[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100652459":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":35,"responsibleParty":49,"collaborators":18,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":18,"eligibilityCriteria":57,"healthyVolunteers":53,"sex":58,"minAge":59,"maxAge":18,"enrollmentInfo":60,"targetDuration":18,"studyType":63,"phases":64,"briefSummary":66,"conditions":67,"keywords":71,"overallStatus":77,"whyStopped":18,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"Seoul National University Bundang Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"AI-ECG-guided preoperative strategy","EXPERIMENTAL","Patients undergo preoperative cardiovascular risk stratification guided by the output of the AI-ECG device (ECG Buddy). Further preoperative cardiovascular evaluation and cardiology consultation are directed according to the AI-ECG-based assessment.",[13],"Diagnostic Test: AI-ECG-based preoperative risk stratification (ECG Buddy)",{"label":15,"type":16,"description":17,"interventionNames":18},"Usual care","NO_INTERVENTION","Patients receive usual preoperative care for cardiovascular evaluation according to standard institutional practice, without use of the AI-ECG-based strategy.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DIAGNOSTIC_TEST","AI-ECG-based preoperative risk stratification (ECG Buddy)","A standard 12-lead ECG is analyzed by an AI-enhanced ECG algorithm (ECG Buddy) to stratify preoperative cardiovascular risk. Designated AI-ECG biomarkers are used as decision thresholds to guide subsequent preoperative cardiovascular evaluation and cardiology consultation.",[9],[26],{"name":27,"affiliation":28,"role":29},"Ji Hyun Lee, MD","Seul National University Bundang Hospital","PRINCIPAL_INVESTIGATOR",[31],{"name":27,"role":32,"phone":33,"phoneExt":18,"email":34},"CONTACT","82-31-787-7045","jihyunlee310@snubh.org",[36],{"facility":5,"status":18,"city":37,"state":38,"zip":39,"country":40,"countryCode":18,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Seongnam-si","Gyeonggido","13620","South Korea",{"type":42,"coordinates":43},"Point",[44,45],127.13778,37.43861,{"lat":45,"lon":44},[48],{"name":27,"role":32,"phone":33,"phoneExt":18,"email":34},{"type":50,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100652459","ai-ecg-for-preoperative-cardiovascular-risk-stratification-before-general-surgery-100652459",false,"NCT07774689","AI-ECG for Preoperative Cardiovascular Risk Stratification Before General Surgery","Utilization of AI-ECG for Preoperative Cardiovascular Risk Stratification in General Surgery: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Adults aged 20 years or older\n* Patients scheduled for elective (non-emergent) general surgery\n* Willing and able to provide voluntary written informed consent\n\nExclusion Criteria:\n\n* Emergency surgery\n* Surgery under local anesthesia","ALL","20 Years",{"count":61,"type":62},3200,"ESTIMATED","INTERVENTIONAL",[65],"NA","This randomized controlled trial evaluates whether an artificial intelligence-enhanced electrocardiography (AI-ECG)-based strategy for preoperative cardiovascular risk stratification is noninferior to usual care in patients undergoing elective general surgery. Eligible patients are randomly assigned to either an AI-ECG-guided preoperative assessment strategy or usual preoperative care.\n\nThe primary outcome is the incidence of major adverse cardiovascular events (MACE) within 30 days after surgery, defined as a composite of all-cause death, ventricular fibrillation\u002Ftachycardia or cardiac arrest, non-fatal myocardial infarction, unplanned revascularization (PCI or CABG), mechanical ventilation for ≥3 days, and acute heart failure requiring intravenous diuretics.\n\nSecondary outcomes include the rate of preoperative cardiac imaging and functional testing (echocardiography, coronary CT, SPECT, stress test), the rate of preoperative cardiology consultation, length of hospital stay, direct medical costs, and the time required for preoperative evaluation. The study aims to determine whether AI-ECG can safely guide preoperative cardiovascular evaluation while reducing unnecessary testing, resource use, and cost.",[68,69,70],"Perioperative Cardiovascular Risk","Postoperative Complications (Cardiopulmonary)","Preoperative Care",[72,73,74,75,76],"Artificial intelligence","Electrocardiography","Perioperative cardiovascular risk","Preoperative evaluation","Major adverse cardiovascular events","NOT_YET_RECRUITING","2026-08-17",{"date":80,"type":81},"2026-08-19","ACTUAL",{"date":83,"type":62},"2026-09-01",{"date":85,"type":62},"2029-05-31",{"name":5,"class":6},1]