Ischaemic PReconditioning In Non Cardiac surgEry
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.
Investigators
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