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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Cedars-Sinai Medical Center
Study ID
NCT05791227
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

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).
  • 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).

Study Details

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.

Key Dates

First listed
Mar 30, 2023
Start date
Apr 1, 2025
Status verified
Jul 2026
Primary completion
Nov 1, 2026
Completion
Jan 1, 2027

Study Design

Enrollment
4,000 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • 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.
  • 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.

Primary Outcome Measure

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 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Cedars-Sinai Medical CenterLos AngelesCalifornia90048-

Find similar trials in Los Angeles, CA

By condition
Heart failure
By specialty
CardiologyHeart disease
By research site
Cedars-Sinai Medical Center· Los Angeles, CA

Related Studies