Ignite Creation Date:
2025-12-24 @ 10:09 PM
Ignite Modification Date:
2025-12-25 @ 7:45 PM
Study NCT ID:
NCT04630535
Status:
RECRUITING
Last Update Posted:
2025-05-15
First Post:
2020-11-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
OSA as a Remote Ischemic Preconditioning in Vascular Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}, {'id': 'D015427', 'term': 'Reperfusion Injury'}], 'ancestors': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'frozen blood plasma'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-12', 'studyFirstSubmitDate': '2020-11-04', 'studyFirstSubmitQcDate': '2020-11-13', 'lastUpdatePostDateStruct': {'date': '2025-05-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of I/R injury markers', 'timeFrame': 'T0 - before anesthesia induction; T1 - 3 hrs after aorta de-clamping; T2 - 12 hrs after aorta de-clamping; T3 - 24 hrs after aorta de-clamping; T4 - on the fifth post-operative day', 'description': 'Plasma Total Antioxidant Capacity and Reactive Oxygen Species Concentration'}], 'secondaryOutcomes': [{'measure': 'post-operative complications', 'timeFrame': 'up to 30 post-operative days', 'description': 'cardiovascular and pulmonary post-operative complications'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['remote preconditioning'], 'conditions': ['Obstructive Sleep Apnea', 'Vascular Aneurysm', 'Ischemia Reperfusion Injury']}, 'referencesModule': {'references': [{'pmid': '26798637', 'type': 'BACKGROUND', 'citation': 'Katseni K, Chalkias A, Kotsis T, Dafnios N, Arapoglou V, Kaparos G, Logothetis E, Iacovidou N, Karvouni E, Katsenis K. The Effect of Perioperative Ischemia and Reperfusion on Multiorgan Dysfunction following Abdominal Aortic Aneurysm Repair. Biomed Res Int. 2015;2015:598980. doi: 10.1155/2015/598980. Epub 2015 Dec 21.'}, {'pmid': '3769170', 'type': 'BACKGROUND', 'citation': 'Murry CE, Jennings RB, Reimer KA. Preconditioning with ischemia: a delay of lethal cell injury in ischemic myocardium. Circulation. 1986 Nov;74(5):1124-36. doi: 10.1161/01.cir.74.5.1124.'}, {'pmid': '19995115', 'type': 'BACKGROUND', 'citation': 'Walsh SR, Boyle JR, Tang TY, Sadat U, Cooper DG, Lapsley M, Norden AG, Varty K, Hayes PD, Gaunt ME. Remote ischemic preconditioning for renal and cardiac protection during endovascular aneurysm repair: a randomized controlled trial. J Endovasc Ther. 2009 Dec;16(6):680-9. doi: 10.1583/09-2817.1.'}, {'pmid': '20484066', 'type': 'BACKGROUND', 'citation': 'Walsh SR, Sadat U, Boyle JR, Tang TY, Lapsley M, Norden AG, Gaunt ME. Remote ischemic preconditioning for renal protection during elective open infrarenal abdominal aortic aneurysm repair: randomized controlled trial. Vasc Endovascular Surg. 2010 Jul;44(5):334-40. doi: 10.1177/1538574410370788. Epub 2010 May 18.'}, {'pmid': '23353795', 'type': 'BACKGROUND', 'citation': 'Li C, Li YS, Xu M, Wen SH, Yao X, Wu Y, Huang CY, Huang WQ, Liu KX. Limb remote ischemic preconditioning for intestinal and pulmonary protection during elective open infrarenal abdominal aortic aneurysm repair: a randomized controlled trial. Anesthesiology. 2013 Apr;118(4):842-52. doi: 10.1097/ALN.0b013e3182850da5.'}, {'pmid': '25281045', 'type': 'BACKGROUND', 'citation': "Murphy N, Vijayan A, Frohlich S, O'Farrell F, Barry M, Sheehan S, Boylan J, Conlon N. Remote ischemic preconditioning does not affect the incidence of acute kidney injury after elective abdominal aortic aneurysm repair. J Cardiothorac Vasc Anesth. 2014 Oct;28(5):1285-92. doi: 10.1053/j.jvca.2014.04.018."}, {'pmid': '26574485', 'type': 'BACKGROUND', 'citation': "Healy DA, Boyle E, McCartan D, Bourke M, Medani M, Ferguson J, Yagoub H, Bashar K, O'Donnell M, Newell J, Canning C, McMonagle M, Dowdall J, Cross S, O'Daly S, Manning B, Fulton G, Kavanagh EG, Burke P, Grace PA, Moloney MC, Walsh SR; Preconditioning Shields Against Vascular Events in Surgery (Preconditioning SAVES) Trial Group. A MultiCenter Pilot Randomized Controlled Trial of Remote Ischemic Preconditioning in Major Vascular Surgery. Vasc Endovascular Surg. 2015 Nov;49(8):220-7. doi: 10.1177/1538574415614404. Epub 2015 Nov 16."}, {'pmid': '27688236', 'type': 'BACKGROUND', 'citation': 'Garcia S, Rector TS, Zakharova M, Herrmann RR, Adabag S, Bertog S, Sandoval Y, Santilli S, Brilakis ES, McFalls EO. Cardiac Remote Ischemic Preconditioning Prior to Elective Vascular Surgery (CRIPES): A Prospective, Randomized, Sham-Controlled Phase II Clinical Trial. J Am Heart Assoc. 2016 Sep 29;5(10):e003916. doi: 10.1161/JAHA.116.003916.'}, {'pmid': '27075990', 'type': 'BACKGROUND', 'citation': 'Thomas KN, Cotter JD, Williams MJ, van Rij AM. Repeated Episodes of Remote Ischemic Preconditioning for the Prevention of Myocardial Injury in Vascular Surgery. Vasc Endovascular Surg. 2016 Apr;50(3):140-6. doi: 10.1177/1538574416639150. Epub 2016 Apr 12.'}, {'pmid': '26303818', 'type': 'BACKGROUND', 'citation': 'Mouton R, Pollock J, Soar J, Mitchell DC, Rogers CA. Remote ischaemic preconditioning versus sham procedure for abdominal aortic aneurysm repair: an external feasibility randomized controlled trial. Trials. 2015 Aug 25;16:377. doi: 10.1186/s13063-015-0899-3.'}, {'pmid': '30691816', 'type': 'BACKGROUND', 'citation': 'De Freitas S, Hicks CW, Mouton R, Garcia S, Healy D, Connolly C, Thomas KN, Walsh SR. Effects of Ischemic Preconditioning on Abdominal Aortic Aneurysm Repair: A Systematic Review and Meta-analysis. J Surg Res. 2019 Mar;235:340-349. doi: 10.1016/j.jss.2018.09.049. Epub 2018 Nov 13.'}, {'pmid': '28736306', 'type': 'BACKGROUND', 'citation': 'Sanchez-de-la-Torre A, Soler X, Barbe F, Flores M, Maisel A, Malhotra A, Rue M, Bertran S, Aldoma A, Worner F, Valls J, Lee CH, Turino C, Galera E, de Batlle J, Sanchez-de-la-Torre M; Spanish Sleep Network( *). Cardiac Troponin Values in Patients With Acute Coronary Syndrome and Sleep Apnea: A Pilot Study. Chest. 2018 Feb;153(2):329-338. doi: 10.1016/j.chest.2017.06.046. Epub 2017 Jul 20.'}, {'pmid': '23090861', 'type': 'BACKGROUND', 'citation': 'Shah N, Redline S, Yaggi HK, Wu R, Zhao CG, Ostfeld R, Menegus M, Tracy D, Brush E, Appel WD, Kaplan RC. Obstructive sleep apnea and acute myocardial infarction severity: ischemic preconditioning? Sleep Breath. 2013 May;17(2):819-26. doi: 10.1007/s11325-012-0770-7. Epub 2012 Oct 23.'}]}, 'descriptionModule': {'briefSummary': 'Ischemia and reperfusion (I/R) injury during abdominal aortic aneurysm (AAA) repair is inevitable and may lead to postoperative multi-organ failure. Remote ischemic preconditioning (short periods of ischemia in anticipation of longer period of ischemia) may act protectively against ischemia.\n\nStudies of ischemic preconditioning in patients with AAA are conflicting. Obstructive sleep apnea (OSA) is a sleep disordered breathing syndrome which may have a protective effect against ischemia.\n\nThe investigators hypothesize that I/R injury will be less pronounced in patients who have OSA and that the extent of I/R injury will inversely correlate with OSA severity. Accordingly, the aim of this study is to compare postoperative complications and markers of I/R in patients undergoing elective AAA repair who do and do not have OSA.', 'detailedDescription': 'Patients. Consecutive patients scheduled for elective aortobifemoral bypass (AAA and Leriche syndrome patients) will be recruited for this prospective, observational study.\n\nPolygraphy (PG). PG measurements will be done two nights before surgery using the Embletta system (Embla - Embletta MPR PG Sleep Data Recording System).\n\nSTOP-BANG, Epworth questionnaire. Both questionnaires will be done the same day as polygraphy\n\nCardiovascular complications will be assessed from the first 30 post-operative days Pulmonary complications will be assessed from the first 30 post-operative days\n\nSpecific markers of I/R. T0 - before anesthesia induction T1 - 3 hrs after aorta de-clamping T2 - 12 hrs after aorta de-clamping T3 - 24 hrs after aorta de-clamping T4 - on the fifth post-operative day'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'consecutive patients scheduled for elective aorto-bifemoral bypass (AAA and Leriche syndrome patients)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients scheduled for elective aorto-bifemoral bypass (AAA and Leriche syndrome patients)\n\nExclusion Criteria:\n\n* emergent surgery\n* aorto-bifemoral bypass using deep vein graft\n* re-operations\n* known OSA with CPAP treatment'}, 'identificationModule': {'nctId': 'NCT04630535', 'briefTitle': 'OSA as a Remote Ischemic Preconditioning in Vascular Surgery', 'organization': {'class': 'OTHER', 'fullName': "St. Anne's University Hospital Brno, Czech Republic"}, 'officialTitle': 'Obstructive Sleep Apnea as a Remote Ischemic Preconditioning in Patients Scheduled for Aorto-bifemoral Bypass Surgery', 'orgStudyIdInfo': {'id': 'IIT/2019/25'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Obstructive Sleep Apnea', 'description': 'Pacient with OSA (AHIā„5) undergoing aorto-bifemoral bypass', 'interventionNames': ['Procedure: aorto-bifemoral bypass surgery']}, {'label': 'Without Obstructive Sleep Apnea', 'description': 'Patinets without OSA undergoing aorto-bifemoral bypass', 'interventionNames': ['Procedure: aorto-bifemoral bypass surgery']}], 'interventions': [{'name': 'aorto-bifemoral bypass surgery', 'type': 'PROCEDURE', 'description': 'aorto-bifemoral bypass surgery (Leriche syndrom, elective AAA repair)', 'armGroupLabels': ['Obstructive Sleep Apnea', 'Without Obstructive Sleep Apnea']}]}, 'contactsLocationsModule': {'locations': [{'zip': '65691', 'city': 'Brno', 'state': 'Czech Republic', 'status': 'RECRUITING', 'country': 'Czechia', 'contacts': [{'name': 'Ivan Cundrle, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'ivan.cundrle@fnusa.cz', 'phone': '00420543182553'}, {'name': 'Marek Lukes, M.D.', 'role': 'CONTACT', 'email': 'marek.lukes@fnusa.cz', 'phone': '00420543182553'}, {'name': 'Ivan Cundrle, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Lukas Ruzek, M.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Marek Lukes, M.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ondrej Ludka, MD., Ph.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Tomas Novotny, M.D., Ph.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ludmila Tusinovska, M.D.', 'role': 'SUB_INVESTIGATOR'}], 'facility': "St. Anne's University Hospital Brno", 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}], 'centralContacts': [{'name': 'Ivan Cundrle, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'ivan.cundrle@fnusa.cz', 'phone': '00420543182553'}, {'name': 'Marek Lukes, M.D.', 'role': 'CONTACT', 'email': 'marek.lukes@fnusa.cz', 'phone': '00420543182553'}], 'overallOfficials': [{'name': 'Ivan Cundrle, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "St. Anne's University Hospital in Brno"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "St. Anne's University Hospital Brno, Czech Republic", 'class': 'OTHER'}, 'collaborators': [{'name': 'Masaryk University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ivan Cundrle', 'investigatorAffiliation': "St. Anne's University Hospital Brno, Czech Republic"}}}}