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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05140642
Other study ID # STUDY00001707
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 1, 2022
Est. completion date June 29, 2022

Study information

Verified date June 2022
Source Cedars-Sinai Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 3495
Est. completion date June 29, 2022
Est. primary completion date June 29, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 110 Years
Eligibility 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

Study Design


Intervention

Other:
Automated 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.
Sonographer Measurement of LVEF
Standard practice sonographer measurement of left ventricle and assessment of LVEF

Locations

Country Name City State
United States Cedars-Sinai Medical Center Los Angeles California

Sponsors (1)

Lead Sponsor Collaborator
Cedars-Sinai Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. Epu — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary Average change in LVEF between preliminary and final report Mean change in LVEF between preliminary and final report 10 Minutes
Secondary Frequency cardiologist adjusts preliminary annotation Proportion of studies the annotation is changed 10 Minutes
Secondary Average change in LVEF between prior clinical report and final report Mean change in LVEF between prior clinical report and final report 10 Minutes
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