Actively Recruiting
Dilated Cardiomyopathy Detection Using Artificial Intelligence and Screening With Mobile Technology
Led by Lancaster General Hospital · Updated on 2025-01-30
150
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
L
Lancaster General Hospital
Lead Sponsor
M
Mayo Clinic
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the use of an Artificial Intelligence (AI) enhanced 6-lead mobile electrocardiogram (EKG) to encourage first-degree relatives of people with dilated cardiomyopathy (DCM) to get proper heart screening. This study focuses on relatives of patients with DCM, a heart condition involving reduced left ventricular function, by using a handheld device that records EKGs quickly and transmits the data for AI analysis. Participants include probands with DCM and their first-degree relatives. The study uses the AliveCor KardiaMobile 6L device, which connects wirelessly to a smartphone or tablet to capture heart signals. The AI analyzes these signals to predict reduced heart function. Probands' clinical 12-lead EKGs, if available within 30 days, will be compared to the AI results. Relatives are encouraged to follow heart screening guidelines recommended by heart associations. During the study, participants will complete mobile EKG tests, and results will be shared electronically or verbally. Researchers will collect data on how many relatives undergo heart screening after the AI test, monitor positive AI-EKG results, and gather echocardiogram results up to six months after enrollment. The primary goal is to assess how feasible this AI screening approach is and its impact on relatives obtaining cardiac evaluations.
CONDITIONS
Brief Title
Dilated Cardiomyopathy Detection Using AI and Screening With Mobile Technology (DCM-DETECT)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female age 18 years or older
- Confirmed diagnosis of non-ischemic dilated cardiomyopathy with left ventricular ejection fraction 45% or less at any time
- Must have at least one living adult first-degree relative
- Able to provide informed consent
- First-degree relatives aged 18 years or older of patients with dilated cardiomyopathy
- Proband has provided informed consent
- First-degree relatives able to provide informed verbal consent
- Access to a smartphone or tablet with cellular data or Wi-Fi
You will not qualify if you...
- Dilated cardiomyopathy due to secondary causes as determined by the investigator
- Proband has already informed first-degree relatives to undergo cardiac screening
- Ischemic causes of reduced heart function, including myocardial infarction or significant coronary artery disease
- Moderate or greater primary valve disease not caused by cardiomyopathy
- Congenital structural heart disease
- Severe untreated or untreatable high blood pressure
- Cardiomyopathy from reversible conditions such as thyroid disorders, tachyarrhythmias, or iron overload
- Secondary causes of reduced heart function such as pregnancy, myocarditis, amyloidosis, sarcoidosis, or toxin exposure
- Participants residing outside the travel range (for Central Pennsylvania Clinic participants)
- First-degree relatives previously informed or having completed heart screening
- First-degree relatives previously diagnosed with reduced heart function
- First-degree relatives residing outside the travel range (for Central Pennsylvania Clinic participants)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote)
Duration - Up to 6 months post enrollment
Participants undergo mobile 6Lead AI-enhanced EKG screening using a handheld device to detect heart function issues and are encouraged to pursue further cardiac screening per guidelines.
Initial EKG recording and follow-up communication of results; additional cardiac screening as recommended
Trial Site Locations
Total: 1 location
1
Lancaster General Hospital
Lancaster, Pennsylvania, United States, 17602
Actively Recruiting
Research Team
H
Halle Becker, MPH
J
Jonathan Derr, MBA
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SCREENING
Number of Arms
1
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