AI ECHO INSIGHT RCT for Automated Echo Reporting

NCT07229300 | Enrolling By Invitation

• 1 other identifier: 2302504
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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. 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

Keywords

Echocardiography Interpretation

Outcome Measures

Primary Outcomes (1)

• Accuracy of AI-Assisted Echocardiogram Interpretation Compared to Standard Workflows.

  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 Outcomes (7)

• Secondary Measures of Accuracy (Superiority Analyses)

  6 months

• Accuracy Compared with Historical Cardiologist Interpretations

  6 months

• Accuracy Compared with Consensus Cardiologist Interpretations

  6 months

• Evaluation requiring two-grade change in valve disease severity as substantial change

  6 months

• Cardiologist Overread Time (Efficiency)

  6 months

Study Arms (3)

AI-Assisted Interpretation

ACTIVE COMPARATOR

In AI-prelim arm, AI provides the preliminary interpretation which is finalized by a blinded cardiologist.

Other: AI-Assisted Echocardiogram Interpretation

Sonographer-Assisted Interpretation

ACTIVE COMPARATOR

In Sonographer-prelim arm, sonographer provides the preliminary interpretation which is finalized by a blinded cardiologist.

Other: Sonographer-Assisted Echocardiogram Interpretation

Cardiologist-Only Interpretation

ACTIVE COMPARATOR

In cardiologist-prelim arm, cardiology provides the preliminary interpretation which is finalized by a blinded separate cardiologist.

Other: Cardiologist-Only Echocardiogram Interpretation

Interventions

AI-Assisted Echocardiogram Interpretation OTHER

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

AI-Assisted Interpretation

Sonographer-Assisted Echocardiogram Interpretation OTHER

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

Sonographer-Assisted Interpretation

Cardiologist-Only Echocardiogram Interpretation OTHER

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

Cardiologist-Only Interpretation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Kaiser Permanente: lead

Study Sites (1)

Kaiser Permanente Northern California Division of Research

Pleasanton, California, 94588, United States

Location

Study Officials

• David Ouyang

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

• Keane K Lee

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 12, 2025
• First Posted: November 14, 2025
• Study Start: November 1, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: November 14, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

US (1)