Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
NA
1200 participants
INTERVENTIONAL
2025-11-01
2026-06-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
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AI-Assisted Interpretation
In AI-prelim arm, AI provides the preliminary interpretation which is finalized by a blinded cardiologist.
AI-Assisted Echocardiogram Interpretation
Echocardiogram studies are pre-interpreted by the AI software and finalized by a blinded cardiologist.
Sonographer-Assisted Interpretation
In Sonographer-prelim arm, sonographer provides the preliminary interpretation which is finalized by a blinded cardiologist.
Sonographer-Assisted Echocardiogram Interpretation
(Standard of Care 1): Echocardiogram studies are pre-interpreted by a sonographer and finalized by a blinded cardiologist.
Cardiologist-Only Interpretation
In cardiologist-prelim arm, cardiology provides the preliminary interpretation which is finalized by a blinded separate cardiologist.
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).
Interventions
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AI-Assisted Echocardiogram Interpretation
Echocardiogram studies are pre-interpreted by the AI software and finalized by a blinded cardiologist.
Sonographer-Assisted Echocardiogram Interpretation
(Standard of Care 1): Echocardiogram studies are pre-interpreted by a sonographer and finalized by a blinded cardiologist.
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).
Eligibility Criteria
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Inclusion Criteria
* Comprehensive transthoracic echocardiogram study performed a KPNC Medical Center.
Exclusion Criteria
* Known Ventricular assist device
* Limited transthoracic echocardiogram study
* Transesophageal echocardiogram study
* Stress echocardiogram study
18 Years
ALL
No
Sponsors
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Kaiser Permanente
OTHER
Responsible Party
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David Ouyang
Principal Investigator
Principal Investigators
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David Ouyang
Role: PRINCIPAL_INVESTIGATOR
Kaiser Permanente
Keane K Lee
Role: PRINCIPAL_INVESTIGATOR
Kaiser Permanente
Locations
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Kaiser Permanente Northern California Division of Research
Pleasanton, California, United States
Countries
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Other Identifiers
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2302504
Identifier Type: -
Identifier Source: org_study_id
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