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

NCT06290570 | Active Not Recruiting

• 1 other identifier: 23-007685
• Study Type: observational
• Target: 183
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypertrophic Cardiomyopathy

Outcome Measures

Primary Outcomes (2)

• Distribution of AI-ECG probabilities in HCM

  Artificial Intelligence (AI) scores will be measured using the AI Algorithm on ECG tracings obtained from clinically indicated 12-Lead ECG, Apple Smart Watch (single-lead), and AliveCor KardiaMobile (6-Lead) in subjects with HCM. The AI scores will be utilized to generate the AI-ECG probability of accurately diagnosing HCM (labelled as true positive, true negative, false positive, false negative) and the distribution of AI-ECG probabilities will be evaluated. A higher distribution of AI-ECG probabilities (more true positives) will reflect better diagnostic performance of the AI-ECG Algorithm.

  Baseline

• Comparative diagnostic performance between tracings obtained from different devices

  Artificial Intelligence (AI) scores will be measured using the AI Algorithm on ECG tracings obtained from clinically indicated 12-Lead ECG, Apple Smart Watch (single-lead), and AliveCor KardiaMobile (6-Lead). Diagnostic performance of AI Algorithm (labelled as true positive, true negative, false positive, false negative) based on tracing from each ECG form factor (12-lead, single-lead, 6-lead) will be evaluated and compared.

  Baseline

Secondary Outcomes (2)

• Distribution of AI-ECG probabilities in Athlete's

  Baseline

• Correlation with false negative AI ECG result

  Baseline

Study Arms (2)

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).

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

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).

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

Interventions

12-Lead ECG DIAGNOSTIC_TEST

A clinically performed 12-lead ECG tracing within 30 days of the appointment will be obtained from the subject medical record and will be used for AI-ECG analyses.

Athlete's; Hypertrophic Cardiomyopathy (HCM)

Apple Smart Watch Single Lead ECG DIAGNOSTIC_TEST

A single lead ECG tracing will be collected using an Apple Smart Watch and tracing will be used for AI-ECG analyses.

Athlete's; Hypertrophic Cardiomyopathy (HCM)

AliveCor KardiaMobile 6-Lead ECG DIAGNOSTIC_TEST

A 6-lead ECG tracing will be collected using an AliveCor KardiaMobile device and tracing will be used for AI-ECG analyses.

Athlete's; Hypertrophic Cardiomyopathy (HCM)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Outpatients scheduled for appointments in the sports cardiology or HCM clinic at Mayo Clinic in Rochester, MN will be approached to participate in the study.

You may qualify if:

• 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.

You may not qualify if:

• Any exception to the above criteria.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic

Interventions

Electrocardiography

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Study Officials

• Konstantinos Siontis, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 26, 2024
• First Posted: March 4, 2024
• Study Start: May 7, 2024
• Primary Completion: June 25, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)