Safety and Efficacy Study of AI LVEF

Not Applicable

Completed

• Conditions: Heart Failure, Systolic; Heart Failure, Diastolic

• Registration Number: NCT05140642
• Lead Sponsor: Cedars-Sinai Medical Center

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 left ventricular ejection fraction compared to sonographer measurements in preliminary readings of echocardiograms.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-17
• Study First Submitted QC: 2021-11-30
• Study First Posted: 2021-12-01
• Study Start: 2022-04-01
• Status Verified: 2022-06
• Primary Completion: 2022-06-29
• Study Completion: 2022-06-29
• Last Update Submitted: 2022-06-30
• Last Update Posted: 2022-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3495

Inclusion Criteria

• The study imaging studies will include patients who underwent imaging (limited or comprehensive transthoracic echocardiogram studies) and a LVEF was adjudicated in the echocardiography/non-invasive cardiac imaging laboratory.
• The study participants are cardiologists reading in the echocardiography/non-invasive cardiac imaging laboratory.

Exclusion Criteria

• The study imaging studies will exclude transesophageal echocardiogram imaging.
• The study will exclude cardiologists who decline to participate

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Average change in LVEF between preliminary and final report	10 Minutes	Mean change in LVEF between preliminary and final report
Frequency of >5% change in LVEF between preliminary and final report	10 Minutes	Proportion of studies the LVEF is changed more than 5% in final report

Secondary Outcome Measures

Name	Time	Method
Frequency cardiologist adjusts preliminary annotation	10 Minutes	Proportion of studies the annotation is changed
Average change in LVEF between prior clinical report and final report	10 Minutes	Mean change in LVEF between prior clinical report and final report

Trial Locations

Locations (1)

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States