Ignite Creation Date:
2025-12-25 @ 12:46 AM
Ignite Modification Date:
2026-02-23 @ 12:20 PM
Study NCT ID:
NCT02427867
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-07
First Post:
2015-04-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ischaemic PReconditioning In Non Cardiac surgEry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1217}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-05', 'studyFirstSubmitDate': '2015-04-15', 'studyFirstSubmitQcDate': '2015-04-22', 'lastUpdatePostDateStruct': {'date': '2025-08-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-04-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'cardiac troponin', 'timeFrame': 'Hospital - approximately 1 week', 'description': 'elevation of cardiac troponin after non-cardiac surgery'}]}, 'conditionsModule': {'keywords': ['remote ischemic preconditioning', 'non cardiac surgery', 'myocardial ischemia'], 'conditions': ['Myocardial Ischemia', 'Surgery']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', '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'}, {'pmid': '40511609', 'type': 'DERIVED', 'citation': "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."}, {'pmid': '36645250', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'Several randomized trials suggested a cardioprotective beneficial effect (eg reduction in cardiac troponin release) of remote ischemic preconditioning in cardiac surgery.\n\nRemote 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* written informed consent\n* intermedial and high risk non cardiac surgery\n* general anesthesia\n* ongoing or recently suspended antiplatelet therapy\n\nExclusion Criteria:\n\n* pregnancy\n* planned locoregional anesthesia without general anesthesia\n* unstable or ongoing angina\n* recent (\\< 1 month) or ongoing acute myocardial infarction\n* inclusion in other randomised controlled studies in the previous 30 days\n* peripheral vascular disease affecting the upper limbs\n* cardiac surgery'}, 'identificationModule': {'nctId': 'NCT02427867', 'acronym': 'PRINCE', 'briefTitle': 'Ischaemic PReconditioning In Non Cardiac surgEry', 'organization': {'class': 'OTHER', 'fullName': 'Università Vita-Salute San Raffaele'}, 'officialTitle': 'Ischaemic PReconditioning In Non Cardiac surgEry', 'orgStudyIdInfo': {'id': 'PRINCE/43/OSR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'remote ischemic preconditioning', 'description': '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.', 'interventionNames': ['Other: Remote ischemic preconditioning']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'no ischemic preconditioning', 'description': 'The cuff will be placed around the arm but not inflated.', 'interventionNames': ['Other: no ischemic preconditioning']}], 'interventions': [{'name': 'Remote ischemic preconditioning', 'type': 'OTHER', 'armGroupLabels': ['remote ischemic preconditioning']}, {'name': 'no ischemic preconditioning', 'type': 'OTHER', 'armGroupLabels': ['no ischemic preconditioning']}]}, 'contactsLocationsModule': {'locations': [{'zip': '710032', 'city': "Xi'an", 'country': 'China', 'facility': 'Xijing Hospital', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}, {'zip': '110131', 'city': 'Bogotá', 'country': 'Colombia', 'facility': 'Fundación Cardioinfantil-Instituto de Cardiología', 'geoPoint': {'lat': 4.60971, 'lon': -74.08175}}, {'zip': '10000', 'city': 'Zagreb', 'country': 'Croatia', 'facility': 'University Hospital Centre Zagreb', 'geoPoint': {'lat': 45.81444, 'lon': 15.97798}}, {'zip': '20100', 'city': 'Rozzano', 'state': 'Lombardy', 'country': 'Italy', 'facility': 'Humanitas Clinical Institute', 'geoPoint': {'lat': 45.38193, 'lon': 9.1559}}, {'city': 'Busto Arsizio', 'state': 'Varese', 'country': 'Italy', 'facility': 'Valle Olona Po hospital', 'geoPoint': {'lat': 45.61128, 'lon': 8.84914}}, {'zip': '14100', 'city': 'Asti', 'country': 'Italy', 'facility': 'Ospedale Cardinal Massaia', 'geoPoint': {'lat': 44.90162, 'lon': 8.20751}}, {'zip': '50139', 'city': 'Florence', 'country': 'Italy', 'facility': 'Azienda Ospedaliero Universitaria Careggi', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}, {'zip': '16128', 'city': 'Genova', 'country': 'Italy', 'facility': 'E.O. Ospedali Galliera', 'geoPoint': {'lat': 45.21604, 'lon': 11.87211}}, {'zip': '20132', 'city': 'Milan', 'country': 'Italy', 'facility': 'IRCCS San Raffaele Scientific Institute', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': '20133', 'city': 'Milan', 'country': 'Italy', 'facility': 'Fondazione IRCCS. Istituto Neurologico Carlo Besta', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': '80138', 'city': 'Napoli', 'country': 'Italy', 'facility': 'Università degli studi della Campania Luigi Vanvitelli', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'zip': '56100', 'city': 'Pisa', 'country': 'Italy', 'facility': 'Azienda Universitaria Ospedaliero Pisana', 'geoPoint': {'lat': 43.70853, 'lon': 10.4036}}, {'city': 'Pisa', 'country': 'Italy', 'facility': 'A.O.U. Pisana', 'geoPoint': {'lat': 43.70853, 'lon': 10.4036}}, {'zip': '00128', 'city': 'Rome', 'country': 'Italy', 'facility': 'Fondazione Policlinico Universitario Campus Bio-Medico di Roma', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'zip': '00136', 'city': 'Rome', 'country': 'Italy', 'facility': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'zip': '30027', 'city': 'San Donà di Piave', 'country': 'Italy', 'facility': 'ULSS 4 Veneto Orientale, Ospedale di San Donà di Piave', 'geoPoint': {'lat': 45.63019, 'lon': 12.5681}}, {'zip': '33100', 'city': 'Udine', 'country': 'Italy', 'facility': 'Azienda Sanitaria Universitaria Friuli Centrale "Santa Maria della Misericordia"', 'geoPoint': {'lat': 46.0693, 'lon': 13.23715}}, {'zip': '010000', 'city': 'Astana', 'country': 'Kazakhstan', 'facility': 'Astana Medical University', 'geoPoint': {'lat': 51.1801, 'lon': 71.44598}}, {'zip': '111123', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Loginov Moscow Clinical Scientific Center', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '117152', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Oncological Center No. 1 of the S. S. Yudin City Clinical Hospital of the Moscow Department of Health', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Moscow', 'country': 'Russia', 'facility': 'I.M. Sechenov First Moscow State Medical', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Moscow', 'country': 'Russia', 'facility': 'V.Negovsky Reanimatolgy Research Institute', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Saint-Petersburg State University Hospital', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'city': 'Belgrade', 'country': 'Serbia', 'facility': 'Institute of Cardiovascular Diseases "Dedinje"', 'geoPoint': {'lat': 44.80401, 'lon': 20.46513}}, {'zip': '119074', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'National University Hospital', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'city': 'Lugano', 'country': 'Switzerland', 'facility': 'Ospedale Regionale di Lugano', 'geoPoint': {'lat': 46.01008, 'lon': 8.96004}}], 'overallOfficials': [{'name': 'Alberto Zangrillo, Prof.', 'role': 'STUDY_CHAIR', 'affiliation': 'Vita-Salute University of Milan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Università Vita-Salute San Raffaele', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, Associate Professor', 'investigatorFullName': 'Giovanni Landoni', 'investigatorAffiliation': 'Università Vita-Salute San Raffaele'}}}}