Using AI to screen family members of patients with cardiomyopathy
Artificial Intelligence Electrocardiogram Enabled Mobile Device in Screening Families for Dilated Cardiomyopathy (The AI-SCREENDCM Decentralized Clinical Trial Pilot Study)
This study is testing if using a mobile ECG device with AI can help find heart problems in family members of people with dilated cardiomyopathy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT06609174 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to evaluate the feasibility and effectiveness of using a mobile ECG device combined with cloud-based AI analysis to screen first-degree relatives of patients diagnosed with dilated cardiomyopathy (DCM). The study will focus on detecting reduced left ventricular ejection fraction (LVEF) in these relatives, assessing how the integration of AI-enhanced ECG screening can improve standard care recommendations. Participants will include both probands with confirmed DCM and their first-degree relatives who meet specific eligibility criteria.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who are first-degree relatives of patients with a confirmed diagnosis of dilated cardiomyopathy.
Not a fit: Patients with DCM due to secondary causes or those who have already undergone cardiac screening may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to earlier detection and management of cardiomyopathy in at-risk family members.
How similar studies have performed: While the use of AI in cardiology is gaining traction, this specific approach to screening family members of DCM patients is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria (Proband) * Male or female age ≥ 18 years * Confirmed diagnosis of 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 ≥ 18 years 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 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, NSTEMI or unstable angina) revascularization or ≥75% stenosis of either left main or 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 TTE * Previously diagnosed with reduced LVEF * (CPC Participants only) Home address outside of traveling range
Where this trial is running
Rochester, Minnesota
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Naveen Pereira, M.D. — Mayo Clinic
- Study coordinator: Brendan Mark
- Email: Mark.Brendan@mayo.edu
- Phone: 507-284-4284
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.