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

Cedars-Sinai Medical Center

Status: Not yet enrolling

Conditions: Heart Failure

Treatments: Diagnostic Test: AI Evaluation; Diagnostic Test: Sonographer Evaluation

Study type: Interventional

Funder types: Other

Identifiers

NCT05791227

STUDY00002521

Details and patient eligibility

About

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.

Enrollment: 4,000 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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4,000 participants in 2 patient groups

Sonographer Annotation

Active Comparator group

Description:

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.

Treatment:

Diagnostic Test: Sonographer Evaluation

Artificial Intelligence Annotation

Experimental group

Description:

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.

Treatment:

Diagnostic Test: AI Evaluation