AI-SCREENDCM Decentralized Clinical Trial - Pilot Study

Launched by MAYO CLINIC · Sep 20, 2024

Keywords

ClinConnect Summary

The AI-SCREENDCM study is a clinical trial designed to explore a new way to screen individuals who are first-degree relatives (like children or siblings) of patients diagnosed with dilated cardiomyopathy (DCM), a heart condition that affects how well the heart pumps blood. The study will use a mobile device to take heart readings (an ECG) that can be sent over the internet for analysis by artificial intelligence (AI) to check for a specific issue known as reduced left ventricular ejection fraction (LVEF). This means the study aims to see if using this technology can help find heart problems earlier and improve how patients receive care.

To participate, you need to be at least 18 years old and either diagnosed with DCM or a first-degree relative of someone with this diagnosis. You’ll also need to have a smartphone or tablet with internet access. If you join the study, you will undergo a heart screening using the mobile device, and your results will be analyzed using advanced AI technology. This trial is currently recruiting participants, and if you think you might be eligible, it could be a great opportunity to contribute to important research that could help many families affected by heart disease.

Gender

ALL

Eligibility 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