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AI ECHO INSIGHT RCT for Automated Echo Reporting

NCT07229300 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1200

Last updated 2025-11-14

No results posted yet for this study

Summary

The goal of this blinded randomized controlled trial is to assess whether AI-assisted TTE interpretation can improve cardiologist efficiency and reduce interpretation variability while preserving accuracy compared to current methods in adult patients whose historical echocardiogram images were performed.

The main questions it aims to answer is to:

1. Assess overall transthoracic echocardiogram (TTE) interpretation accuracy of an AI-assisted workflow compared to standard cardiologist-only and sonographer-assisted workflows to hypothesize if AI-assisted workflow for echocardiography interpretation is non-inferior in accuracy compared to standard workflows.
2. Evaluate cardiologist interpretation time using an AI-assisted workflow compared to standard cardiologist-only and sonographer-assisted workflows to determine if an AI-assisted workflow will result in a decrease in interpretation time compared to the cardiologist-only workflow.
3. To compare interpretation consistency and reliability compared to historical reports as well as consensus reports of all finalized cardiologist reports.

Conditions

  • Echocardiography, Transthoracic
  • Echocardiographic Software

Interventions

OTHER

AI-Assisted Echocardiogram Interpretation

Echocardiogram studies are pre-interpreted by the AI software and finalized by a blinded cardiologist.

OTHER

Sonographer-Assisted Echocardiogram Interpretation

(Standard of Care 1): Echocardiogram studies are pre-interpreted by a sonographer and finalized by a blinded cardiologist.

OTHER

Cardiologist-Only Echocardiogram Interpretation

(Standard of Care 2): Echocardiogram studies are interpreted solely by two cardiologists (one provides a preliminary interpretation another provides a blinded final interpretation).

Sponsors & Collaborators

  • Kaiser Permanente

    lead OTHER

Principal Investigators

  • David Ouyang · Kaiser Permanente

  • Keane K Lee · Kaiser Permanente

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-01
Primary Completion
2026-03-01
Completion
2026-06-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07229300 on ClinicalTrials.gov