Using AI and mobile technology to screen for dilated cardiomyopathy in family members

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the effectiveness of an AI-enhanced mobile electrocardiogram (EKG) in encouraging first-degree relatives of patients with dilated cardiomyopathy (DCM) to undergo cardiac screening. Participants with DCM will invite their relatives to use the AliveCor KardiaMobile 6L device, which records EKGs and analyzes them for signs of reduced left ventricular function. The study will utilize a single-arm design, focusing on the impact of mobile technology on screening rates among family members. The EKG data will be processed using proprietary AI software to identify potential cardiac issues.

Why it matters

Who can join: the full rules

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

Where it's running

• Lancaster General Hospital
  Lancaster, Pennsylvania, United States Recruiting

Study contacts

• Principal investigator: Roy Small, MD — Penn Medicine / Lancaster General Hospital
• Study coordinator: Halle Becker, MPH
• Email: Halle.Becker@pennmedicine.upenn.edu
• Phone: 717-544-1777

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.