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NCT06580158 · ClinicalTrials.gov registry record

AI in Outpatient Practice for Diagnosing Aortic Stenosis and Diastolic Dysfunction

A clinical trial of Aortic Stenosis and Diastolic Dysfunction, sponsored by Mayo Clinic.

Recruiting
Registry status
2,000
Enrollment target
1
Study location

NCT06580158 is a study of Aortic Stenosis and Diastolic Dysfunction that is actively recruiting participants, run by Mayo Clinic. The registered enrollment target is 2,000 participants, above the 1,285-participant average among 26 other Aortic Stenosis trials with a reported enrollment target (56% higher). The trial reports 1 study location across 1 state.

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The verdict

NCT06580158, a study of Aortic Stenosis and Diastolic Dysfunction, is actively recruiting participants, sponsored by Mayo Clinic.

RECRUITING
Registry status
2,000 participants
Enrollment target
1
Study location

Study 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.

Interventions

  • DEVICE AI-ECG Dashboard
  • DIAGNOSTIC_TEST Point of care ultrasound (POCUS)

Study Locations (1)

Minnesota

  • Mayo Clinic - Rochester

Trial Details

FieldValue
Enrollment Target 2,000 participants
Start Date 2024-11-08
Est. Completion 2027-03

Sponsor

Mayo Clinic

2,844 total trials

What the Registry Record Tells You About NCT06580158

The ClinicalTrials.gov registry entry for NCT06580158 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 2,000 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 1,285-participant average among 26 other Aortic Stenosis trials with a reported enrollment target (56% higher). The listed sponsor is Mayo Clinic, which has 2,844 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Aortic Stenosis appearing as the primary indexed condition, and to 2 interventions - of which AI-ECG Dashboard is the first listed.

NCT06580158 reports 1 study location spanning 1 distinct geographic area - top geographies include Minnesota.

Frequently Asked Questions

What is clinical trial NCT06580158 about?

NCT06580158 is a clinical study titled "AI in Outpatient Practice for Diagnosing Aortic Stenosis and Diastolic Dysfunction". 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%...

What is the current status of trial NCT06580158?

This trial is currently recruiting. The enrollment target is 2,000 participants. The study started on 2024-11-08. Estimated completion is 2027-03.

What conditions does trial NCT06580158 study?

This clinical trial studies the following conditions: Aortic Stenosis, Diastolic Dysfunction.

What interventions are being tested in trial NCT06580158?

The interventions under investigation include: AI-ECG Dashboard (DEVICE), Point of care ultrasound (POCUS) (DIAGNOSTIC_TEST).

Who is sponsoring clinical trial NCT06580158?

This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06580158 being conducted?

This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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