Safety and Efficacy Study of AI Wall Thickness Measurement (EchoNet-LVH-RCT)

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 wall thickness in parasternal long axis view compared to sonographer measurements in preliminary readings of echocardiograms.

Official Title
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EchoNet-LVH-RCT: Blinded, Randomized Controlled Trial of Artificial Intelligence Guided Precision Assessment of Wall Thickness

Conditions
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Heart Failure

Intervention / Treatment
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* Diagnostic Test: Sonographer Evaluation
* Diagnostic Test: AI Evaluation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Sonographers and cardiologists at CSMC Echocardiography Lab All transthoracic echocardiogram studies performed in the CSMC echocardiogram lab Exclusion Criteria: transthoracic echocardiogram studies not able to be measured by sonographers in run in period

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 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: Parallel 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 reporting workflow will be used visualize measurements of left ventricular diameter during diastole (LVIDd), intraventricular septum thickness during diastole (IVSd) and left ventricular posterior wall thickness during diastole (LVPWd). The study team will assess how much cardiologists edit and change this preliminary interpretation is from the final interpretation.
Masking: Triple


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. | Diagnostic Test: Sonographer Evaluation<br>* A sonographer will assess measurements of left ventricular diameter during diastole (LVIDd), intraventricular septum thickness during diastole (IVSd) and left ventricular posterior wall thickness during diastole (LVPWd).<br>|
| Experimental: Artificial Intelligence Annotation<br>A novel AI algorithm developed to assess measurements of left ventricular diameter during diastole (LVIDd), intraventricular septum thickness during diastole (IVSd) and left ventricular posterior wall thickness during diastole (LVPWd). The AI will provide preliminary assessments for cardiologist evaluation. | Diagnostic Test: AI Evaluation<br>* An AI model will assess measurements of left ventricular diameter during diastole (LVIDd), intraventricular septum thickness during diastole (IVSd) and left ventricular posterior wall thickness during diastole (LVPWd).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of studies for which the difference in wall thickness between preliminary to overread is greater than 0.3cm for LVIDd | Proportion of significant difference in LVIDd between preliminary to final assessment | 10 Minutes | 
| Proportion of studies for which the difference in wall thickness between preliminary to overread is greater than 0.2cm for IVSd | Proportion of significant difference in IVSd between preliminary to final assessment | 10 Minutes | 
| Proportion of studies for which the difference in wall thickness between preliminary to overread is greater than 0.2cm for LVPWd | Proportion of significant difference in LVPWd between preliminary to final assessment | 10 Minutes | 
| mean absolute error (MAE) of LVIDd between preliminary to overread between the two arms | Measurement difference of LVIDd between preliminary to final assessment | 10 Minutes | 
| mean absolute error (MAE) of IVSd between preliminary to overread between the two arms | Measurement difference of IVSd between preliminary to final assessment | 10 Minutes | 
| mean absolute error (MAE) of LVPWd between preliminary to overread between the two arms | Measurement difference of LVPWd between preliminary to final assessment | 10 Minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean absolute error (MAE) of wall thickness between cardiologist overread vs. historical clinical report wall thickness | Mean absolute error (MAE) of wall thickness between cardiologist overread with initial interpretation vs. prior clinical report wall thickness | 10 Minutes | 
| Time to complete each imaging study | Time for sonographers and cardiologists to complete a study (in seconds) | 10 Minutes | 
| Effects of the AI systems integration with computer-human interaction (Blinding) | Whether cardiologists can tell the difference between human vs. AI initial interpretation (Bang's blinding index, or the proportion of studies guessed correctly to be AI or sonographer compared to ground truth of whether it was AI or sonographer). | 10 Minutes |