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ACTIVE NOT RECRUITING
NCT02427867
NA

Ischaemic PReconditioning In Non Cardiac surgEry

Sponsor: Università Vita-Salute San Raffaele

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

50 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1217

Start Date

2015-04

Completion Date

2025-12

Last Updated

2025-08-07

Healthy Volunteers

No

Interventions

OTHER

Remote ischemic preconditioning

OTHER

no ischemic preconditioning

Locations (26)

Xijing Hospital

Xi'an, China

Fundación Cardioinfantil-Instituto de Cardiología

Bogotá, Colombia

University Hospital Centre Zagreb

Zagreb, Croatia

Humanitas Clinical Institute

Rozzano, Lombardy, Italy

Valle Olona Po hospital

Busto Arsizio, Varese, Italy

Ospedale Cardinal Massaia

Asti, Italy

Azienda Ospedaliero Universitaria Careggi

Florence, Italy

E.O. Ospedali Galliera

Genova, Italy

IRCCS San Raffaele Scientific Institute

Milan, Italy

Fondazione IRCCS. Istituto Neurologico Carlo Besta

Milan, Italy

Università degli studi della Campania Luigi Vanvitelli

Naples, Italy

Azienda Universitaria Ospedaliero Pisana

Pisa, Italy

A.O.U. 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

Astana Medical University

Astana, Kazakhstan

Loginov Moscow Clinical Scientific Center

Moscow, Russia

Oncological Center No. 1 of the S. S. Yudin City Clinical Hospital of the Moscow Department of Health

Moscow, Russia

I.M. Sechenov First Moscow State Medical

Moscow, Russia

V.Negovsky Reanimatolgy Research Institute

Moscow, Russia

Saint-Petersburg State University Hospital

Saint Petersburg, Russia

Institute of Cardiovascular Diseases "Dedinje"

Belgrade, Serbia

National University Hospital

Singapore, Singapore

Ospedale Regionale di Lugano

Lugano, Switzerland