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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 left ventricular ejection fraction compared to sonographer measurements in preliminary readings of echocardiograms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sonographer Annotation | Active Comparator | 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. |
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| Artificial Intelligence Annotation | Experimental | In preliminary work, a novel AI algorithm developed to assess LVEF was shown to be more precise than human interpretation in 10,030 echocardiograms done at Stanford University (Ouyang et al. Nature, 2020). With randomization, a proportion of the preliminary interpretations will be done by AI technology and the study team will assess how different this preliminary interpretation is from the final interpretation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Automated annotation of the left ventricle through deep learning | Other | A semantic segmentation deep learning model will identify the left ventricle and label the left ventricle. The AI model will produce an assessment of LVEF using video based features. |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of >5% change in LVEF between preliminary and final report | Proportion of studies the LVEF is changed more than 5% in final report | 10 Minutes |
| Average change in LVEF between preliminary and final report | Mean change in LVEF between preliminary and final report | 10 Minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency cardiologist adjusts preliminary annotation | Proportion of studies the annotation is changed | 10 Minutes |
| Average change in LVEF between prior clinical report and final report | Mean change in LVEF between prior clinical report and final report |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32269341 | Result | Ouyang D, He B, Ghorbani A, Yuan N, Ebinger J, Langlotz CP, Heidenreich PA, Harrington RA, Liang DH, Ashley EA, Zou JY. Video-based AI for beat-to-beat assessment of cardiac function. Nature. 2020 Apr;580(7802):252-256. doi: 10.1038/s41586-020-2145-8. Epub 2020 Mar 25. | |
| 37020027 | Derived | He B, Kwan AC, Cho JH, Yuan N, Pollick C, Shiota T, Ebinger J, Bello NA, Wei J, Josan K, Duffy G, Jujjavarapu M, Siegel R, Cheng S, Zou JY, Ouyang D. Blinded, randomized trial of sonographer versus AI cardiac function assessment. Nature. 2023 Apr;616(7957):520-524. doi: 10.1038/s41586-023-05947-3. Epub 2023 Apr 5. |
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| ID | Term |
|---|---|
| D054143 | Heart Failure, Systolic |
| D054144 | Heart Failure, Diastolic |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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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 EF calculation workflow will be used to calculate LVEF. The study team will assess how much cardiologists edit and change this preliminary interpretation is from the final interpretation.
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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.
| Sonographer Measurement of LVEF | Other | Standard practice sonographer measurement of left ventricle and assessment of LVEF |
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| 10 Minutes |