Clinical trial NCT02427867: Ischaemic PReconditioning In Non Cardiac surgEry
Official title: Ischaemic PReconditioning In Non Cardiac surgEry
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Myocardial Ischemia
Surgery
Keywords: remote ischemic preconditioning
non cardiac surgery
myocardial ischemia
Lead sponsor: Università Vita-Salute San Raffaele
Sponsor class: OTHER
First posted: 2015-04-28
Enrollment: 1217
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: cardiac troponin
timeFrame: Hospital - approximately 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hospital
city: Bogotà
country: Colombia
facility: Fundación Cardioinfantil-Instituto de Cardiología
city: Zagreb
country: Croatia
facility: University Hospital Centre Zagreb
city: Rozzano
country: Italy
facility: Humanitas Clinical Institute
state: Lombardy
city: Busto Arsizio
country: Italy
facility: Valle Olona Po hospital
state: Varese
city: Asti
country: Italy
facility: Ospedale Cardinal Massaia
city: Firenze
country: Italy
facility: Azienda Ospedaliero Universitaria Careggi
city: Genova
country: Italy
facility: E.O. Ospedali Galliera
city: Milan
country: Italy
facility: IRCCS San Raffaele Scientific Institute
city: Milan
country: Italy
facility: Fondazione IRCCS. Istituto Neurologico Carlo Besta
city: Napoli
country: Italy
facility: Università degli studi della Campania Luigi Vanvitelli
city: Pisa
country: Italy
facility: Azienda Universitaria Ospedaliero Pisana
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario Campus Bio-Medico di Roma
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
city: San Donà di Piave
country: Italy
facility: ULSS 4 Veneto Orientale, Ospedale di San Donà di Piave
city: Udine
country: Italy
facility: Azienda Sanitaria Universitaria Friuli Centrale "Santa Maria della Misericordia"
city: Astana
country: Kazakhstan
facility: Astana Medical University
city: Moscow
country: Russian Federation
facility: Loginov Moscow Clinical Scientific Center
state: Russia
city: Moscow
country: Russian Federation
facility: Oncological Center No. 1 of the S. S. Yudin City Clinical Hospital of the Moscow Department of Health
state: Russia
city: Moscow
country: Russian Federation
facility: I.M. Sechenov First Moscow State Medical
city: Moscow
country: Russian Federation
facility: V.Negovsky Reanimatolgy Research Institute
city: Saint Petersburg
country: Russian Federation
facility: Saint-Petersburg State University Hospital
city: Belgrade
country: Serbia
facility: Institute of Cardiovascular Diseases "Dedinje"
city: Singapore
country: Singapore
facility: National University Hospital
city: Lugano
country: Switzerland
facility: Ospedale Regionale di Lugano
Study officials:
affiliation: Vita-Salute University of Milan
name: Alberto Zangrillo, Prof.
role: STUDY_CHAIR
References:
citation: Massimiliano Greco, Gaetano Lombardi, Aidos Konkayev, Claudia Brusasco, Chong Lei, Agostino Roasio, Nerlep Rana, Hugo A. Mantilla-gutierrez, Marco Micali, Gordana Gazivoda, Michela Gandini, Lian Kah Ti, Stefano Bosso, Maiya Konkayeva, Francesco Meroi, Lini Wang, Andrea Russo, Sergey Efremov, Giuseppe Fresta, Levan Berikashvili, Francesca Livi, Ivan Šitum, Fabio Guarracino, Elizaveta Leonova, Francesca Cavenago, Maria Shemetova, Edoardo Cristallo, Anastasia Smirnova, Lorenzo Schiavoni, Valerii Subbotin, Nicoletta Boffa, Giuseppe Giardina, Michele Introna, Cristina Nakhnoukh, Remo Daniel Covello, Marina Pieri, Stefano Turi, Valentina Ajello, Fabrizio Monaco, Francesco Corradi, Andrey Yavorovskiy, Valery Likhvantsev, Federico Longhini, Tiziana Bove, Rinaldo Bellomo, Giovanni Landoni, Alberto Zangrillo, Rosalba Lembo. Remote ischemic preconditioning in non-cardiac surgery (PRINCE): a multinational, double blind, sham-controlled, randomized clinical trial. Signa Vitae. 2024. 20(12);1-9. https://www.signavitae.com/articles/10.22514/sv.2024.151