[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100568988":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":35,"responsibleParty":54,"collaborators":56,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":67,"sex":68,"minAge":69,"maxAge":20,"enrollmentInfo":70,"targetDuration":20,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":81,"overallStatus":37,"whyStopped":20,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Lancaster General Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"DCM Screening","EXPERIMENTAL","Participants (probands) with dilated cardiomyopathy (DCM) will invite their first-degree relatives (FDR) to participate in DCM screening to examine the impact of an \"Artificial Intelligent\" (AI) enhanced 6lead (6L) mobile electrocardiogram (EKG) in encouraging FDR of probands with a DCM to obtain appropriate cardiac screening.",[13],"Device: Mobile 6L AI-EKG Screening",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Mobile 6L AI-EKG Screening","Participants (probands) with DCM will invite their first-degree relatives to undergo DCM screening procedures.\n\nProbands and first-degree relatives will complete a mobile 6L AI-EKG which will be transmitted to a mobile app and interpreted by the AI-EKG algorithm. Results will be shared electronically or verbally to the participant.\n\nIf available, the probands clinical 12L EKGs will be obtained if recorded within 30 days of their Kardia 6L recording.\n\nAll participating FDR will be encouraged to pursue cardiac screening per ACC\u002FAHA recommendations. Study staff will obtain echocardiogram results up to 6 months of participant enrollment.",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Roy Small, MD","Penn Medicine \u002F Lancaster General Hospital","PRINCIPAL_INVESTIGATOR",[27,32],{"name":28,"role":29,"phone":30,"phoneExt":20,"email":31},"Halle Becker, MPH","CONTACT","717-544-1777","Halle.Becker@pennmedicine.upenn.edu",{"name":33,"role":29,"phone":30,"phoneExt":20,"email":34},"Jonathan Derr, MBA","Jonathan.Derr@pennmedicine.upenn.edu",[36],{"facility":5,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"RECRUITING","Lancaster","Pennsylvania","17602","United States","US",{"type":44,"coordinates":45},"Point",[46,47],-76.30551,40.03788,{"lat":47,"lon":46},[50,51,53],{"name":28,"role":29,"phone":30,"phoneExt":20,"email":31},{"name":33,"role":29,"phone":30,"phoneExt":20,"email":52},"jonathan.derr@pennmedicine.upenn.edu",{"name":23,"role":25,"phone":20,"phoneExt":20,"email":20},{"type":55,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[57],{"name":58,"class":6},"Mayo Clinic","100568988","dilated-cardiomyopathy-detection-using-ai-and-screening-with-mobile-technology-dcm-detect-100568988",false,"NCT06688396","Dilated Cardiomyopathy Detection Using AI and Screening With Mobile Technology (DCM-DETECT)","Dilated Cardiomyopathy Detection Using Artificial Intelligence and Screening With Mobile Technology","DCM-DETECT","Inclusion Criteria (Proband)\n\n* Male or female age ≥ 18 years\n* Confirmed diagnosis of non-ischemic DCM determined at the discretion of the treating physician and defined as LVEF ≤ 45% at any time during the clinical course of the patient\n* Must have at least one living adult FDR\n* Able to provide informed consent\n\nInclusion Criteria (FDR)\n\n* Male or female age ≥ 18 years who are first-degree relatives of patients with DCM\n* Proband has provided informed consent\n* FDR able to provide informed verbal consent\n* Access to a smartphone or digital tablet with cellular data or Wi-Fi access\n\nExclusion Criteria (Proband)\n\n* DCM attributed to any other secondary form of cardiomyopathy per the investigator's determination\n* Proband has previously informed FDR to undergo cardiac screening\n* Ischemic cause of reduced LVEF\n\n  * evidence of myocardial infarction, inducible ischemia or chest pain on stress testing in absence of coronary angiogram to rule out ischemic disease\n  * history of acute coronary syndromes (STEMI (ST-Elevation Myocardial Infarction), NSTEMI (Non-ST-Elevation Myocardial Infarction) or unstable angina) revascularization or ≥75% stenosis of either left main or Left Anterior Descending (LAD) or ≥75% stenosis of 2 major epicardial vessels on angiogram\n* Moderate or greater primary valvular abnormality not due to underlying cardiomyopathy\n* Congenital structural heart disease\n* Severe and untreated or untreatable hypertension\n* Cardiomyopathy due to acute or reversible conditions; examples include tachyarrhythmias, thyroid disorders, iron overload\n* Any secondary cause of reduced LVEF such as pregnancy, myocarditis, amyloidosis, sarcoidosis, exposure to toxins including alcohol, substance abuse or chemotherapeutic drug\n* (CPC Participants only) Home address outside of traveling range\n\nExclusion Criteria (FDR)\n\n* Previously informed about cardiac screening or has completed cardiac screening by transthoracic echocardiogram (TTE)\n* Previously diagnosed with reduced LVEF\n* (CPC Participants only) Home address outside of traveling range",true,"ALL","18 Years",{"count":71,"type":72},150,"ESTIMATED","INTERVENTIONAL",[75],"NA","This is a prospective, single-arm clinical trial in which participants with dilated cardiomyopathy will invite their first degree relatives to undergo mobile cardiac, electrocardiogram screening.",[78,79,80],"Dilated Cardiomyopathy","Heart Failure","Heart Disease",[78,79,80],"2025-01-28",{"date":84,"type":85},"2025-01-30","ACTUAL",{"date":87,"type":85},"2024-12-04",{"date":89,"type":72},"2026-12",{"name":5,"class":6},1]