Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2025-12-26 @ 2:42 AM
Study NCT ID:
NCT07048002
Status:
RECRUITING
Last Update Posted:
2025-11-24
First Post:
2025-06-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Interventions for Silent Brain Infarction and Perioperative Neurocognitive Disorders in Cardiovascular Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019965', 'term': 'Neurocognitive Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 912}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2028-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-19', 'studyFirstSubmitDate': '2025-06-12', 'studyFirstSubmitQcDate': '2025-06-24', 'lastUpdatePostDateStruct': {'date': '2025-11-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-07-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Length of stay (LOS) in intensive care unit (ICU)', 'timeFrame': 'Perioperative', 'description': 'Length of stay (LOS) in intensive care unit (ICU) postoperatively'}, {'measure': 'Length of stay (LOS) in hospital', 'timeFrame': 'Perioperative', 'description': 'Length of stay (LOS) in hospital postoperatively'}, {'measure': 'Hospitalization cost', 'timeFrame': 'Perioperative', 'description': 'Operative and postoperative hospitalization cost'}], 'primaryOutcomes': [{'measure': 'the 7-day incidence of new-onset silent brain infarction (SBI)', 'timeFrame': 'within 7 days postoperatively', 'description': 'New-onset silent brain infarction refers to newly developed cerebral infarctions detected on MRI, compared with the preoperative MRI, in the absence of any corresponding clinical symptoms of cerebral infarction.'}], 'secondaryOutcomes': [{'measure': 'Key Secondary Outcome: the 30-day incidence of perioperative neurocognitive disorders (PND)', 'timeFrame': 'within 30 days postoperatively', 'description': 'The incidence of 30-day PND includes the incidence of postoperative delirium in hospital and perioperative neurocognitive disorders within 30 days after surgery'}, {'measure': 'the 5-day incidence of postoperative delirium', 'timeFrame': 'within five days postoperatively', 'description': 'the incedence of delirium evaluated by CAM/CAM-ICU'}, {'measure': 'the 30-day incidence of new-onset overt stroke', 'timeFrame': 'within 30 days postoperatively', 'description': 'Postoperative new-onset overt stroke was defined as any new ischemic or hemorrhagic cerebrovascular event after surgery with focal or global neurological (motor, sensory or cognitive) dysfunction lasting at least 24 h. And a broadened stroke definition also including neurological dysfunction of \\<24 h duration with corresponding evidence of central nervous system hemorrhage or infarction (including pathological, imaging, or other objective evidence of cerebral, spinal cord or retinal focal ischemic injury in a defined vascular distribution).'}, {'measure': 'the 1-year incidence of new-onset overt stroke', 'timeFrame': 'within 1 year postoperatively', 'description': 'Postoperative new-onset overt stroke was defined as any new ischemic or hemorrhagic cerebrovascular event after surgery with focal or global neurological (motor, sensory or cognitive) dysfunction lasting at least 24 h. And a broadened stroke definition also including neurological dysfunction of \\<24 h duration with corresponding evidence of central nervous system hemorrhage or infarction (including pathological, imaging, or other objective evidence of cerebral, spinal cord or retinal focal ischemic injury in a defined vascular distribution).'}, {'measure': 'the 1-year incidence of perioperative neurocognitive disorders (PND)', 'timeFrame': 'within 1 year postoperatively', 'description': 'the incidence of perioperative neurocognitive disorders (PND)'}, {'measure': 'the 30-day composite incidence of major adverse events', 'timeFrame': 'within 30 days postoperatively', 'description': 'Major adverse events refer to renal insufficiency, myocardial infarction, pulmonary embolism, seizure and all-cause mortality.'}, {'measure': 'the 1-year composite incidence of major adverse events', 'timeFrame': 'within 1 year postoperatively', 'description': 'Major adverse events refer to renal insufficiency, myocardial infarction, pulmonary embolism, seizure and all-cause mortality.'}, {'measure': 'the 30-day incidence of transient ischemic attack (TIA)', 'timeFrame': 'within 30 days postoperatively', 'description': 'TIA is defined as focal arterial ischemia with transient symptoms (lasting \\<24 hours) and without evidence of infarction by pathology or imaging.'}, {'measure': 'the 1-year incidence of transient ischemic attack (TIA)', 'timeFrame': 'within 1 year postoperatively', 'description': 'TIA is defined as focal arterial ischemia with transient symptoms (lasting \\<24 hours) and without evidence of infarction by pathology or imaging.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Silent Brain Infarction', 'Neurocognitive Disorders', 'Cardiac Surgery', 'Neuroprotective']}, 'referencesModule': {'references': [{'pmid': '31056357', 'type': 'BACKGROUND', 'citation': 'Uysal S, Lin HM, Trinh M, Park CH, Reich DL. Optimizing cerebral oxygenation in cardiac surgery: A randomized controlled trial examining neurocognitive and perioperative outcomes. J Thorac Cardiovasc Surg. 2020 Mar;159(3):943-953.e3. doi: 10.1016/j.jtcvs.2019.03.036. Epub 2019 Mar 29.'}, {'pmid': '28974062', 'type': 'BACKGROUND', 'citation': "Maheshwari A, McCormick PJ, Sessler DI, Reich DL, You J, Mascha EJ, Castillo JG, Levin MA, Duncan AE. Prolonged concurrent hypotension and low bispectral index ('double low') are associated with mortality, serious complications, and prolonged hospitalization after cardiac surgery. Br J Anaesth. 2017 Jul 1;119(1):40-49. doi: 10.1093/bja/aex095."}, {'pmid': '36934980', 'type': 'BACKGROUND', 'citation': 'Descamps R, Amour J, Besnier E, Bougle A, Charbonneau H, Charvin M, Cholley B, Desebbe O, Fellahi JL, Frasca D, Labaste F, Lena D, Mahjoub Y, Mertes PM, Molliex S, Moury PH, Moussa MD, Oilleau JF, Ouattara A, Provenchere S, Rozec B, Parienti JJ, Fischer MO; OPTIPAM investigators. Perioperative individualized hemodynamic optimization according to baseline mean arterial pressure in cardiac surgery patients: Rationale and design of the OPTIPAM randomized trial. Am Heart J. 2023 Jul;261:10-20. doi: 10.1016/j.ahj.2023.03.005. Epub 2023 Mar 18.'}, {'pmid': '35804216', 'type': 'BACKGROUND', 'citation': 'Gerstenecker A, Norling AM, Jacob A, Lazar RM. Silent Brain Infarction, Delirium, and Cognition in Three Invasive Cardiovascular Procedures: a Systematic Review. Neuropsychol Rev. 2023 Jun;33(2):474-491. doi: 10.1007/s11065-022-09548-1. Epub 2022 Jul 8.'}, {'pmid': '11172175', 'type': 'BACKGROUND', 'citation': 'Newman MF, Kirchner JL, Phillips-Bute B, Gaver V, Grocott H, Jones RH, Mark DB, Reves JG, Blumenthal JA; Neurological Outcome Research Group and the Cardiothoracic Anesthesiology Research Endeavors Investigators. Longitudinal assessment of neurocognitive function after coronary-artery bypass surgery. N Engl J Med. 2001 Feb 8;344(6):395-402. doi: 10.1056/NEJM200102083440601.'}, {'pmid': '29771710', 'type': 'BACKGROUND', 'citation': 'Brown CH 4th, Probert J, Healy R, Parish M, Nomura Y, Yamaguchi A, Tian J, Zehr K, Mandal K, Kamath V, Neufeld KJ, Hogue CW. Cognitive Decline after Delirium in Patients Undergoing Cardiac Surgery. Anesthesiology. 2018 Sep;129(3):406-416. doi: 10.1097/ALN.0000000000002253.'}, {'pmid': '36503642', 'type': 'BACKGROUND', 'citation': 'Cheng C, Wan H, Cong P, Huang X, Wu T, He M, Zhang Q, Xiong L, Tian L. Targeting neuroinflammation as a preventive and therapeutic approach for perioperative neurocognitive disorders. J Neuroinflammation. 2022 Dec 12;19(1):297. doi: 10.1186/s12974-022-02656-y.'}, {'pmid': '31017035', 'type': 'BACKGROUND', 'citation': 'Indja B, Woldendorp K, Vallely MP, Grieve SM. Silent Brain Infarcts Following Cardiac Procedures: A Systematic Review and Meta-Analysis. J Am Heart Assoc. 2019 May 7;8(9):e010920. doi: 10.1161/JAHA.118.010920.'}, {'pmid': '12660385', 'type': 'BACKGROUND', 'citation': 'Vermeer SE, Prins ND, den Heijer T, Hofman A, Koudstaal PJ, Breteler MM. Silent brain infarcts and the risk of dementia and cognitive decline. N Engl J Med. 2003 Mar 27;348(13):1215-22. doi: 10.1056/NEJMoa022066.'}, {'pmid': '25012298', 'type': 'BACKGROUND', 'citation': 'Fanning JP, Wong AA, Fraser JF. The epidemiology of silent brain infarction: a systematic review of population-based cohorts. BMC Med. 2014 Jul 9;12:119. doi: 10.1186/s12916-014-0119-0.'}, {'pmid': '32199830', 'type': 'BACKGROUND', 'citation': "Sultan I, Bianco V, Kilic A, Jovin T, Jadhav A, Jankowitz B, Aranda-Michel E, D'angelo MP, Navid F, Wang Y, Thoma F, Gleason TG. Predictors and Outcomes of Ischemic Stroke After Cardiac Surgery. Ann Thorac Surg. 2020 Aug;110(2):448-456. doi: 10.1016/j.athoracsur.2020.02.025. Epub 2020 Mar 19."}]}, 'descriptionModule': {'briefSummary': 'the purpose of the study is to investigate whether a combined anesthetic targets bundle, known as the NeuroFirst strategy, focused on neurological protection, can reduce the incidence of silent brain infarction (SBI) and perioperative neurocognitive disorders (PND) in patients undergoing cardiac surgery. Additionally, the trial will assess the safety of this strategy.\n\nThe NeuroFirst target bundle incorporates multiple parameters, including mean arterial pressure (MAP), bispectral index (BIS), regional cerebral oxygen saturation (rSO2), and arterial inflow temperature during cardiopulmonary bypass.\n\nThe primary question this study seeks to answer is: Does the NeuroFirst strategy reduce the incidence of SBI and PND in cardiac surgery?\n\nTo address this, researchers will compare the NeuroFirst strategy with routine institutional practices based on published guidelines. Participants will be randomly assigned to either the NeuroFirst group or the routine care group. All participants will undergo magnetic resonance imaging (MRI), be assessed using the Confusion Assessment Method (CAM) and the Montreal Cognitive Assessment (MoCA), and be followed for up to one year postoperatively.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Male or female adult patients aged 60 years or older\n* Receiving elective cardiovascular surgery with cardiopulmonary bypass\n* Written Informed consent provided\n\nExclusion criteria:\n\n* Contraindication to MRI scanning\n* Not suitable for receiving interventions to achieve NeuroFirst target bundle\n* Unable to receive neuro-cognitive evaluation due to language, vision, or hearing impairments\n* Breastfeeding or pregnancy\n* Terminal illness with a life expectancy of less than 3 months\n* Mental or legal disability\n* current enrollment in other interventional study'}, 'identificationModule': {'nctId': 'NCT07048002', 'acronym': 'INSPIRE', 'briefTitle': 'Interventions for Silent Brain Infarction and Perioperative Neurocognitive Disorders in Cardiovascular Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Chinese Academy of Medical Sciences, Fuwai Hospital'}, 'officialTitle': 'Interventions for Silent Brain Infarction and Perioperative Neurocognitive Disorders in Cardiovascular Surgery (the INSPIRE Study)', 'orgStudyIdInfo': {'id': 'The INSPIRE study'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NeuroFirst target bundle', 'description': 'Management for NeuroFirst target bundle', 'interventionNames': ['Other: Managements for NeuroFirst target bundle']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Routine Management', 'description': 'Management for institutional routine in accordance with published guidelines', 'interventionNames': ['Other: Managements for institutional routine']}], 'interventions': [{'name': 'Managements for NeuroFirst target bundle', 'type': 'OTHER', 'description': 'In the intervention group, patient management aims to achieve the NeuroFirst target bundle, including 1) mean arterial pressure (MAP) 65-90 mmHg, 2) bispectral index (BIS) 40-60, 3) regional cerebral oxygen saturation (rSO2)≥ 60% , and 4) arterial inflow temperature \\<37 ℃ and rewarming rate \\< 0.5 ℃/min after exceeding 30℃ during CPB.\n\nTo achieve this target bundle, pharmacologic agents, fluid resuscitation, blood transfusion, and other therapeutic modalities will be utilized. These interventions are guided by comprehensive intraoperative monitoring, including conventional hemodynamic monitoring, invasive or non-invasive cardiac output and vascular resistance assessments.', 'armGroupLabels': ['NeuroFirst target bundle']}, {'name': 'Managements for institutional routine', 'type': 'OTHER', 'description': 'MAP, BIS, cerebral rSO2 and arterial inflow temperature during CPB rewarming, will be managed according to institutional routine in accordance with published guidelines.', 'armGroupLabels': ['Routine Management']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100020', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Changwei Wei, M.D.', 'role': 'CONTACT', 'email': 'wcw0025@sina.com', 'phone': '8610 85231330'}, {'name': 'Changwei Wei, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Beijing Chaoyang Hospital，Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100037', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jia Shi, M.D.', 'role': 'CONTACT', 'email': 'shijia@fuwai.com', 'phone': '86 10 88322467'}, {'name': 'Jia Shi, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences & Peking Union Medical College', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100053', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Lei Zhao, M.D.', 'role': 'CONTACT', 'email': 'zhaoalei@sina.com', 'phone': '86 10 83199352'}, {'name': 'Lei Zhao, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Xuanwu Hospital,Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100160', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shu Li, M.D.', 'role': 'CONTACT', 'email': 'lishu@bjtth.org', 'phone': '86 10 59976658'}, {'name': 'Shu Li, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Beijing Tiantan Hospital, Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '430014', 'city': 'Wuhan', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jingli Chen, M.D.', 'role': 'CONTACT', 'email': 'chenjinli2001@sina.com', 'phone': '8610 82811446'}, {'name': 'Jingli Chen, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The Central Hospital of Wuhan, Tongji Medical College, Huazhong University of Science and Technology', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}], 'centralContacts': [{'name': 'Jia Shi, M.D.', 'role': 'CONTACT', 'email': 'shijia@fuwai.com', 'phone': '+86 10 88322467'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data (IPD) will not be shared in order to protect participant privacy and confidentiality. Additionally, the consent obtained from participants does not include provisions for data sharing, in accordance with ethical guidelines and institutional policies.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese Academy of Medical Sciences, Fuwai Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Vice Chair, Department of Anesthesiology', 'investigatorFullName': 'SHI Jia', 'investigatorAffiliation': 'Chinese Academy of Medical Sciences, Fuwai Hospital'}}}}