An interventional study of Mobile 6L AI-EKG Screening in Dilated Cardiomyopathy, Heart Failure and Heart Disease, sponsored by Lancaster General Hospital. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-30.
Sponsored by Lancaster General Hospital · Not applicable, Interventional, and Screening
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.
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.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's planned enrollment of 150 is above the median of 72 across 3,736 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →Lancaster General Hospital is the lead sponsor of 19 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria (Proband)
Inclusion Criteria (FDR)
Exclusion Criteria (Proband)
Ischemic cause of reduced LVEF
Exclusion Criteria (FDR)
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.
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.
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.
The number of consented FDR who successfully undergo AI-EKG and subsequent recommended cardiac follow up.
Time frame: Assessed for a minimum of 3 months post enrollment up to 6 months post enrollment.
Positive AI-EKG screens among FDR of DCM probands (LVEF ≤ 45%)/total population of the FDR of DCM probands undergoing AI-EKG.
Time frame: Assessed at time of EKG results. About 2 weeks post collection.
Responses to decliner survey questions addressing barriers to adoption of AI technology, variables that contribute to the reluctance to participate, and logistical barriers to research. surveys.
Time frame: Assessed at time of decline and survey completion, about 30 minutes.
Positive cardiac screening procedures /total number of FDR undergoing cardiac screening procedures
Time frame: Assessed at 3 months post enrollment check-in or 6 months post enrollment check-in if not completed by 3 months.
Comparison of AI EKG reduced LVEF algorithm results between 6L Kardia EKG and 12L AI EKG, if available, in DCM probands.
Time frame: Assessed during data analysis, 2 years after study start.
Plan to share: No
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Lancaster General Hospital