Ischaemic PReconditioning in Non Cardiac SurgEry

Not Applicable

Active, not recruiting

• Conditions: Surgery; Myocardial Ischemia
• Interventions: Other: Remote ischemic preconditioning; Other: no ischemic preconditioning

• Registration Number: NCT02427867
• Lead Sponsor: Università Vita-Salute San Raffaele

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-04-15
• Study First Submitted QC: 2015-04-22
• Study First Posted: 2015-04-28
• Status Verified: 2025-01
• Primary Completion: 2025-01
• Last Update Submitted: 2025-01-28
• Last Update Posted: 2025-01-31
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1217

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
remote ischemic preconditioning	Remote ischemic preconditioning	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.
no ischemic preconditioning	no ischemic preconditioning	The cuff will be placed around the arm but not inflated.

Primary Outcome Measures

Name	Time	Method
cardiac troponin	Hospital - approximately 1 week	elevation of cardiac troponin after non-cardiac surgery

Trial Locations

Locations (25)

Astana Medical University; 🇰🇿 Astana, Kazakhstan

Loginov Moscow Clinical Scientific Center; 🇷🇺 Moscow, Russia, Russian Federation

Xijing Hospital; 🇨🇳 Xi'an, China

Fundación Cardioinfantil-Instituto de Cardiología; 🇨🇴 Bogotà, Colombia

University Hospital Centre Zagreb; 🇭🇷 Zagreb, Croatia

Ospedale Cardinal Massaia; 🇮🇹 Asti, Italy

Azienda Ospedaliero Universitaria Careggi; 🇮🇹 Firenze, Italy

E.O. Ospedali Galliera; 🇮🇹 Genova, Italy

Fondazione IRCCS. Istituto Neurologico Carlo Besta; 🇮🇹 Milan, Italy

Università degli studi della Campania Luigi Vanvitelli; 🇮🇹 Napoli, Italy

Azienda Universitaria Ospedaliero Pisana; 🇮🇹 Pisa, Italy

Fondazione Policlinico Universitario Campus Bio-Medico di Roma; 🇮🇹 Rome, Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS; 🇮🇹 Rome, Italy

ULSS 4 Veneto Orientale, Ospedale di San Donà di Piave; 🇮🇹 San Donà di Piave, Italy

Azienda Sanitaria Universitaria Friuli Centrale "Santa Maria della Misericordia"; 🇮🇹 Udine, Italy

Oncological Center No. 1 of the S. S. Yudin City Clinical Hospital of the Moscow Department of Health; 🇷🇺 Moscow, Russia, Russian Federation

National University Hospital; 🇸🇬 Singapore, Singapore

Ospedale Regionale di Lugano; 🇨🇭 Lugano, Switzerland

Humanitas Clinical Institute; 🇮🇹 Rozzano, Lombardy, Italy

Valle Olona Po hospital; 🇮🇹 Busto Arsizio, Varese, Italy

IRCCS San Raffaele Scientific Institute; 🇮🇹 Milan, Italy

I.M. Sechenov First Moscow State Medical; 🇷🇺 Moscow, Russian Federation

V.Negovsky Reanimatolgy Research Institute; 🇷🇺 Moscow, Russian Federation

Saint-Petersburg State University Hospital; 🇷🇺 Saint Petersburg, Russian Federation

Institute of Cardiovascular Diseases "Dedinje"; 🇷🇸 Belgrade, Serbia