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Heart Failure, SystolicEchoNet-RCTNCT05140642

Safety and Efficacy Study of AI LVEF

A study testing Automated annotation of the left ventricle through deep learning and Sonographer Measurement of LVEF in people with Heart Failure, Systolic and Heart Failure, Diastolic, run by Cedars-Sinai Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 110 years
What is being tested?
Automated annotation of the left ventricle through deep learning and Sonographer Measurement of LVEF
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,495 participants
Where
1 siteUnited States
Study dates
1 Apr 2022to 29 Jun 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 110 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • The study imaging studies will exclude transesophageal echocardiogram imaging.
  • The study will exclude cardiologists who decline to participate

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

Other trials in United States

About this study

Official title: Blinded Randomized Controlled Trial of Artificial Intelligence Guided Assessment of Cardiac Function

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.

Being tested
Automated annotation of the left ventricle through deep learning, Sonographer Measurement of LVEF
Keywords
Echocardiogram, Artificial Intelligence
Medical subject headings
Heart Failure, Systolic, Heart Failure, Diastolic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Automated annotation of the left ventricle through deep learningOther

    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 LVEFOther

    Standard practice sonographer measurement of left ventricle and assessment of LVEF

Study groups in NCT05140642
Study groupRoleWhat they receive
Sonographer AnnotationActive comparatorCurrently, 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.
Receives: Other: Sonographer Measurement of LVEF
Artificial Intelligence AnnotationExperimentalIn 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.
Receives: Other: Automated annotation of the left ventricle through deep learning

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Frequency of >5% change in LVEF between preliminary and final report

    Proportion of studies the LVEF is changed more than 5% in final report

    Measured: 10 Minutes

  2. Average change in LVEF between preliminary and final report

    Mean change in LVEF between preliminary and final report

    Measured: 10 Minutes

Secondary outcomes (2)

  1. Frequency cardiologist adjusts preliminary annotation

    Proportion of studies the annotation is changed

    Measured: 10 Minutes

  2. Average change in LVEF between prior clinical report and final report

    Mean change in LVEF between prior clinical report and final report

    Measured: 10 Minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Dec 2021
  2. Study start1 Apr 2022
  3. Primary completion29 Jun 2022
  4. Study completion29 Jun 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Single group
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 blind
Who is masked
Participant
Enrolment
3,495 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05140642
Sponsor's protocol ID
STUDY00001707
Acronym
EchoNet-RCT
Status last verified
Jun 2022
First submitted
17 Nov 2021
Last updated
5 Jul 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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. Epub 2020 Mar 25.

    PubMed 32269341

  • He B, Kwan AC, Cho JH, Yuan N, Pollick C, Shiota T, Ebinger J, Bello NA, Wei J, Josan K, Duffy G, Jujjavarapu M, Siegel R, Cheng S, Zou JY, Ouyang D. Blinded, randomized trial of sonographer versus AI cardiac function assessment. Nature. 2023 Apr;616(7957):520-524. doi: 10.1038/s41586-023-05947-3. Epub 2023 Apr 5.

    PubMed 37020027

Questions about this trial

What is this clinical trial studying?

A study testing Automated annotation of the left ventricle through deep learning and Sonographer Measurement of LVEF in people with Heart Failure, Systolic and Heart Failure, Diastolic, run by Cedars-Sinai Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frequency of >5% change in LVEF between preliminary and final report (time frame: 10 Minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05140642, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2022.

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