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Enrolling by Invitation

NCT Number: NCT05791227

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

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year–100 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

  • 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

Treatment and study plan

Sonographer Evaluation

Diagnostic Test

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).

AI Evaluation

Diagnostic Test

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 outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

Secondary outcomes

  1. 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

  2. Time to complete each imaging study

    Time frame: 10 Minutes

    Time for sonographers and cardiologists to complete a study (in seconds)

  3. 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).

Sponsors and collaborators

Lead sponsor

Cedars-Sinai Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Mar 30, 2023
Registry last updated
Jul 22, 2026

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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