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临床试验/NCT02471456
NCT02471456已完成不适用

Major Adverse Cardiac and Cerebrovascular Event (MACCE) & Patients' Quality of Life (QOL) After Endoscopic Vein Harvesting as Compared to Open Vein Harvest for Coronary Artery Bypass Grafting

The Royal Wolverhampton Hospitals NHS Trust1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2015年7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
100
试验地点
1
主要终点
MACCE in patients undergoing CABG where the LSV is harvested by EVH as compared to OVH

研究概览

简要总结

Most patients undergoing coronary artery bypass grafting (CABG) will require long saphenous vein (LSV) harvesting from the leg. This has been reported to be associated with a significant morbidity (leg swelling, pain, infection, bruising, wound discharge) in up to 50% of patients. Endoscopic vein harvesting (EVH) which has been reported to be associated with a reduction in these complications was implemented within the investigators' service in 2012. Although some initial reports of concerns regarding graft patency when the LSV is harvested by EVH, NICE and European Cardiology Society (ESC/EACTS) guidelines 2014 supported the use of the EVH technology. Last year a service evaluation in the investigators' department showed significant cost benefit of EVH as compared to open vein harvest (OVH) in a matched group (50 EVH and 50 OVH patients). The purpose of this study is to evaluate this group further to assess the incidence of MACCE (Major adverse cardiac and cerebrovascular event) and patient's quality of life (QOL) at least 1 year after their surgery. MACCE will be assessed by contacting the patient's GP and/or Cardiologist and QOL questionnaire (SF12v2) will be sent to patients along with a patient information sheet. It is estimated that data collection would be completed within 3 months of start.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
40 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient underwent CABG (isolated or combined) during period Jan 2012 to Dec 2013
  • LSV harvested by EVH (Study group)
  • LSV Harvested by OVH matched with EVH group (Control group)

排除标准

  • Patient deceased at time of study start

结局指标

主要结局

MACCE in patients undergoing CABG where the LSV is harvested by EVH as compared to OVH

时间窗: approximately 1 year

The review of MACCE will occur at least 1 year after the patient's operation

次要结局

  • Time taken to return to regular daily activities(approximately 1 year)
  • Survival(at approximately 1 year)
  • QOL as assessed by the SF12v2 questionnaire(approximately 1 year)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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