DCM-DETECT: AI-EKG Screening for Dilated Cardiomyopathy

This study, called DCM-DETECT, is looking at how well a mobile device with artificial intelligence (AI) can help find Dilated Cardiomyopathy (DCM) in family members. DCM is a heart condition where the heart muscle becomes stretched and thin, making it harder to pump blood. The study uses a mobile 6L AI-EKG (electrocardiogram) device called AliveCor KardiaMobile 6L. If you have DCM, you would invite your adult first-degree relatives (like parents, siblings, or children) to use this device for heart screening. The main goal is to see if this AI-EKG test is practical to use and if it encourages relatives of people with DCM to get screened for the condition. The study is currently unclear on its status and plans to enroll 150 participants aged 18 and older.

Study design
This is a single-arm study, meaning all participants receive the same intervention. It aims to enroll 150 participants.
What's involved
Participants with DCM will invite their first-degree relatives to complete a mobile 6L AI-EKG. The results will be sent to a mobile app and interpreted by an AI algorithm.
Compensation
Not stated in the trial record.
Follow-up
Participants will be assessed for a minimum of 3 months up to 6 months after enrollment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06688396

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

Recruiting
NAAges 18+InterventionalScreening
Lancaster General Hospital
~150 participants
Updated 2025-01-30 on ClinicalTrials.gov
What's tested:Mobile 6L AI-EKG Screening

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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.
Measured over Assessed for a minimum of 3 months post enrollment up to 6 months post enrollment.
Dilated Cardiomyopathy
Heart Failure
Heart Disease
1 sites across 1 states
Pennsylvania1
  • Roy Small, MD · PRINCIPAL_INVESTIGATOR · Penn Medicine / Lancaster General Hospital

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Eligibility criteria

Inclusion

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
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

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
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
  • 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.