringe | Other: Use of non-regulated syringe on SVG<br>* Use of non-regulated syringe on SVG<br>* Other names: standard syringe;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SVG vascular contractility |  | Day of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nitric oxide metabolite levels |  | Day of surgery | 
| Major adverse cardiac events |  | 6 months and 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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endoscopic vein harvest, saphenous vein graft, endothelial function