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临床试验/NCT02427867
NCT02427867进行中(未招募)不适用

Ischaemic PReconditioning In Non Cardiac surgEry

Università Vita-Salute San Raffaele55 个研究点 分布在 9 个国家目标入组 1,217 人开始时间: 2015年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
1,217
试验地点
55
主要终点
cardiac troponin

研究概览

简要总结

Several randomized trials suggested a cardioprotective beneficial effect (eg reduction in cardiac troponin release) of remote ischemic preconditioning in cardiac surgery.

Remote ischemic preconditioning by brief episodes of ischemia and reperfusion in a remote organ or vascular territory provides protection from injury by myocardial ischemia and reperfusion. In the translation of remote ischemic preconditioning from bench to bedside, the first proof of principle and small randomized controlled trials have shown a decreased release of myocardial biomarkers after aortic, congenital cardiac, adult valve and coronary artery by-pass graft surgery. This reduction in cardiac biomarkers release translated into better survival in a recent randomized trial performed in cardiac surgery. No clinical trial on remote ischemic preconditioning in non-cardiac surgery setting has been performed so far.

The investigators study wants to test, for the first time, the hypothesis that remote ischaemic preconditioning is effective in reducing cardiac damage in high risk patients undergoing non-cardiac surgery. Remote ischaemic preconditioning will be achieved by inflation of a blood-pressure cuff to 200 mm Hg to the upper arm for 5 minutes, followed by 5 minutes reperfusion while the cuff will be deflated. General anesthesia will be induced and maintained without using propofol in both groups. Cardiac troponin will be used as marker of cardiac damage. If the results of a reduction in postoperative cardiac troponin release and perioperative cardiac ischaemic events will be confirmed in a non-cardiac surgery setting, the investigators could improve a strategy to prevent perioperative cardiac complication easy to apply, safe and low cost.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • written informed consent
  • intermedial and high risk non cardiac surgery
  • general anesthesia
  • ongoing or recently suspended antiplatelet therapy

排除标准

  • pregnancy
  • planned locoregional anesthesia without general anesthesia
  • unstable or ongoing angina
  • recent (< 1 month) or ongoing acute myocardial infarction
  • inclusion in other randomised controlled studies in the previous 30 days
  • peripheral vascular disease affecting the upper limbs
  • cardiac surgery

研究组 & 干预措施

remote ischemic preconditioning

Experimental

Three cycles of 5 minutes ischemia will be applied to the upper left arm (or right arm or legs if the left arm will not be deemed suitable by the attending physician), achieved by inflation of a blood-pressure cuff to 200 mm Hg, followed by 5 minutes reperfusion while the cuff will be deflated.

干预措施: Remote ischemic preconditioning (Other)

no ischemic preconditioning

Placebo Comparator

The cuff will be placed around the arm but not inflated.

干预措施: no ischemic preconditioning (Other)

结局指标

主要结局

cardiac troponin

时间窗: Hospital - approximately 1 week

elevation of cardiac troponin after non-cardiac surgery

次要结局

未报告次要终点

研究者

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

Giovanni Landoni

MD, Associate Professor

Università Vita-Salute San Raffaele

研究点 (55)

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