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AI in Outpatient Practice for Diagnosing Aortic Stenosis and Diastolic Dysfunction

NCT ID: NCT06580158

Last Updated: 2024-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-11-08

Study Completion Date

2026-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Aortic Stenosis Diastolic Dysfunction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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

AI-ECG Dashboard

Intervention Type DEVICE

Patients standard of care ECG's will be processed through the AI-ECG Dashboard

Point of care ultrasound (POCUS)

Intervention Type DIAGNOSTIC_TEST

Patients will undergo a ultrasound to confirm diagnosis of atrial stenosis or diastolic dysfunction.

Interventions

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AI-ECG Dashboard

Patients standard of care ECG's will be processed through the AI-ECG Dashboard

Intervention Type DEVICE

Point of care ultrasound (POCUS)

Patients will undergo a ultrasound to confirm diagnosis of atrial stenosis or diastolic dysfunction.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* ≥ 60 years of age must have a clinical scheduled ECG performed.

Exclusion Criteria

* \< 59 years of age
* Is not scheduled for a clinical ECG
* Unable to provide consent.
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Jae K. Oh, M.D.

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jae Oh, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic

Rochester, Minnesota, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Levi Disrud

Role: CONTACT

Phone: 507-422-5241

Email: [email protected]

Jae Oh, M.D.

Role: CONTACT

Email: [email protected]

Facility Contacts

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Jae Oh, M.D.

Role: primary

Other Identifiers

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24-000100

Identifier Type: -

Identifier Source: org_study_id