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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| remote ischemic preconditioning | Experimental | 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 | Placebo Comparator | The cuff will be placed around the arm but not inflated. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remote ischemic preconditioning | Other |
| ||
| no ischemic preconditioning |
| Measure | Description | Time Frame |
|---|---|---|
| cardiac troponin | elevation of cardiac troponin after non-cardiac surgery | Hospital - approximately 1 week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alberto Zangrillo, Prof. | Vita-Salute University of Milan | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xijing Hospital | Xi'an | 710032 | China | |||
| Fundación Cardioinfantil-Instituto de Cardiología |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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 | ||
| 40511609 | Derived | Greco M, Lombardi G, Brusasco C, Pieri M, Roasio A, Monaco F, Berikashvili L, Belletti A, Meroi F, Fresilli S, Kabibulatov A, Giardina G, Russo A, Oliva FM, Efremov S, Lembo R, Wang L, Vietri S, Momesso E, D'Amico F, Kadantseva K, Labanca R, Ryzhkov P, Marmiere M, Subbotin V, Pruna A, Rana N, Livi F, Mantilla-Gutierrez H, Guarracino F, Schiavoni L, Situm I, Micali M, Bosso S, Smirnova A, Fresta G, Cherednichenko A, Beretta L, Monti G, Ti LK, Sansone P, Corradi F, Cecconi M, Yavorovskiy A, Lei C, Konkayev A, Bove T, Likhvantsev V, Zangrillo A, Landoni G, Bellomo R, Covello RD, Turi S; PRINCE Study Group. Effect of Remote Ischemic Preconditioning on Myocardial Injury in Noncardiac Surgery: The PRINCE Randomized Clinical Trial. Circulation. 2025 Oct 28;152(17):1194-1205. doi: 10.1161/CIRCULATIONAHA.125.075254. Epub 2025 Jun 13. |
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| Other |
|
| Bogotá |
| 110131 |
| Colombia |
| University Hospital Centre Zagreb | Zagreb | 10000 | Croatia |
| Humanitas Clinical Institute | Rozzano | Lombardy | 20100 | Italy |
| Valle Olona Po hospital | Busto Arsizio | Varese | Italy |
| Ospedale Cardinal Massaia | Asti | 14100 | Italy |
| Azienda Ospedaliero Universitaria Careggi | Florence | 50139 | Italy |
| E.O. Ospedali Galliera | Genova | 16128 | Italy |
| IRCCS San Raffaele Scientific Institute | Milan | 20132 | Italy |
| Fondazione IRCCS. Istituto Neurologico Carlo Besta | Milan | 20133 | Italy |
| Università degli studi della Campania Luigi Vanvitelli | Naples | 80138 | Italy |
| Azienda Universitaria Ospedaliero Pisana | Pisa | 56100 | Italy |
| A.O.U. Pisana | Pisa | Italy |
| Fondazione Policlinico Universitario Campus Bio-Medico di Roma | Rome | 00128 | Italy |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Rome | 00136 | Italy |
| ULSS 4 Veneto Orientale, Ospedale di San Donà di Piave | San Donà di Piave | 30027 | Italy |
| Azienda Sanitaria Universitaria Friuli Centrale "Santa Maria della Misericordia" | Udine | 33100 | Italy |
| Astana Medical University | Astana | 010000 | Kazakhstan |
| Loginov Moscow Clinical Scientific Center | Moscow | 111123 | Russia |
| Oncological Center No. 1 of the S. S. Yudin City Clinical Hospital of the Moscow Department of Health | Moscow | 117152 | 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 | 119074 | Singapore |
| Ospedale Regionale di Lugano | Lugano | Switzerland |
| 36645250 | Derived | Liang F, Liu S, Liu G, Liu H, Wang Q, Song B, Yao L. Remote ischaemic preconditioning versus no remote ischaemic preconditioning for vascular and endovascular surgical procedures. Cochrane Database Syst Rev. 2023 Jan 16;1(1):CD008472. doi: 10.1002/14651858.CD008472.pub3. |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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