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Patients who are completing an outpatient electrocardiogram (ECG) at the Mayo Clinic. for Aortic Stenosis

N/A
Waitlist Available
Led By Jae Oh, M.D.
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* Patients 18 years of age or older
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline
Awards & highlights

Summary

Two recently developed artificial intelligence-enabled electrocardiogram (AI-ECG) models have been developed to detect aortic stenosis (AS) and diastolic dysfunction (DD). AI-ECG for AS has a sensitivity of 78% and specificity of 74%, and AI-ECG for DD has a sensitivity of 83% and specificity of 80%. However, these models have never been prospectively applied to diagnose AS or DD, which may be useful for patients and providers from a diagnostic and prognostic perspective and especially in settings where access to higher- level medical care is limited. In this study, we aim to determine the clinical utility of these AI-ECG models by prospectively applying them to an outpatient cohort and then completing a focused point-of-care ultrasound to evaluate those who are AI-ECG positive for AS and DD.

Eligible Conditions
  • Aortic Stenosis
  • Diastolic Dysfunction

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of patients with positive AI-ECG
Number of studies with reasonable image quality in patients with positive AI-ECG
Secondary study objectives
Number of times the AI ECG and TTE (transthoracic echocardiogram) are statistically comparative

Trial Design

1Treatment groups
Experimental Treatment
Group I: Patients who are completing an outpatient electrocardiogram (ECG) at the Mayo Clinic.Experimental Treatment2 Interventions

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Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,298 Previous Clinical Trials
3,958,245 Total Patients Enrolled
Jae Oh, M.D.Principal InvestigatorMayo Clinic
~133 spots leftby Mar 2025