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Clinical Trials/NCT02427867
NCT02427867
Active, not recruiting
Not Applicable

Ischaemic PReconditioning In Non Cardiac surgEry

Università Vita-Salute San Raffaele26 sites in 9 countries1,217 target enrollmentApril 1, 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Myocardial Ischemia
Sponsor
Università Vita-Salute San Raffaele
Enrollment
1217
Locations
26
Primary Endpoint
cardiac troponin
Status
Active, not recruiting
Last Updated
8 months ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2015
End Date
December 1, 2025
Last Updated
8 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Giovanni Landoni

MD, Associate Professor

Università Vita-Salute San Raffaele

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

cardiac troponin

Time Frame: Hospital - approximately 1 week

elevation of cardiac troponin after non-cardiac surgery

Study Sites (26)

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