A Study Of ECG-AI Hypertrophic Cardiomyopathy Algorithm

Overview

About this study

The primary purpose of this study is to create a database that enables the validation of sequential versions of an ECG-AI algorithm designed to identify hypertrophic cardiomyopathy. The sensitivity and specificity of the hypertrophic cardiomyopathy ECG-AI algorithm will be assessed as primary endpoints. The performance will be assessed within prespecified patient subgroups, to assess the accuracy, including sensitivity and specificity, of the hypertrophic cardiomyopathy ECG-AI algorithm.

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:

  • Age >=10

  • Have at least one ECG within +/- 180 days of complete transthoracic echocardiogram (TTE) or cardiac MRI which contains the measurement of maximal wall thickness

  • Cases:

    • Clinically validated diagnosis of hypertrophic cardiomyopathy per current diagnostic guidelines

  • Normal Controls:

    • No diagnosis hypertrophic cardiomyopathy and no concern for hypertrophic cardiomyopathy from TTE or cardiac MRI

Exclusion Criteria:

  • No subject consent obtained, or no IRB waiver granted

  • Subjects who only have ECGs with signals shorter than 10 seconds or that are not interpretable

  • Additional exclusion criteria will be applied by post-data collection, using deidentified clinical data, by the analysis team. These are detailed in the statistical analysis plan.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

 

Eligibility last updated 08/12/2025. 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

Open for enrollment

Contact information:

Konstantinos Siontis

siontis.konstantinos@mayo.edu

More information

Publications

Publications are currently not available