Safety and Efficacy Study of AI Wall Thickness Measurement (EchoNet-LVH-RCT)
- Conditions
- Heart Failure
- Interventions
- Diagnostic Test: Sonographer EvaluationDiagnostic Test: AI Evaluation
- Registration Number
- NCT05791227
- Lead Sponsor
- Cedars-Sinai Medical Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 4000
- Sonographers and cardiologists at CSMC Echocardiography Lab
- All transthoracic echocardiogram studies performed in the CSMC echocardiogram lab
- transthoracic echocardiogram studies not able to be measured by sonographers in run in period
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sonographer Annotation Sonographer Evaluation 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. Artificial Intelligence Annotation AI Evaluation 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.
- Primary Outcome Measures
Name Time Method Proportion of studies for which the difference in wall thickness between preliminary to overread is greater than 0.3cm for LVIDd 10 Minutes Proportion of significant difference in LVIDd between preliminary to final assessment
Proportion of studies for which the difference in wall thickness between preliminary to overread is greater than 0.2cm for IVSd 10 Minutes Proportion of significant difference in IVSd between preliminary to final assessment
Proportion of studies for which the difference in wall thickness between preliminary to overread is greater than 0.2cm for LVPWd 10 Minutes Proportion of significant difference in LVPWd between preliminary to final assessment
mean absolute error (MAE) of IVSd between preliminary to overread between the two arms 10 Minutes Measurement difference of IVSd between preliminary to final assessment
mean absolute error (MAE) of LVPWd between preliminary to overread between the two arms 10 Minutes Measurement difference of LVPWd between preliminary to final assessment
mean absolute error (MAE) of LVIDd between preliminary to overread between the two arms 10 Minutes Measurement difference of LVIDd between preliminary to final assessment
- Secondary Outcome Measures
Name Time Method mean absolute error (MAE) of wall thickness between cardiologist overread vs. historical clinical report wall thickness 10 Minutes Mean absolute error (MAE) of wall thickness between cardiologist overread with initial interpretation vs. prior clinical report wall thickness
Time to complete each imaging study 10 Minutes Time for sonographers and cardiologists to complete a study (in seconds)
Effects of the AI systems integration with computer-human interaction (Blinding) 10 Minutes 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).