[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06749145":3,"trial-entities:NCT06749145":107,"trial-summary:NCT06749145":111},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":49,"secondary_outcomes":54,"sex":55,"minimum_age":56,"maximum_age":16,"healthy_volunteers":14,"eligibility_criteria":57,"std_ages":73,"locations":75,"central_contacts":100,"overall_officials":101,"references":105,"see_also_links":106},"NCT06749145","2000038634","Deep Learning Enhanced Detection of Aortic Stenosis - The DETECT-AS-Diagnostic Study","ENROLLING_BY_INVITATION","2028-08-31","2025-11","2025-11-26","2025-09-16","Yale University","OTHER",true,"The DETECT-AS Diagnostic Study will assess the performance of artificial intelligence (AI) risk predictions to detect aortic stenosis using results from portable electrocardiogram (ECG) and cardiac ultrasound devices.",null,[18],"Aortic Stenosis",[20,21],"aortic stenosis","artificial intelligence","INTERVENTIONAL","DIAGNOSTIC",[25],"NA",{"count":27,"type":28},410,"ESTIMATED",[30,37,41,45],{"type":31,"name":32,"description":33,"armGroupLabels":34},"DIAGNOSTIC_TEST","Portable 1-lead electrocardiogram","Portable 1-lead electrocardiogram (ECG) performed with the FDA-approved AliveCor KardiaMobile device.",[35,36],"Control","Intervention",{"type":31,"name":38,"description":39,"armGroupLabels":40},"Point-of-care ultrasound","Point-of-care ultrasound performed with the FDA-approved VScan Air device.",[35,36],{"type":13,"name":42,"description":43,"armGroupLabels":44},"AI-ECG risk algorithm","Artificial intelligence (AI) risk algorithm for aortic stenosis using a 1-lead electrocardiogram",[36],{"type":13,"name":46,"description":47,"armGroupLabels":48},"AI-POCUS","Artificial intelligence (AI) risk algorithm for aortic stenosis using cardiac ultrasound plax videos.",[36],[50],{"measure":51,"description":52,"timeFrame":53},"Number of participants diagnosed with advanced aortic stenosis (AS) by transthoracic echocardiogram (TTE)","The number of participants diagnosed with advanced AS by TTE at 12 months. Diagnosis of advanced AS is defined as diagnosis of moderate or severe AS as documented in the participant's electronic health record (EHR) at 12 months and adjudication of outcome via review of echocardiographic reports and videos performed by blinded members of the echocardiographic lab at the coordinating center.","Until 12 months from the baseline visit",[],"ALL","70 Years",{"inclusion":58,"exclusion":61,"raw_text":72},[59,60],"Age 70 years or older","Attending a routine outpatient primary care clinic at one of the three enrollment sites",[62,63,64,65,66,67,68,69,70,71],"Opted out of research studies","Non-English speaking","Urgent or emergent visits, defined as a visit for an illness or injury that needs attention quickly or is life-threatening","Any echocardiogram within 12 months of clinic visit","Prior history of moderate or severe AS","Prior history of aortic valve replacement or repair, including transcatheter and surgical AVR with either a bioprosthetic or mechanical valve","Presence of implantable cardiac devices, including permanent cardiac pacer, implantable cardioverter-defibrillator, or left ventricular assist device","Prior heart transplant","History of dementia","Documented life expectancy of \\\u003C1 year or current participation in hospice services.","Inclusion Criteria:\n\n* Age 70 years or older\n* Attending a routine outpatient primary care clinic at one of the three enrollment sites\n\nExclusion Criteria:\n\n* Opted out of research studies\n* Non-English speaking\n* Urgent or emergent visits, defined as a visit for an illness or injury that needs attention quickly or is life-threatening\n* Any echocardiogram within 12 months of clinic visit\n* Prior history of moderate or severe AS\n* Prior history of aortic valve replacement or repair, including transcatheter and surgical AVR with either a bioprosthetic or mechanical valve\n* Presence of implantable cardiac devices, including permanent cardiac pacer, implantable cardioverter-defibrillator, or left ventricular assist device\n* Prior heart transplant\n* History of dementia\n* Documented life expectancy of \\\u003C1 year or current participation in hospice services.",[74],"OLDER_ADULT",[76,85,92],{"facility":77,"city":78,"state":79,"zip":80,"country":81,"geoPoint":82},"Yale New Haven Health System","New Haven","Connecticut","06519","United States",{"lat":83,"lon":84},41.30815,-72.92816,{"facility":86,"city":87,"state":87,"zip":88,"country":81,"geoPoint":89},"Icahn School of Medicine at Mount Sinai","New York","10029",{"lat":90,"lon":91},40.71427,-74.00597,{"facility":93,"city":94,"state":95,"zip":96,"country":81,"geoPoint":97},"The Methodist Hospital Research Institute","Houston","Texas","77030",{"lat":98,"lon":99},29.76328,-95.36327,[],[102],{"name":103,"affiliation":12,"role":104},"Rohan Khera, MD, MS","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":108,"biomarkers":110},[109],"Aortic Valve Stenosis",[],{"nct_id":4,"found":112,"summary":16,"prompt_version":16},false]