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

Mayo Clinic300 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

300

Conditions

Hypertrophic Cardiomyopathy

Interventions

12-Lead ECGDIAGNOSTIC_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.

Apple Smart Watch Single Lead ECGDIAGNOSTIC_TEST

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

AliveCor KardiaMobile 6-Lead ECGDIAGNOSTIC_TEST

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: Baseline

Secondary Outcomes

Distribution of AI-ECG probabilities in Athlete's

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 Athlete's. The AI scores will be utilized to generate the AI-ECG probability of accurately diagnosing HCM (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.

Time frame: Baseline

Correlation with false negative AI ECG result

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 the correlation of the form factor to a false negative AI ECG result will be determined.

Central Contacts

Shaun Crawford

CONTACT

507-422-5666 crawford.shaun@mayo.edu

Konstantinos Siontis, MD

CONTACT

(507) 255-1051 Siontis.Konstantinos@mayo.edu

Data from ClinicalTrials.gov

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