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Safety and Efficacy Study of AI LVEF (EchoNet-RCT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05140642
Recruitment Status : Completed
First Posted : December 1, 2021
Last Update Posted : July 5, 2022
Sponsor:
Information provided by (Responsible Party):
David Ouyang, Cedars-Sinai Medical Center

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.

Condition or disease Intervention/treatment Phase
Heart Failure, Systolic Heart Failure, Diastolic Other: Automated annotation of the left ventricle through deep learning Other: Sonographer Measurement of LVEF Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3495 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
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.
Masking: Single (Participant)
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.
Primary Purpose: Diagnostic
Official Title: Blinded Randomized Controlled Trial of Artificial Intelligence Guided Assessment of Cardiac Function
Actual Study Start Date : April 1, 2022
Actual Primary Completion Date : June 29, 2022
Actual Study Completion Date : June 29, 2022

Arm Intervention/treatment
Active Comparator: Sonographer Annotation
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.
Other: Sonographer Measurement of LVEF
Standard practice sonographer measurement of left ventricle and assessment of LVEF

Experimental: Artificial Intelligence Annotation
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.
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.




Primary Outcome Measures :
  1. Frequency of >5% change in LVEF between preliminary and final report [ Time Frame: 10 Minutes ]
    Proportion of studies the LVEF is changed more than 5% in final report

  2. Average change in LVEF between preliminary and final report [ Time Frame: 10 Minutes ]
    Mean change in LVEF between preliminary and final report


Secondary Outcome Measures :
  1. Frequency cardiologist adjusts preliminary annotation [ Time Frame: 10 Minutes ]
    Proportion of studies the annotation is changed

  2. Average change in LVEF between prior clinical report and final report [ Time Frame: 10 Minutes ]
    Mean change in LVEF between prior clinical report and final report



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 110 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05140642


Locations
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United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Sponsors and Collaborators
Cedars-Sinai Medical Center
Publications of Results:
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Responsible Party: David Ouyang, Staff Physician, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT05140642    
Other Study ID Numbers: STUDY00001707
First Posted: December 1, 2021    Key Record Dates
Last Update Posted: July 5, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by David Ouyang, Cedars-Sinai Medical Center:
Echocardiogram
Artificial Intelligence
Additional relevant MeSH terms:
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Heart Failure
Heart Failure, Systolic
Heart Failure, Diastolic
Heart Diseases
Cardiovascular Diseases