AI ECHO INSIGHT RCT for Automated Echo Reporting (AI INSIGHT)

November 13, 2025 updated by: David Ouyang, Kaiser Permanente

Artificial Intelligence Echocardiogram Interpretation for Systematic Integration and Guided Healthcare Transformation (The AI ECHO INSIGHT Study)

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Pleasanton, California, United States, 94588
        • Kaiser Permanente Northern California Division of Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • ≥ 18 years of age
  • Comprehensive transthoracic echocardiogram study performed a KPNC Medical Center.

Exclusion Criteria:

  • Known Congenital heart disease study
  • Known Ventricular assist device
  • Limited transthoracic echocardiogram study
  • Transesophageal echocardiogram study
  • Stress echocardiogram study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: AI-Assisted Interpretation
In AI-prelim arm, AI provides the preliminary interpretation which is finalized by a blinded cardiologist.
Other: AI-Assisted Echocardiogram Interpretation
Echocardiogram studies are pre-interpreted by the AI software and finalized by a blinded cardiologist.
Active Comparator: Sonographer-Assisted Interpretation
In Sonographer-prelim arm, sonographer provides the preliminary interpretation which is 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.
Active Comparator: Cardiologist-Only Interpretation
In cardiologist-prelim arm, cardiology provides the preliminary interpretation which is finalized by a blinded separate 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy of AI-Assisted Echocardiogram Interpretation Compared to Standard Workflows.
Time Frame: 6 months

The accuracy rate is defined as the proportion of transthoracic echocardiogram (TTE) studies for which the final cardiologist interpretation is not significantly different from the preliminary interpretation. We will assess the accuracy rate in the AI-assisted arm for non-inferiority versus the pooled accuracy rate across both the sonographer-assisted and cardiologist-only arms.

The investigators will measure the proportion of TTE studies for which the final cardiologist report is substantially different from the preliminary report (e.g., the rate of substantial change). We define a TTE report to be substantially different from another TTE interpretation if any of its key elements are substantially different (LVEF, right ventriuclar function, chamber size, valvular regurgitation severity, valvular stenosis severity, and right ventricular systolic pressure).
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary Measures of Accuracy (Superiority Analyses)
Time Frame: 6 months

Accuracy rates will also be analyzed for superiority rather than non-inferiority. The proportion of TTE studies for which the final cardiologist interpretation is not significantly different from the preliminary interpretation will be compared individually between the AI-assisted arm and each comparator arm (sonographer-assisted and cardiologist-only).

  1. AI-prelim workflow vs. pooled sonographer-prelim and cardiologist-prelim workflow with a superiority test
  2. AI-prelim workflow vs. sonographer-prelim workflow with a superiority test
  3. AI-prelim workflow vs. cardiologist-prelim workflow with a superiority test
6 months
Accuracy Compared with Historical Cardiologist Interpretations
Time Frame: 6 months
Accuracy is defined as the proportion of TTE studies for which the final cardiologist report is substantially different from the historical report (e.g., the rate of substantial change). We define a TTE report to be substantially different from another TTE interpretation if any of its key elements are substantially different (LVEF, right ventriuclar function, chamber size, valvular regurgitation severity, valvular stenosis severity, and right ventricular systolic pressure).
6 months
Accuracy Compared with Consensus Cardiologist Interpretations
Time Frame: 6 months
Accuracy is defined as the proportion of TTE studies for which the consensus cardiologist report is substantially different from the preliminary report (e.g., the rate of substantial change). We define a TTE report to be substantially different from another TTE interpretation if any of its key elements are substantially different (LVEF, right ventriuclar function, chamber size, valvular regurgitation severity, valvular stenosis severity, and right ventricular systolic pressure).
6 months
Evaluation requiring two-grade change in valve disease severity as substantial change
Time Frame: 6 months

Accuracy is defined asthe proportion of TTE studies for which the final cardiologist report is substantially different from the preliminary report (e.g., the rate of substantial change). We define a TTE report to be substantially different from another TTE interpretation if any of its key elements are substantially different (LVEF, right ventricular function, chamber size, valvular regurgitation severity, valvular stenosis severity, and right ventricular systolic pressure).

  1. AI-prelim workflow vs. pooled sonographer-prelim and cardiologist-prelim workflow with a superiority test
  2. AI-prelim workflow vs. sonographer-prelim workflow with a superiority test
  3. AI-prelim workflow vs. cardiologist-prelim workflow with a superiority test
6 months
Cardiologist Overread Time (Efficiency)
Time Frame: 6 months

To assess whether AI-assisted interpretation saves time, the investigators will compare the mean time in seconds required for the cardiologist to complete the overreading process across the three arms (i.e., TTE interpretation workflows) in our trial. Specifically, we will perform the following comparisons:

  1. The mean cardiologist overread time in the AI-assisted arm versus the pooled results of the sonographer-assisted and cardiologist-only arms
  2. The mean cardiologist overread time in the AI-assisted arm versus the sonographer-assisted arm
  3. The mean cardiologist overread time in the AI-assisted arm versus the cardiologist-only arm
6 months
Comparison of Existing Standards of Care (Sonographer-Assisted vs Cardiologist-Only)
Time Frame: 6 months
The investigators will measure the proportion of TTE studies for which the final cardiologist report is substantially different from the preliminary report (e.g., the rate of substantial change) in sonographer-prelim and cardiologist-prelim arms. We define a TTE report to be substantially different from another TTE interpretation if any of its key elements are substantially different (LVEF, right ventricular function, chamber size, valvular regurgitation severity, valvular stenosis severity, and right ventricular systolic pressure).
6 months
Blinding
Time Frame: 6 months
In each of the arms, at the completion of each study for the final cardiologist assessment, the cardiologist will be asked to guess whether the preliminary assessment was AI or human. This will be used to calculate a blinding index comparing the AI-prelim arm vs. a composite of the two standard of care arms, as well as comparing the AI-prelim arm with the sonographer-prelim arm individually and comparing the AI-prelim arm with the cardiologist-prelim arm individually.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaiser Permanente

Investigators

  • Principal Investigator: David Ouyang, Kaiser Permanente
  • Principal Investigator: Keane K Lee, Kaiser Permanente

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2025

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

November 12, 2025

First Submitted That Met QC Criteria

November 13, 2025

First Posted (Estimated)

November 14, 2025

Study Record Updates

Last Update Posted (Estimated)

November 14, 2025

Last Update Submitted That Met QC Criteria

November 13, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2302504

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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