Ischaemic PReconditioning In Non Cardiac surgEry (PRINCE)

Università Vita-Salute San Raffaele

Status: Active, not recruiting

Conditions: Myocardial Ischemia; Surgery

Treatments: Other: Remote ischemic preconditioning; Other: no ischemic preconditioning

Study type: Interventional

Funder types: Other

Identifiers

NCT02427867

PRINCE/43/OSR

Details and patient eligibility

About

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.

Enrollment: 1,217 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,217 participants in 2 patient groups, including a placebo group

remote ischemic preconditioning

Experimental group

Description:

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.

Treatment:

Other: Remote ischemic preconditioning

no ischemic preconditioning

Placebo Comparator group

Description:

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

Treatment:

Other: no ischemic preconditioning