Using AI to analyze ECGs for detecting Hypertrophic Cardiomyopathy and differentiating it from athlete's heart
Prospective Evaluation of Artificial Intelligence ECG With Consumer-Facing ECG Devices for Detection of Hypertrophic Cardiomyopathy and Distinction From Athlete's Heart
This study is testing if an AI program can help doctors better identify Hypertrophic Cardiomyopathy and tell it apart from athlete's heart using regular and consumer ECG devices.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT06290570 on ClinicalTrials.gov |
What this trial studies
This study evaluates an artificial intelligence algorithm designed to analyze electrocardiograms (ECGs) for the detection of Hypertrophic Cardiomyopathy (HCM) and to distinguish it from athlete's heart. The research utilizes standard 12-lead ECGs as well as ECGs obtained from consumer devices like the Apple Watch and AliveCor KardiaMobile. By comparing these different ECG methods, the study aims to improve diagnostic accuracy for these conditions. Participants will include patients with clinically validated diagnoses of HCM and athlete's heart, ensuring robust data collection.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with clinically validated diagnoses of Hypertrophic Cardiomyopathy or athlete's heart.
Not a fit: Patients without a confirmed diagnosis of Hypertrophic Cardiomyopathy or athlete's heart will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the accuracy of diagnosing Hypertrophic Cardiomyopathy, leading to better patient management and outcomes.
How similar studies have performed: Other studies have shown promise in using AI for ECG analysis, but this specific approach of differentiating HCM from athlete's heart is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with clinically validated diagnoses of HCM (n=150) and athlete's heart (n=150) will be identified by pre-screening of the clinic appointments for each of the specialty HCM and Sports Cardiology clinics or in the CV fellows' clinic (in patients with an established diagnosis and no pending testing). All diagnoses will need to be supported by unequivocal imaging and other ancillary data per our standard of care and at the determination of clinic experts. Exclusion Criteria: * Any exception to the above criteria.
Where this trial is running
Rochester, Minnesota
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Konstantinos Siontis, MD — Mayo Clinic
- Study coordinator: Heart Rhythm Services Research Team
- Phone: (507) 255-0774
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.