NCT07229300

AI ECHO INSIGHT RCT for Automated Echo Reporting

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

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,200 (estimated)
• Sponsor: Kaiser Permanente · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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).

Timeline

• Start date: 2025-11-01
• Primary completion: 2026-03-01
• Completion: 2026-06-01
• First posted: 2025-11-14
• Last updated: 2025-11-14

Locations

1 site across 1 country: United States