CompletedNot Applicable

AI-SCREENDCM Decentralized Clinical Trial - Pilot Study

United States119 participantsStarted 2024-10-18

Plain-language summary

The purpose of this study is to assess the feasibility and impact of screening FDR of DCM probands using a mobile ECG with the ability to transmit the ECG for cloud-based AI analysis to detect reduced left ventricular ejection fraction (LVEF). This protocol will examine the impact of incorporating the screening AI enhanced ECG into standard of care recommendations.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of First-Degree Relatives to complete the AI-ECG

Timeframe: Baseline

Number of First-Degree relatives to complete cardiac screening

Timeframe: Baseline

Trial details

NCT IDNCT06609174

SponsorMayo Clinic

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-09-26

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