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

Not Applicable

Recruiting

• Conditions: Dilated Cardiomyopathy; Heart Failure; Heart Disease

• Registration Number: NCT06688396
• Lead Sponsor: Lancaster General Hospital

Brief 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.

Detailed Description

The purpose of this study is to examine the impact of an "Artificial Intelligent" (AI) enhanced 6Lead (6L) mobile electrocardiogram (EKG) in encouraging first degree relatives (FDR) of probands with a dilated cardiomyopathy (DCM) to obtain appropriate cardiac screening.

The AI enhanced EKG (AI-EKG) will be acquired using the AliveCor KardiaMobile 6L system which allows the generation of prediction probabilities for reduced left ventricular function (LVEF). The AliveCor KardiaMobile 6L device is an FDA approved handheld smart device that records an EKG in 30 seconds to 5-minute increments. The device is an ambulatory wireless device that connects to a smartphone and is easy to use. The EKG signal is communicated wirelessly via Bluetooth to a mobile computing platform (MCP) which can be a smartphone or tablet. The MCP will be running either the KardiaRx mobile application if the participant is remote, or the KardiaStation App if the participation is on sight at either the Lancaster General Hospital (LGH) campus or the Central Pennsylvania Clinic (CPC) location. The 6L EKG is transmitted following processing by the Kardia Apps. The results of the EKG tracings recorded by the AliveCor devices will not be entered into the electronic medical record or used to guide clinical care. The EKG data from the recordings identified only by the connection code will be uploaded to the AliveCor cloud for proprietary AI analysis designed to detect impaired LVEF. This AI software for LVEF analysis is FDA approved.

All participating FDR will be encouraged to pursue cardiac screening per American College of Cardiology/American Heart Association (ACC/AHA) recommendations.

If available, the probands clinical 12Lead (12L) EKGs will be obtained if recorded within 30 days of their Kardia 6L recording. The concordance of the algorithm results applied to the Kardia 6L data with the 12L FDA approved LVEF algorithm results will be assessed.

Study Timeline

• Study First Submitted: 2024-11-12
• Study First Submitted QC: 2024-11-12
• Study First Posted: 2024-11-14
• Study Start: 2024-12-04
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-28
• Last Update Posted: 2025-01-30
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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.	Assessed for a minimum of 3 months post enrollment up to 6 months post enrollment.	The number of consented FDR who successfully undergo AI-EKG and subsequent recommended cardiac follow up.

Secondary Outcome Measures

Name	Time	Method
Positive AI-EKG screens among FDR of DCM probands (LVEF ≤ 45%)/total population of the FDR of DCM probands undergoing AI-EKG.	Assessed at time of EKG results. About 2 weeks post collection.

Trial Locations

Locations (1)

Lancaster General Hospital; 🇺🇸 Lancaster, Pennsylvania, United States