[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100623616":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":13,"centralContacts":17,"locations":22,"responsibleParty":39,"collaborators":41,"id":45,"slug":7,"hasResults":46,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":46,"sex":52,"minAge":53,"maxAge":7,"enrollmentInfo":54,"targetDuration":7,"studyType":57,"phases":7,"briefSummary":58,"conditions":59,"keywords":62,"overallStatus":73,"whyStopped":7,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"Yale University","OTHER",null,[9],{"type":10,"name":11,"description":12,"armGroupLabels":7,"otherNames":7},"DIAGNOSTIC_TEST","ATTR-CM AI-ECG and AI-Echo Model","AI-based sequential screening approach for ATTR-CM",[14],{"name":15,"affiliation":5,"role":16},"Rohan Khera, MD, MS","PRINCIPAL_INVESTIGATOR",[18],{"name":15,"role":19,"phone":20,"phoneExt":7,"email":21},"CONTACT","203-764-5885","rohan.khera@yale.edu",[23],{"facility":24,"status":7,"city":25,"state":26,"zip":27,"country":28,"cosmosGeoPoint":29,"geoPoint":34,"contacts":35},"Yale New Haven Health System","New Haven","Connecticut","06519","United States",{"type":30,"coordinates":31},"Point",[32,33],-72.92816,41.30815,{"lat":33,"lon":32},[36,38],{"name":15,"role":19,"phone":37,"phoneExt":7,"email":21},"203-764-5585",{"name":15,"role":16,"phone":7,"phoneExt":7,"email":7},{"type":40,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR",[42],{"name":43,"class":44},"Bridgebio Pharma, Inc","UNKNOWN","100623616",false,"NCT07398950","Prospective Evaluation of Artificial Intelligence-enabled Screening for Transthyretin Amyloid Cardiomyopathy (ATTR-CM)","Prospective Evaluation of Artificial Intelligence-enabled Screening for Transthyretin Amyloid Cardiomyopathy (ATTR-CM): TRACE-AI Prospective Study","TRACE-AI Yale","Inclusion Criteria:\n\n* Patients 18 years or older with at least one of each component cardiovascular diagnosis testing (ECG and Echo) in the YNHHS.\n* Patients with a diagnosis of HFpEF or HFmrEF\n* Participant from Phase I TRACE-AI Study with AI-ECG and AI-Echo screen in the preceding 36 months\n\nExclusion Criteria:\n\n* Patients who have opted out of research studies\n* Patients with cardiac amyloid diagnostic test in the past 36 months\n* Patients with hypertrophic cardiomyopathy or end-stage renal disease\n* Pregnant women\n* Patients unable or unwilling to provide informed consent\n* Non-English speakers and cognitively impaired individuals who are unable to comprehend the consent and the on-screen instructions on the application, which are in English.","ALL","18 Years",{"count":55,"type":56},150,"ESTIMATED","OBSERVATIONAL","The TRACE-AI Diagnostic Study will evaluate the performance of artificial intelligence (AI) models applied to electrocardiograms (AI-ECG) and echocardiograms (AI-Echo) to identify transthyretin amyloid cardiomyopathy (ATTR-CM) in adults with heart failure. Model performance will be validated through comparison with technetium-99m pyrophosphate (PYP) imaging results.",[60,61],"ATTR Amyloidosis With Cardiomyopathy","Heart Failure",[63,64,65,66,67,68,69,70,71,72],"Transthyretin Amyloid Cardiomyopathy (ATTR-CM)","Artificial Intelligence Screening","AI-ECG","AI-Echo","Electrocardiogram","Technetium-99m Pyrophosphate (Tc99m-PYP) Scintigraphy","Machine Learning in Cardiology","Validation of AI Diagnostic Tools","Cardiomyopathy Screening","Early Detection of Cardiac Amyloidosis","NOT_YET_RECRUITING","2026-02-04",{"date":76,"type":77},"2026-02-10","ACTUAL",{"date":79,"type":56},"2026-03",{"date":81,"type":56},"2026-12",{"name":5,"class":6},1]