Heart Failure Clinical Trial
Official title:
EchoNet-LVH-RCT: Blinded, Randomized Controlled Trial of Artificial Intelligence Guided Precision Assessment of Wall Thickness
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.
Status | Not yet recruiting |
Enrollment | 4000 |
Est. completion date | November 1, 2024 |
Est. primary completion date | November 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
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Cedars-Sinai Medical Center |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | 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 | |
Secondary | Time to complete each imaging study | Time for sonographers and cardiologists to complete a study (in seconds) | 10 Minutes | |
Secondary | 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 |
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