Prospective Evaluation of Artificial Intelligence ECG With Consumer-Facing ECG Devices for Detection of Hypertrophic Cardiomyopathy and Distinction From Athlete's
Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
SUMMARY
The purpose of this study is to evaluate the AI-ECG algorithm for HCM in detecting HCM and in differentiating it from athlete's using not only the standard 12-lead ECG, but also ECGs obtained with the Apple Watch and Alivecor KardiaMobile devices.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Patients with clinically validated diagnoses of HCM (n=150) and athlete's (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.
Locations
United States
Minnesota
Mayo Clinic in Rochester
RECRUITING
Rochester
Contact Information
Primary
Shaun Crawford
crawford.shaun@mayo.edu
507-422-5666
Backup
Konstantinos Siontis, MD
Siontis.Konstantinos@mayo.edu
(507) 255-1051
Time Frame
Start Date: 2024-05-07
Estimated Completion Date: 2025-12
Participants
Target number of participants: 300
Treatments
Hypertrophic Cardiomyopathy (HCM)
Subjects with clinically validated diagnoses of HCM will be enrolled and have a clinically indicated 12-Lead ECG obtained as well as ECG tracings collected using an Apple Smart Watch (single-lead) and AliveCor KardiaMobile (6-Lead).
Athlete's
Athlete's will be enrolled and have a clinically indicated 12-Lead ECG obtained as well as ECG tracings collected using an Apple Smart Watch (single-lead) and AliveCor KardiaMobile (6-Lead).
Related Therapeutic Areas
Sponsors
Leads: Mayo Clinic