Status:
COMPLETED
AI-SCREENDCM Decentralized Clinical Trial - Pilot Study
Lead Sponsor:
Mayo Clinic
Conditions:
Cardiomyopathy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 18 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 26 2025
Estimated Enrollment :
119 Patients enrolled
Trial Details
Trial ID
NCT06609174
Start Date
October 18 2024
End Date
September 26 2025
Last Update
November 4 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905