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OpenTrials
Completed

NCT Number: NCT05140642

Safety and Efficacy Study of AI LVEF

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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Key information

Conditions

Heart Failure, Systolic Cardiovascular Diseases Heart Diseases Heart Failure Heart Failure, Diastolic

Age range

18 year–110 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Sonographer Measurement of LVEF

Other

Standard practice sonographer measurement of left ventricle and assessment of LVEF

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Cedars-Sinai Medical Center

Other

Registry information

Official study title

Blinded Randomized Controlled Trial of Artificial Intelligence Guided Assessment of Cardiac Function

Acronym: EchoNet-RCT

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Dec 1, 2021
Registry last updated
Jul 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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