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Hypertrophic Cardiomyopathy (HCM) for Athlete's Heart

N/A
Recruiting
Led By Konstantinos Siontis, MD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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 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.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline
Awards & highlights

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 heart using not only the standard 12-lead ECG, but also ECGs obtained with the Apple Watch and Alivecor KardiaMobile devices.

Eligible Conditions
  • Athlete's Heart
  • Hypertrophic Cardiomyopathy

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Comparative diagnostic performance between tracings obtained from different devices
Distribution of AI-ECG probabilities in HCM
Secondary outcome measures
Correlation with false negative AI ECG result
Distribution of AI-ECG probabilities in Athlete's Heart

Trial Design

2Treatment groups
Experimental Treatment
Group I: Hypertrophic Cardiomyopathy (HCM)Experimental Treatment3 Interventions
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).
Group II: Athlete's HeartExperimental Treatment3 Interventions
Subjects with clinically validated diagnoses of Athlete's Heart 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
First Studied
Drug Approval Stage
How many patients have taken this drug
12-Lead ECG
2018
Completed Phase 1
~660

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,255 Previous Clinical Trials
3,835,106 Total Patients Enrolled
Konstantinos Siontis, MDPrincipal InvestigatorMayo Clinic
1 Previous Clinical Trials
8 Total Patients Enrolled
~200 spots leftby Sep 2025
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