Using AI and mobile technology to screen for dilated cardiomyopathy in family members
Dilated Cardiomyopathy Detection Using Artificial Intelligence and Screening With Mobile Technology
This study is testing if using a special mobile EKG device can help family members of people with dilated cardiomyopathy get screened for heart problems more often.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Lancaster General Hospital Academic / other |
| Locations | 1 site (Lancaster, Pennsylvania) |
| Trial ID | NCT06688396 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who are first-degree relatives of patients diagnosed with dilated cardiomyopathy.
Not a fit: Patients with dilated cardiomyopathy attributed to secondary causes or those who have already been screened may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to earlier detection of dilated cardiomyopathy in at-risk family members, improving patient outcomes.
How similar studies have performed: Other studies utilizing mobile technology and AI for cardiac screening have shown promise, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Lancaster, Pennsylvania
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.