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Clinical Trials/NCT01510821
NCT01510821
Completed
Not Applicable

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

Emory University2 sites in 1 country30 target enrollmentNovember 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Endothelial Function of Saphenous Vein Grafts
Sponsor
Emory University
Enrollment
30
Locations
2
Primary Endpoint
SVG vascular contractility
Status
Completed
Last Updated
12 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 2011
End Date
June 2012
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Vinod Thourani

Associate Professor of Surgery

Emory University

Eligibility Criteria

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

Outcomes

Primary Outcomes

SVG vascular contractility

Time Frame: Day of surgery

Secondary Outcomes

  • Nitric oxide metabolite levels(Day of surgery)
  • Major adverse cardiac events(6 months and 1 year)

Study Sites (2)

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