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Deep Learning

Automated annotation of the left ventricle through deep learning for Heart Failure (EchoNet-RCT Trial)

N/A
Waitlist Available
Research Sponsored by Cedars-Sinai Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 minutes
Awards & highlights

EchoNet-RCT 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.

Eligible Conditions
  • Heart Failure

EchoNet-RCT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 minutes
This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 minutes for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Average change in LVEF between preliminary and final report
Frequency of >5% change in LVEF between preliminary and final report
Secondary outcome measures
Average change in LVEF between prior clinical report and final report
Frequency cardiologist adjusts preliminary annotation

EchoNet-RCT Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Artificial Intelligence AnnotationExperimental Treatment1 Intervention
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.
Group II: Sonographer AnnotationActive Control1 Intervention
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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Who is running the clinical trial?

Cedars-Sinai Medical CenterLead Sponsor
500 Previous Clinical Trials
161,368 Total Patients Enrolled
11 Trials studying Heart Failure
6,559 Patients Enrolled for Heart Failure

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Safety and Efficacy Study of AI LVEF
David Ouyang 2022. "Safety and Efficacy Study of AI LVEF". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05140642.
~1165 spots leftby Apr 2025
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