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Ischaemic PReconditioning In Non Cardiac surgEry
Sponsor: Università Vita-Salute San Raffaele
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
Conditions
Interventions
Remote ischemic preconditioning
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