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

Part of paid clinical trials in Lancaster, Pennsylvania.

Sponsor
Lancaster General Hospital
Study ID
NCT06688396
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Mobile 6L AI-EKG Screening — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Dec 4, 2024
Status verified
Jan 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
150 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING

Arms

  • Experimental: DCM Screening
    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.

Primary Outcome Measure

This study's primary endpoint is to assess the feasibility of performing AI-EKG test and the subsequent uptake of cardiac screening in FDR of DCM patients. [ Time Frame: Assessed for a minimum of 3 months post enrollment up to 6 months post enrollment. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Lancaster General HospitalLancasterPennsylvania17602
Halle Becker, MPH
[email protected]
717-544-1777
Jonathan Derr, MBA
[email protected]
717-544-1777
Roy Small, MD (PRINCIPAL_INVESTIGATOR)

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