Heart Failure, Diastolic, Heart Failure, Systolic
Conditions
Keywords
Echocardiogram, Artificial Intelligence
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 left ventricular ejection fraction compared to sonographer measurements in preliminary readings of echocardiograms.
Interventions
OTHERAutomated annotation of the left ventricle through deep learning
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.
OTHERSonographer Measurement of LVEF
Standard practice sonographer measurement of left ventricle and assessment of LVEF
Sponsors
Cedars-Sinai Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
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 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 110 Years
Healthy volunteers
No
Inclusion criteria
* The study imaging studies will include patients who underwent imaging (limited or comprehensive transthoracic echocardiogram studies) and a LVEF was adjudicated in the echocardiography/non-invasive cardiac imaging laboratory. * The study participants are cardiologists reading in the echocardiography/non-invasive cardiac imaging laboratory.
Exclusion criteria
* The study imaging studies will exclude transesophageal echocardiogram imaging. * The study will exclude cardiologists who decline to participate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of >5% change in LVEF between preliminary and final report | 10 Minutes | Proportion of studies the LVEF is changed more than 5% in final report |
| Average change in LVEF between preliminary and final report | 10 Minutes | Mean change in LVEF between preliminary and final report |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency cardiologist adjusts preliminary annotation | 10 Minutes | Proportion of studies the annotation is changed |
| Average change in LVEF between prior clinical report and final report | 10 Minutes | Mean change in LVEF between prior clinical report and final report |
Countries
United States
Outcome results
None listed