RecruitingNot ApplicableNCT06688396

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

Dilated Cardiomyopathy Detection Using Artificial Intelligence and Screening With Mobile Technology

Sponsor

Lancaster General Hospital

Enrollment

150 participants

Start Date

Dec 4, 2024

Study Type

INTERVENTIONAL

Conditions

Heart Failure Heart Disease Dilated Cardiomyopathy

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria8

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 Criteria14

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

Interventions

DEVICEMobile 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.