Safety and Efficacy Study of AI Wall Thickness Measurement (EchoNet-LVH-RCT)

February 8, 2024 updated by: David Ouyang, Cedars-Sinai Medical Center

EchoNet-LVH-RCT: Blinded, Randomized Controlled Trial of Artificial Intelligence Guided Precision Assessment of Wall Thickness

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 wall thickness in parasternal long axis view compared to sonographer measurements in preliminary readings of echocardiograms.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

4000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Sonographers and cardiologists at CSMC Echocardiography Lab
  • All transthoracic echocardiogram studies performed in the CSMC echocardiogram lab

Exclusion Criteria:

  • transthoracic echocardiogram studies not able to be measured by sonographers in run in period

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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.
Diagnostic test: Sonographer Evaluation
A sonographer will assess measurements of left ventricular diameter during diastole (LVIDd), intraventricular septum thickness during diastole (IVSd) and left ventricular posterior wall thickness during diastole (LVPWd).
Experimental: Artificial Intelligence Annotation
A novel AI algorithm developed to assess measurements of left ventricular diameter during diastole (LVIDd), intraventricular septum thickness during diastole (IVSd) and left ventricular posterior wall thickness during diastole (LVPWd). The AI will provide preliminary assessments for cardiologist evaluation.
Diagnostic test: AI Evaluation
An AI model will assess measurements of left ventricular diameter during diastole (LVIDd), intraventricular septum thickness during diastole (IVSd) and left ventricular posterior wall thickness during diastole (LVPWd).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of studies for which the difference in wall thickness between preliminary to overread is greater than 0.3cm for LVIDd
Time Frame: 10 Minutes
Proportion of significant difference in LVIDd between preliminary to final assessment
10 Minutes
Proportion of studies for which the difference in wall thickness between preliminary to overread is greater than 0.2cm for IVSd
Time Frame: 10 Minutes
Proportion of significant difference in IVSd between preliminary to final assessment
10 Minutes
Proportion of studies for which the difference in wall thickness between preliminary to overread is greater than 0.2cm for LVPWd
Time Frame: 10 Minutes
Proportion of significant difference in LVPWd between preliminary to final assessment
10 Minutes
mean absolute error (MAE) of LVIDd between preliminary to overread between the two arms
Time Frame: 10 Minutes
Measurement difference of LVIDd between preliminary to final assessment
10 Minutes
mean absolute error (MAE) of IVSd between preliminary to overread between the two arms
Time Frame: 10 Minutes
Measurement difference of IVSd between preliminary to final assessment
10 Minutes
mean absolute error (MAE) of LVPWd between preliminary to overread between the two arms
Time Frame: 10 Minutes
Measurement difference of LVPWd between preliminary to final assessment
10 Minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mean absolute error (MAE) of wall thickness between cardiologist overread vs. historical clinical report wall thickness
Time Frame: 10 Minutes
Mean absolute error (MAE) of wall thickness between cardiologist overread with initial interpretation vs. prior clinical report wall thickness
10 Minutes
Time to complete each imaging study
Time Frame: 10 Minutes
Time for sonographers and cardiologists to complete a study (in seconds)
10 Minutes
Effects of the AI systems integration with computer-human interaction (Blinding)
Time Frame: 10 Minutes
Whether cardiologists can tell the difference between human vs. AI initial interpretation (Bang's blinding index, or the proportion of studies guessed correctly to be AI or sonographer compared to ground truth of whether it was AI or sonographer).
10 Minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cedars-Sinai Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2024

Primary Completion (Estimated)

November 1, 2024

Study Completion (Estimated)

November 1, 2024

Study Registration Dates

First Submitted

March 3, 2023

First Submitted That Met QC Criteria

March 28, 2023

First Posted (Actual)

March 30, 2023

Study Record Updates

Last Update Posted (Actual)

February 12, 2024

Last Update Submitted That Met QC Criteria

February 8, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00002521

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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