Safety and Efficacy Study of AI LVEF

Study Overview
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Brief Summary
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To determine whether an integrated AI decision support can save time and improve accuracy of assessment of echocardiograms, the investigators are conducting a blinded, randomized controlled study of AI guided measurements of left ventricular ejection fraction compared to sonographer measurements in preliminary readings of echocardiograms.

Official Title
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Blinded Randomized Controlled Trial of Artificial Intelligence Guided Assessment of Cardiac Function

Conditions
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Heart Failure, Systolic, Heart Failure, Diastolic

Intervention / Treatment
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* Other: Automated annotation of the left ventricle through deep learning
* Other: Sonographer Measurement of LVEF


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The study imaging studies will include patients who underwent imaging (limited or comprehensive transthoracic echocardiogram studies) and a LVEF was adjudicated in the echocardiography/non-invasive cardiac imaging laboratory. The study participants are cardiologists reading in the echocardiography/non-invasive cardiac imaging laboratory. Exclusion Criteria: The study imaging studies will exclude transesophageal echocardiogram imaging. The study will exclude cardiologists who decline to participate

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 110 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Studies will be randomized 1:1 to either sonographer preliminary report finding or AI preliminary report finding with final adjudication by the cardiologist. With AI preliminary report, the preliminary interpretations will be generated by AI (artificial intelligence) technology [a semantic segmentation model] and the PACS system's native EF calculation workflow will be used to calculate LVEF. The study team will assess how much cardiologists edit and change this preliminary interpretation is from the final interpretation.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sonographer Annotation<br>Currently, sonographer technicians provide preliminary interpretations prior to validation and overreading by cardiologists. This staggered, stepwise evaluation allows for the introduction of AI decision support with minimal impact on patient care. Physicians are already used to adjusting the preliminary report given the variable training of sonographers and on the lookout for changes, variation, or adjustments that need to be made. | Other: Sonographer Measurement of LVEF<br>* Standard practice sonographer measurement of left ventricle and assessment of LVEF<br>|
| Experimental: Artificial Intelligence Annotation<br>In preliminary work, a novel AI algorithm developed to assess LVEF was shown to be more precise than human interpretation in 10,030 echocardiograms done at Stanford University (Ouyang et al. Nature, 2020). With randomization, a proportion of the preliminary interpretations will be done by AI technology and the study team will assess how different this preliminary interpretation is from the final interpretation. | Other: Automated annotation of the left ventricle through deep learning<br>* A semantic segmentation deep learning model will identify the left ventricle and label the left ventricle. The AI model will produce an assessment of LVEF using video based features.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of >5% change in LVEF between preliminary and final report | Proportion of studies the LVEF is changed more than 5% in final report | 10 Minutes | 
| Average change in LVEF between preliminary and final report | Mean change in LVEF between preliminary and final report | 10 Minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency cardiologist adjusts preliminary annotation | Proportion of studies the annotation is changed | 10 Minutes | 
| Average change in LVEF between prior clinical report and final report | Mean change in LVEF between prior clinical report and final report | 10 Minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Echocardiogram, Artificial Intelligence