CompletedNo phase
AI-SCREENDCM Decentralized Clinical Trial - Pilot Study
Key facts
- Who runs it
- Mayo Clinic
- Where
- Rochester, United StatesSee the site
- Trial code
- Status
- Completed
- People taking part
- 119 people enrolled
- Started
- 18 Oct 2024
- Ended
- 26 Sept 2025
- Type of study
- Interventional, 2 groups
- Treatments tested
- KardiaRx ECG Screening and AI interpretation of ECG
- Record updated
- 13 October 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 20 criteriaShow less
Who can take part
- 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
- 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
Who cannot take part
- Proband has previously informed FDR to undergo cardiac screening
- Previously informed about cardiac screening or has completed cardiac screening by TTE
- Congenital structural heart disease
- Severe and untreated or untreatable hypertension
- Cardiomyopathy due to acute or reversible conditions; examples include tachyarrhythmias, thyroid disorders, iron overload
- 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
- Any secondary cause of reduced LVEF such as peripartum cardiomyopathy, myocarditis, amyloidosis, sarcoidosis, exposure to toxins including alcohol, substance abuse or chemotherapeutic drug
- Previously diagnosed with reduced LVEF
- DCM attributed to any other secondary form of cardiomyopathy per the investigator's determination
- Moderate or greater primary valvular abnormality not due to underlying cardiomyopathy
- (CPC Participants only) Home address outside of traveling range
- (CPC Participants only) Home address outside of traveling range
Where in United States
- Mayo Clinic in RochesterRochester, United StatesNo longer taking part
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- First degree relativesTreatment being tested
Subjects who are first-degree relatives of patients with DCM
Treatment: KardiaRx ECG Screening and AI interpretation of ECG
- DCM (Dilated Cardiomyopathy) PatientsTreatment being tested
Subjects who are diagnosed with DCM (dilated cardiomyopathy).
Treatment: KardiaRx ECG Screening and AI interpretation of ECG
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Artificial Intelligence Electrocardiogram Enabled Mobile Device in Screening Families for Dilated Cardiomyopathy (The AI-SCREENDCM Decentralized Clinical Trial Pilot Study)
- Record updated
- 13 October 2026