Artificial Intelligence ECG with Consumer-Facing ECG Devices for Detection of Hypertrophic Cardiomyopathy and Distinction from Athlete’s

Overview

About this study

The purpose of this study is to evaluate the AI-ECG algorithm for HCM in detecting HCM and in differentiating it from athlete’s heart using not only the standard 12-lead ECG, but also ECGs obtained with the Apple Watch and Alivecor KardiaMobile devices as well as the EKO stethoscope (ECG and phonogram).

Aims:

  1. To perform a prospective validation of the diagnostic performance of our AI-ECG algorithm for HCM using ECG recordings obtained with the Apple Watch, Alivecor KardiaMobile 6L.  
  2. To compare the diagnostic performance of AI-ECG algorithms using ECG tracings acquired via various form factors.
  3. To evaluate the HCM and low ejection fraction AI-ECG algorithm in subjects as athlete’s (using standard 12L and mobile form factors)
  4. To determine patient-specific factors associated with false negative AI-ECG results with each of the different form factors.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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 speciality 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.

Eligibility last updated 7/27/23. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Konstantinos Siontis, M.D.

Open for enrollment

Contact information:

Shaun Crawford CRAT

(507) 422-5666

Crawford.Shaun@mayo.edu

More information

Publications

Publications are currently not available