Heart Failure
Conditions
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.
Interventions
DIAGNOSTIC_TESTSonographer Evaluation
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).
DIAGNOSTIC_TESTAI Evaluation
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).
Sponsors
Cedars-Sinai Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Measurements shown in Picture Archiving and Communication System (PACS) without direct communication between sonographer and cardiologist. Annotations are shown without identifiers on how the annotations were done. Cardiologists are blinded to source of preliminary interpretation.
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 LVIDd between preliminary to overread between the two arms | 10 Minutes | Measurement difference of LVIDd 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
United States
Outcome results
None listed