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RECRUITING

NCT06688396

Dilated Cardiomyopathy Detection Using AI and Screening With Mobile Technology (DCM-DETECT)

Sponsor: Lancaster General Hospital

View on ClinicalTrials.gov

Summary

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.

Official title: Dilated Cardiomyopathy Detection Using Artificial Intelligence and Screening With Mobile Technology

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2024-12-04

Completion Date

2026-12

Last Updated

2025-01-30

Healthy Volunteers

Yes

Conditions

Dilated Cardiomyopathy Heart Failure Heart Disease

Interventions

DEVICE

Mobile 6L AI-EKG Screening

Participants (probands) with DCM will invite their first-degree relatives to undergo DCM screening procedures. Probands 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. If available, the probands clinical 12L EKGs will be obtained if recorded within 30 days of their Kardia 6L recording. All participating FDR will be encouraged to pursue cardiac screening per ACC/AHA recommendations. Study staff will obtain echocardiogram results up to 6 months of participant enrollment.

Inclusion Criteria (Proband) * Male or female age ≥ 18 years * 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 * Must have at least one living adult FDR * Able to provide informed consent Inclusion Criteria (FDR) * Male or female age ≥ 18 years who are first-degree relatives of patients with DCM * Proband has provided informed consent * FDR able to provide informed verbal consent * Access to a smartphone or digital tablet with cellular data or Wi-Fi access Exclusion Criteria (Proband) * DCM attributed to any other secondary form of cardiomyopathy per the investigator's determination * Proband has previously informed FDR to undergo cardiac screening * Ischemic cause of reduced LVEF * evidence of myocardial infarction, inducible ischemia or chest pain on stress testing in absence of coronary angiogram to rule out ischemic disease * 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 * Moderate or greater primary valvular abnormality not due to underlying cardiomyopathy * Congenital structural heart disease * Severe and untreated or untreatable hypertension * Cardiomyopathy due to acute or reversible conditions; examples include tachyarrhythmias, thyroid disorders, iron overload * Any secondary cause of reduced LVEF such as pregnancy, myocarditis, amyloidosis, sarcoidosis, exposure to toxins including alcohol, substance abuse or chemotherapeutic drug * (CPC Participants only) Home address outside of traveling range Exclusion Criteria (FDR) * Previously informed about cardiac screening or has completed cardiac screening by transthoracic echocardiogram (TTE) * Previously diagnosed with reduced LVEF * (CPC Participants only) Home address outside of traveling range

Locations (1)

Lancaster General Hospital

Lancaster, Pennsylvania, United States