[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100594603":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":24,"locations":25,"responsibleParty":38,"collaborators":24,"id":42,"slug":43,"hasResults":44,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":44,"sex":50,"minAge":51,"maxAge":24,"enrollmentInfo":52,"targetDuration":24,"studyType":55,"phases":56,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":66,"whyStopped":24,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":76},{"fullName":5,"class":6},"Prince of Wales Hospital, Shatin, Hong Kong","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Tailored AI echocardiogram analysis and reporting system","EXPERIMENTAL","An experienced cardiologist will be provided with AI's measurements, draft disease grading and report for review. The experienced cardiologist will provide a final grading of left ventricular function, AS and MR on the standardized grading chart, and endorse the final echocardiogram report.",[13],"Diagnostic Test: Tailored AI echocardiogram analysis and reporting system",{"label":15,"type":16,"description":17,"interventionNames":18},"Echocardiologist interpretation and analysis of Echo images","ACTIVE_COMPARATOR","An experienced cardiologist (with American Society of Echocardiography level III capacity), will be provided with sonographer's measurements, draft disease grading and report for review.",[13],[20],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"DIAGNOSTIC_TEST","In the AI analysis and reporting pathway, sonographers only need to acquire the echocardiogram images, then the AI algorithm will complete the analysis and report drafting for final endorsement by experienced cardiologists. To ensure blinding of group assignment to the endorsing experienced cardiologists, measurement format and reporting phrases and interface used by AI and sonographers will be standardized.",[15,9],null,[26],{"facility":27,"status":24,"city":28,"state":29,"zip":30,"country":28,"countryCode":31,"cosmosGeoPoint":32,"geoPoint":37,"contacts":24},"Prince of Wales Hospital","Hong Kong","Shatin","0000","HK",{"type":33,"coordinates":34},"Point",[35,36],114.17469,22.27832,{"lat":36,"lon":35},{"type":39,"investigatorFullName":40,"investigatorTitle":41,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"PRINCIPAL_INVESTIGATOR","Dr So Chak Yu kent","Clinincal Assistant Professor","100594603","artificial-intelligence-versus-sonographer-echocardiogram-analysis-and-reporting-in-patients-with-heart-failure-100594603",false,"NCT07021599","Artificial Intelligence Versus Sonographer Echocardiogram Analysis and Reporting in Patients With Heart Failure","Artificial Intelligence Versus Sonographer Echocardiogram Analysis and Reporting in Patients With Heart Failure: A Randomized Controlled Trial","AISEARHF","Inclusion Criteria:\n\n* Aged 18 years or above\n* Has new or worsening of heart failure symptoms\n* Elevated heart failure blood markers (N-terminal prohormone of brain natriuretic peptide, \"NTproBNP\") within 3 months from enrolment or by point-of-care blood test, to ensure that the patient's symptoms are cardiac origin\n* Provision of written informed consent\n\nExclusion Criteria:\n\n* Known severe valvular heart disease\n* Prior prosthetic valve implantation\n* Previously known or suspected \\>=severe tricuspid regurgitation, \\>=moderate aortic regurgitation, \\>=moderate mitral stenosis or pericardial disease during detected during image acquisition\n* Insufficient image quality for proper analysis determined by the scanning sonographer (estimated to be 15% of all echocardiograms screened)","ALL","18 Years",{"count":53,"type":54},514,"ESTIMATED","INTERVENTIONAL",[57],"NA","This is a non-inferiority, three-year, multicenter, double-blinded randomized controlled study of an AI versus experienced sonographer echocardiogram analysis in HF patients. Consecutive patients presented for echocardiogram examination with new or worsening HF symptom and positive HF blood markers will be recruited. A target of 514 patients will be randomized 1:1 to receive either AI or sonographer echocardiogram analysis. The primary endpoint of diagnostic accuracy is the complete agreement of disease grading with an experienced cardiologist (American Society of Echocardiography level III) using a standardized grading chart. Important secondary endpoints include the time used for echocardiogram report drafting and report endorsement, 6-month heart failure symptom and hospitalization, and the cost-effectiveness of AI to increase echocardiogram service. Clinical, biochemical and echocardiographic predictors of worsening of heart failure and hospitalization will be identified.",[60],"Heart Failure",[62,63,64,65],"Echocardiogram","Artificial Intelligence","Alogrithm","Echocardiological image analysis","NOT_YET_RECRUITING","2025-06-13",{"date":69,"type":70},"2025-06-15","ACTUAL",{"date":72,"type":54},"2025-07-01",{"date":74,"type":54},"2028-12-03",{"name":5,"class":6},1]