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Enrolling by invitation NCT05791227

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

No phase Interventional Heart Failure

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Sonographer Evaluation, AI Evaluation.
Who it may be relevant to
Registry conditions: Heart Failure. Basic parameters: 18 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • 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).
  • 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).

Primary outcome measures

  • 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 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 studies for which the difference in wall thickness between preliminary to overread is greater than 0.2cm for LVPWd [Time frame: 10 Minutes]
  • mean absolute error (MAE) of LVIDd between preliminary to overread between the two arms [Time frame: 10 Minutes]
  • mean absolute error (MAE) of IVSd between preliminary to overread between the two arms [Time frame: 10 Minutes]
  • mean absolute error (MAE) of LVPWd between preliminary to overread between the two arms [Time frame: 10 Minutes]
Secondary outcome measures (3)
  • mean absolute error (MAE) of wall thickness between cardiologist overread vs. historical clinical report wall thickness [Time frame: 10 Minutes]
  • Time to complete each imaging study [Time frame: 10 Minutes]
  • Effects of the AI systems integration with computer-human interaction (Blinding) [Time frame: 10 Minutes]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Diagnostic

Study locations

United States · 1 center
  • Cedars-Sinai Medical Center — Los Angeles

Identifiers

NCT: NCT05791227 · STUDY00002521

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗