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ENROLLING BY INVITATION
NCT07229300
NA

AI ECHO INSIGHT RCT for Automated Echo Reporting

Sponsor: Kaiser Permanente

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1200

Start Date

2025-11-01

Completion Date

2026-06-01

Last Updated

2025-11-14

Healthy Volunteers

No

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).

Locations (1)

Kaiser Permanente Northern California Division of Research

Pleasanton, California, United States