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临床试验/NCT01510821
NCT01510821已完成不适用

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 University4 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2011年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
4
主要终点
SVG vascular contractility

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
21 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • patients undergoing any concomitant surgical procedures

结局指标

主要结局

SVG vascular contractility

时间窗: Day of surgery

次要结局

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

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Vinod Thourani

Associate Professor of Surgery

Emory University

研究点 (4)

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