AI INSIGHT
Artificial Intelligence Echocardiogram Interpretation for Systematic Integration and Guided Healthcare Transformation (The AI ECHO INSIGHT Study)
Sponsor study identifier
interventional
1,200
1 country
1
Study Start
November 1, 2025
Actual (reported)Primary Completion
August 1, 2026
Actual (reported)Study Completion
August 20, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 20, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 1, 2025
Actual (reported)November 12, 2025
Actual (reported)November 14, 2025
Actual (reported)August 1, 2026
Actual (reported)August 20, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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 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
In AI-prelim arm, AI provides the preliminary interpretation which is finalized by a blinded cardiologist.
In Sonographer-prelim arm, sonographer provides the preliminary interpretation which is finalized by a blinded cardiologist.
In cardiologist-prelim arm, cardiology provides the preliminary interpretation which is finalized by a blinded separate cardiologist.
Echocardiogram studies are pre-interpreted by the AI software and finalized by a blinded cardiologist.
(Standard of Care 1): Echocardiogram studies are pre-interpreted by a sonographer and finalized by a blinded cardiologist.
Kaiser Permanente Northern California Division of Research
Pleasanton, California, 94588, United States
Lee KK, Kumar N, Eusuff S, Vukadinovic M, Ieki H, Moore MJ, Ambrosy AP, Go AS, Jang J, Dinh H, Ku IA, Liu V, Ouyang D, Claggett B, He B. AI echo INSIGHT study: A prospective blinded randomized trial of artificial intelligence echocardiogram interpretation. Contemp Clin Trials. 2026 Aug 9:108431. doi: 10.1016/j.cct.2026.108431. Online ahead of print.
Keane K Lee
Kaiser Permanente
First Submitted
November 12, 2025
First Posted
November 14, 2025
Study Start
November 1, 2025
Actual (reported)Primary Completion
August 1, 2026
Actual (reported)Cardiac Output in Preeclamptic
(Standard of Care 2): Echocardiogram studies are interpreted solely by two cardiologists (one provides a preliminary interpretation another provides a blinded final interpretation).
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Study Completion
August 20, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
August 6, 2026
Record last verified: 2026-08
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Source: ClinicalTrials.gov.
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