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

NCT05791227 | Not Yet Recruiting

• 1 other identifier: STUDY00002521
• Study Type: interventional
• Target: 4,000
• Locations: 0 countries
• Sites: N/A

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

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (6)

• Proportion of studies for which the difference in wall thickness between preliminary to overread is greater than 0.3cm for LVIDd

  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

  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

  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

  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

  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

  Measurement difference of LVPWd between preliminary to final assessment

  10 Minutes

Secondary Outcomes (3)

• mean absolute error (MAE) of wall thickness between cardiologist overread vs. historical clinical report wall thickness

  10 Minutes

• Time to complete each imaging study

  10 Minutes

• Effects of the AI systems integration with computer-human interaction (Blinding)

  10 Minutes

Study Arms (2)

Sonographer Annotation

ACTIVE COMPARATOR

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

Artificial Intelligence Annotation

EXPERIMENTAL

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

Interventions

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).

Sonographer Annotation

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).

Artificial Intelligence Annotation

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

David Ouyang

CONTACT

18324951605; david.ouyang@cshs.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Measurements shown in Picture Archiving and Communication System (PACS) without direct communication between sonographer and cardiologist. Annotations are shown without identifiers on how the annotations were done. Cardiologists are blinded to source of preliminary interpretation.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Physician

Model Details: 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 reporting workflow will be used visualize measurements of left ventricular diameter during diastole (LVIDd), intraventricular septum thickness during diastole (IVSd) and left ventricular posterior wall thickness during diastole (LVPWd). The study team will assess how much cardiologists edit and change this preliminary interpretation is from the final interpretation.

Study Record Dates

• First Submitted: March 3, 2023
• First Posted: March 30, 2023
• Study Start: April 1, 2025
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: February 20, 2025

Record last verified: 2025-02