Clinical trial NCT05791227: Safety and Efficacy Study of AI Wall Thickness Measurement (EchoNet-LVH-RCT)
Official title: EchoNet-LVH-RCT: Blinded, Randomized Controlled Trial of Artificial Intelligence Guided Precision Assessment of Wall Thickness
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Heart Failure
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2023-03-30
Enrollment: 4000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Proportion of studies for which the difference in wall thickness between preliminary to overread is greater than 0.3cm for LVIDd
timeFrame: 10 Minutes
measure: Proportion of studies for which the difference in wall thickness between preliminary to overread is greater than 0.2cm for IVSd
timeFrame: 10 Minutes
measure: Proportion of studies for which the difference in wall thickness between preliminary to overread is greater than 0.2cm for LVPWd
timeFrame: 10 Minutes
measure: mean absolute error (MAE) of LVIDd between preliminary to overread between the two arms
timeFrame: 10 Minutes
measure: mean absolute error (MAE) of IVSd between preliminary to overread between the two arms
timeFrame: 10 Minutes
measure: mean absolute error (MAE) of LVPWd between preliminary to overread between the two arms
timeFrame: 10 Minutes
Secondary outcomes:
measure: mean absolute error (MAE) of wall thickness between cardiologist overread vs. historical clinical report wall thickness
timeFrame: 10 Minutes
measure: Time to complete each imaging study
timeFrame: 10 Minutes
measure: Effects of the AI systems integration with computer-human interaction (Blinding)
timeFrame: 10 Minutes
Other outcomes:
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