Ischaemic PReconditioning In Non Cardiac surgEry (PRINCE)

  • STATUS
    Recruiting
  • End date
    Jun 15, 2023
  • participants needed
    1100
  • sponsor
    Università Vita-Salute San Raffaele
Updated on 15 July 2022
anesthesia
propofol
troponin
antiplatelet therapy
ischemia
cardiac troponin
heart surgery
coronary disease
cardiovascular complications

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.

Details
Condition Myocardial Ischemia, Surgery
Treatment Remote ischemic preconditioning, no ischemic preconditioning
Clinical Study IdentifierNCT02427867
SponsorUniversità Vita-Salute San Raffaele
Last Modified on15 July 2022

Eligibility

Yes No Not Sure

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
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