[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100650944":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":25,"locations":35,"responsibleParty":64,"collaborators":18,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":69,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":18,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":89,"overallStatus":103,"whyStopped":18,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"University of Texas Southwestern Medical Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"AI-POCUS Screening","EXPERIMENTAL","Trained clinic staff perform AI-guided point-of-care ultrasound using the Kosmos Torso-One device on eligible patients during routine primary care or geriatrics visits. Patients with ≥ moderate valvular heart disease or EF ≤50% are referred for confirmatory echocardiography within 90 days.",[13],"Device: Kosmos Torso-One AI-guided Point-of-Care Ultrasound (EchoNous, Inc.)",{"label":15,"type":16,"description":17,"interventionNames":18},"Usual Care","NO_INTERVENTION","Eligible patients receive standard provider-driven care. Echocardiography referral occurs per routine clinical indications such as auscultated murmur or patient-reported symptoms.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DEVICE","Kosmos Torso-One AI-guided Point-of-Care Ultrasound (EchoNous, Inc.)","A single AI-guided handheld POCUS examination performed by trained clinic staff (medical or certified nursing assistants) during a routine primary care or geriatrics visit. Acquisition is standardized, including parasternal long- and short-axis and apical 3- and 4-chamber views, with 2D imaging, color Doppler, M-mode of the mitral valve, and continuous-wave Doppler of the aortic and mitral valves. Images are transmitted to a central echocardiographic core laboratory, which screens for adequacy; adequate studies are analyzed by pre-specified AI algorithms based on 2017 ASE guidelines, blinded to arm assignment. A positive screen is defined as moderate or greater valvular heart disease or left ventricular ejection fraction of 50% or less. Positive results are communicated to the participant's primary care provider with a recommendation to consider confirmatory TTE; ordering remains at provider discretion, and the study team facilitates completion within 90 days of index visit.",[9],[26,31],{"name":27,"role":28,"phone":29,"phoneExt":18,"email":30},"Dharam J Kumbhani, MD, SM, MRCP, FACC, FAHA, FSCA","CONTACT","214-645-7508","dharam.kumbhani@utsouthwestern.edu",{"name":32,"role":28,"phone":18,"phoneExt":33,"email":34},"Ritika Dhruve, MBBS, MPH","214-810-4503","ritika.dhruve@utsouthwestern.edu",[36,56],{"facility":37,"status":18,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Parkland Health","Dallas","Texas","75390","United States","US",{"type":44,"coordinates":45},"Point",[46,47],-96.80667,32.78306,{"lat":47,"lon":46},[50,51,53],{"name":27,"role":28,"phone":29,"phoneExt":18,"email":30},{"name":52,"role":28,"phone":18,"phoneExt":33,"email":34},"Ritika J Dhruve, MBBS, MPH",{"name":54,"role":55,"phone":18,"phoneExt":18,"email":18},"Dharam J Kumbhani, MD","PRINCIPAL_INVESTIGATOR",{"facility":5,"status":18,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":57,"geoPoint":59,"contacts":60},{"type":44,"coordinates":58},[46,47],{"lat":47,"lon":46},[61,62,63],{"name":27,"role":28,"phone":29,"phoneExt":18,"email":30},{"name":52,"role":28,"phone":18,"phoneExt":33,"email":34},{"name":54,"role":55,"phone":18,"phoneExt":18,"email":18},{"type":55,"investigatorFullName":65,"investigatorTitle":66,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Dharam Kumbhani","Professor of Medicine","100650944","importance-of-point-of-care-ultrasound-for-early-detection-of-valvular-and-cardiac-diseases-improve-100650944",false,"NCT07756398","Importance of Point-of-Care Ultrasound for Early Detection of Valvular and Cardiac Diseases (IMPROVE)","IMPROVE","Inclusion Criteria:\n\nProvider (cluster) participants:\n\n* Physician or advanced practice provider (physician assistant or nurse practitioner) practicing in primary care or geriatrics at a participating institution who independently assesses patients\n* Patient panel comprising \\>50% adults aged 65 years or older\n* Sees patients in ambulatory clinic at least 1 day per week on average\n* Agrees to participate, to undergo randomization, and to permit inclusion of all eligible patients from the panel\n* Provides written informed consent\n\nPatient participants:\n\n* Adults aged 65 to 85 years, inclusive\n* Attending a scheduled outpatient visit at a participating geriatrics or primary care clinic\n* Willing and able to provide written informed consent and, if the AI-POCUS screen is positive, to return for a confirmatory echocardiogram\n\nExclusion Criteria:\n\nProvider (cluster) participants:\n\n* Serving in a locum tenens or other temporary capacity\n* Unwilling or unable to nominate an AI-POCUS champion from the clinic\n\nPatient participants:\n\n* Echocardiogram performed within the past 5 years\n* At least moderate aortic or mitral valve disease, or left ventricular ejection fraction 50% or less, documented on any prior echocardiogram\n* History of surgical or transcatheter intervention for aortic or mitral valve disease\n* Self-reported structural heart disease\n* Significant frailty burden or comorbidities limiting life expectancy to\n\n  1 year or less\n* Unable to provide informed consent","ALL","65 Years","85 Years",{"count":78,"type":79},1088,"ESTIMATED","INTERVENTIONAL",[82],"NA","Heart valve disease and weakened heart muscle (left ventricular systolic dysfunction) are common in older adults and often go undetected until serious complications such as heart failure develop. Detection currently depends on a clinician hearing a murmur and then ordering an echocardiogram, which is easily missed or delayed.\n\nThis study tests whether a brief, artificial intelligence (AI)-guided handheld heart ultrasound - point-of-care ultrasound, or POCUS - performed by trained clinic staff during a routine visit identifies these conditions earlier than usual care.\n\nPrimary care and geriatrics providers, rather than individual patients, are assigned by chance to one of two groups. Patients seen by providers in the AI-ultrasound group are offered a POCUS scan and a one-time blood test at their regular visit, and are referred for a confirmatory echocardiogram if the scan is abnormal. Patients seen by providers in the usual care group receive standard clinic care. Researchers will compare how often previously undiagnosed structural heart disease is newly identified in each group.",[85,86,87,88],"Valvular Heart Disease Patients","Aortic Stenosis","Mitral Regurgitation","Left Ventricular Diastolic Dysfunction",[90,91,92,93,94,95,96,97,98,99,100,101,102],"Point-of-care ultrasound","POCUS","Artificial Intelligence","AI-guided imaging","Echocardiography","Screening","Early detection","Heart Failure","Older Adults","Geriatrics","Primary Care","Cluster randomized Trial","Implementation Science","NOT_YET_RECRUITING","2026-08-12",{"date":106,"type":107},"2026-08-17","ACTUAL",{"date":109,"type":79},"2026-08-01",{"date":111,"type":79},"2028-12-01",{"name":5,"class":6},2]