Recruiting

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

Sponsor:

Lancaster General Hospital

Code:

NCT06688396

Conditions

Dilated Cardiomyopathy

Heart Failure

Heart Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Mobile 6L AI-EKG Screening

Study Details

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.

Conditions

Dilated Cardiomyopathy

Heart Failure

Heart Disease

Study ID

NCT06688396

Start date

Dec 4, 2024

Status verified date

Jan, 2025

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

150 participants

Anticipated

Intervention Model

Single group

Primary purpose

Screening

Interventions and Outcome Measures

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.

Interventions

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.

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 and Locations

Central contacts

Halle Becker, MPH

717-544-1777 Halle.Becker@pennmedicine.upenn.edu

Jonathan Derr, MBA

717-544-1777 Jonathan.Derr@pennmedicine.upenn.edu

Locations

Lancaster General Hospital

Recruiting

Lancaster, Pennsylvania, United States, 17602

Contacts

Halle Becker, MPH

717-544-1777 Halle.Becker@pennmedicine.upenn.edu

Jonathan Derr, MBA

717-544-1777 jonathan.derr@pennmedicine.upenn.edu

Principal Investigator:

Roy Small, MD

More Information

Sponsor

Lancaster General Hospital

Last update posted

Jan 30, 2025

Last verified

Jan, 2025

Keywords

Dilated Cardiomyopathy
Heart Failure
Heart Disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Lancaster General Hospital on 2025-01-30.