A Study of Artificial Intelligence ECG With ECG Devices to Detect Hypertrophic Cardiomyopathy Distinct From Athlete's

Mayo Clinic

Status: Enrolling

Conditions: Hypertrophic Cardiomyopathy

Treatments: Diagnostic Test: AliveCor KardiaMobile 6-Lead ECG; Diagnostic Test: Apple Smart Watch Single Lead ECG; Diagnostic Test: 12-Lead ECG

Study type: Observational

Funder types: Other

Identifiers

NCT06290570

23-007685

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• Any exception to the above criteria.

Trial design

300 participants in 2 patient groups

Hypertrophic Cardiomyopathy (HCM)

Description:

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).

Treatment:

Diagnostic Test: 12-Lead ECG

Diagnostic Test: AliveCor KardiaMobile 6-Lead ECG

Diagnostic Test: Apple Smart Watch Single Lead ECG

Athlete's

Description:

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).

Treatment:

Diagnostic Test: 12-Lead ECG

Diagnostic Test: AliveCor KardiaMobile 6-Lead ECG

Diagnostic Test: Apple Smart Watch Single Lead ECG