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Enrolling by invitation NCT07229300

AI ECHO INSIGHT RCT for Automated Echo Reporting

No phase Interventional Echocardiography, Transthoracic Echocardiographic Software

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: AI-Assisted Echocardiogram Interpretation, Sonographer-Assisted Echocardiogram Interpretation, Cardiologist-Only Echocardiogram Interpretation.
Who it may be relevant to
Registry conditions: Echocardiography, Transthoracic, Echocardiographic Software. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

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).

Primary outcome measures

  • Accuracy of AI-Assisted Echocardiogram Interpretation Compared to Standard Workflows. [Time frame: 6 months]
Secondary outcome measures (7)
  • Secondary Measures of Accuracy (Superiority Analyses) [Time frame: 6 months]
  • Accuracy Compared with Historical Cardiologist Interpretations [Time frame: 6 months]
  • Accuracy Compared with Consensus Cardiologist Interpretations [Time frame: 6 months]
  • Evaluation requiring two-grade change in valve disease severity as substantial change [Time frame: 6 months]
  • Cardiologist Overread Time (Efficiency) [Time frame: 6 months]
  • Comparison of Existing Standards of Care (Sonographer-Assisted vs Cardiologist-Only) [Time frame: 6 months]
  • Blinding [Time frame: 6 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Diagnostic

Study locations

United States · 1 center
  • Kaiser Permanente Northern California Division of Research — Pleasanton

Identifiers

NCT: NCT07229300 · 2302504

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗