[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100596633":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":30,"locations":36,"responsibleParty":108,"collaborators":25,"id":111,"slug":112,"hasResults":113,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":117,"eligibilityCriteria":118,"healthyVolunteers":113,"sex":119,"minAge":120,"maxAge":25,"enrollmentInfo":121,"targetDuration":25,"studyType":124,"phases":125,"briefSummary":127,"conditions":128,"keywords":25,"overallStatus":39,"whyStopped":25,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":142},{"fullName":5,"class":6},"Chinese Academy of Medical Sciences, Fuwai Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"NeuroFirst target bundle","EXPERIMENTAL","Management for NeuroFirst target bundle",[13],"Other: Managements for NeuroFirst target bundle",{"label":15,"type":16,"description":17,"interventionNames":18},"Routine Management","ACTIVE_COMPARATOR","Management for institutional routine in accordance with published guidelines",[19],"Other: Managements for institutional routine",[21,26],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"Managements for NeuroFirst target bundle","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 \\\u003C37 ℃ and rewarming rate \\\u003C 0.5 ℃\u002Fmin 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.",[9],null,{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Managements for institutional routine","MAP, BIS, cerebral rSO2 and arterial inflow temperature during CPB rewarming, will be managed according to institutional routine in accordance with published guidelines.",[15],[31],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},"Jia Shi, M.D.","CONTACT","+86 10 88322467","shijia@fuwai.com",[37,58,68,80,92],{"facility":38,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Beijing Chaoyang Hospital，Capital Medical University","RECRUITING","Beijing","Beijing Municipality","100020","China","CN",{"type":46,"coordinates":47},"Point",[48,49],116.39723,39.9075,{"lat":49,"lon":48},[52,56],{"name":53,"role":33,"phone":54,"phoneExt":25,"email":55},"Changwei Wei, M.D.","8610 85231330","wcw0025@sina.com",{"name":53,"role":57,"phone":25,"phoneExt":25,"email":25},"PRINCIPAL_INVESTIGATOR",{"facility":59,"status":39,"city":40,"state":41,"zip":60,"country":43,"countryCode":44,"cosmosGeoPoint":61,"geoPoint":63,"contacts":64},"State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences & Peking Union Medical College","100037",{"type":46,"coordinates":62},[48,49],{"lat":49,"lon":48},[65,67],{"name":32,"role":33,"phone":66,"phoneExt":25,"email":35},"86 10 88322467",{"name":32,"role":57,"phone":25,"phoneExt":25,"email":25},{"facility":69,"status":39,"city":40,"state":41,"zip":70,"country":43,"countryCode":44,"cosmosGeoPoint":71,"geoPoint":73,"contacts":74},"Xuanwu Hospital,Capital Medical University","100053",{"type":46,"coordinates":72},[48,49],{"lat":49,"lon":48},[75,79],{"name":76,"role":33,"phone":77,"phoneExt":25,"email":78},"Lei Zhao, M.D.","86 10 83199352","zhaoalei@sina.com",{"name":76,"role":57,"phone":25,"phoneExt":25,"email":25},{"facility":81,"status":39,"city":40,"state":41,"zip":82,"country":43,"countryCode":44,"cosmosGeoPoint":83,"geoPoint":85,"contacts":86},"Beijing Tiantan Hospital, Capital Medical University","100160",{"type":46,"coordinates":84},[48,49],{"lat":49,"lon":48},[87,91],{"name":88,"role":33,"phone":89,"phoneExt":25,"email":90},"Shu Li, M.D.","86 10 59976658","lishu@bjtth.org",{"name":88,"role":57,"phone":25,"phoneExt":25,"email":25},{"facility":93,"status":39,"city":94,"state":95,"zip":96,"country":43,"countryCode":44,"cosmosGeoPoint":97,"geoPoint":101,"contacts":102},"The Central Hospital of Wuhan, Tongji Medical College, Huazhong University of Science and Technology","Wuhan","Hubei","430014",{"type":46,"coordinates":98},[99,100],114.26667,30.58333,{"lat":100,"lon":99},[103,107],{"name":104,"role":33,"phone":105,"phoneExt":25,"email":106},"Jingli Chen, M.D.","8610 82811446","chenjinli2001@sina.com",{"name":104,"role":57,"phone":25,"phoneExt":25,"email":25},{"type":57,"investigatorFullName":109,"investigatorTitle":110,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"SHI Jia","Vice Chair, Department of Anesthesiology","100596633","interventions-for-silent-brain-infarction-and-perioperative-neurocognitive-disorders-in-cardiovascular-surgery-100596633",false,"NCT07048002","Interventions for Silent Brain Infarction and Perioperative Neurocognitive Disorders in Cardiovascular Surgery","Interventions for Silent Brain Infarction and Perioperative Neurocognitive Disorders in Cardiovascular Surgery (the INSPIRE Study)","INSPIRE","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","ALL","60 Years",{"count":122,"type":123},912,"ESTIMATED","INTERVENTIONAL",[126],"NA","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.",[129,130,131,132],"Silent Brain Infarction","Neurocognitive Disorders","Cardiac Surgery","Neuroprotective","2025-11-19",{"date":135,"type":136},"2025-11-24","ACTUAL",{"date":138,"type":136},"2025-07-06",{"date":140,"type":123},"2028-10-31",{"name":5,"class":6},5]