AI ECHO INSIGHT RCT for Automated Echo Reporting

Conditions

• Echocardiographic Software
• Echocardiography, Transthoracic

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• AI-Assisted Echocardiogram Interpretation — OTHER
  Echocardiogram studies are pre-interpreted by the AI software and finalized by a blinded cardiologist.
• Sonographer-Assisted Echocardiogram Interpretation — OTHER
  (Standard of Care 1): Echocardiogram studies are pre-interpreted by a sonographer and finalized by a blinded cardiologist.
• 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).

Study Details

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.

Key Dates

Start date

Nov 1, 2025

Status verified

Nov 2025

Primary completion

Mar 1, 2026

Completion

Jun 1, 2026

Study Design

Enrollment

1,200 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Arms

• Active Comparator: AI-Assisted Interpretation
  In AI-prelim arm, AI provides the preliminary interpretation which is finalized by a blinded cardiologist.
• Active Comparator: Sonographer-Assisted Interpretation
  In Sonographer-prelim arm, sonographer provides the preliminary interpretation which is finalized by a blinded cardiologist.
• Active Comparator: Cardiologist-Only Interpretation
  In cardiologist-prelim arm, cardiology provides the preliminary interpretation which is finalized by a blinded separate cardiologist.

Primary Outcome Measure

Accuracy of AI-Assisted Echocardiogram Interpretation Compared to Standard Workflows. [ Time Frame: 6 months ]

Locations (1)

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