Concordance AUTOFEVG (CONCORDANCEVEF)
November 27, 2025 updated by: Centre Hospitalier Universitaire de Nīmes
Evaluation of the Ejection Fraction of the Left Ventricle Ejection Fraction (LVEF) by a New Automatic Evaluation Tool in a Pocket Ultrasound Device: Study of Concordance With the Estimated by Cardiac Magnetic Reasoning Imaging (MRI)
Clinical ultrasound has become essential in emergency medicine.
The guidelines are to use of echocardiography in specific contexts: dyspnea, hypotension or chest pain.
The evaluation of left ventricle ejection fraction (LVEF) is one of the basic objectives of echocardiography.
The reference assessment in emergency medicine is visual assessment.
It suffers from poor inter-observer reproducibility.
Pocket ultrasound scanners seem to meet the constraints of point-of-care ultrasound.
A new tool is available on a pocket ultrasound device: the automatic evaluation of LVEF.
Its interest could be to have a better inter-observer reproducibility than visual evaluation.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Nîmes, France, 30029
- CHRU de Nîmes - Hôpital Universitaire Carémeau
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion criteria:
- Patient over 18 years of age
- Management in the investigator centre
- Admitted for dyspnea or hypotension or chest pain
Exclusion criteria:
- Age < 18 years
- Patient not benefiting from a social security system
- Patient deprived of liberty
- Patient under the protection of justice, under guardianship or curatorship
- Patient refusing to participate in the study
- Inability to provide the patient with informed information
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Echocardiography
• Echocardiography performed by the evaluator 1: 2 LVEF visual evaluations 2 LVEF automatic evaluations • Echocardiography performed by the evaluator 2: 2 LVEF visual evaluations 2 LVEF automatic evaluations |
Four measurements in echocardiography performed in addition to standard care
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
evaluate the interobserver reproducibility
Time Frame: Day 0
|
evaluate the interobserver reproducibility of the automatic measurement of LVEF with a pocket ultrasound device
|
Day 0
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assess the interobserver reproducibility of visual LVEF
Time Frame: day 0
|
Assess the interobserver reproducibility of visual LVEF
|
day 0
|
|
Interobserver reproducibility of the visual LVEF measurement;
Time Frame: Day 0
|
Assess the interobserver reproducibility of the visual LVEF measurement;
|
Day 0
|
|
Evaluate the intraobserver reproducibility of the automatic LVEF measurement
Time Frame: Day 0
|
Evaluate the intraobserver reproducibility of the automatic LVEF measurement
|
Day 0
|
|
Ability of the pocket ultrasound scanner to give an ultrasound image useable by the doctor performing the examination.
Time Frame: Day 0
|
feasibility of each method (visual and automatic) to obtain an ultrasound image useable
|
Day 0
|
|
Ability of the pocket ultrasound scanner to give an ultrasound image useable by the doctor performing the examination considering image quality
Time Frame: Day 0
|
Quality of image obtained by each méthod (Visual and Automatic)
|
Day 0
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Xavier Bobbia, MD, Centre Hospitalier Universitaire de Nîmes
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 8, 2021
Primary Completion (Actual)
July 8, 2022
Study Completion (Actual)
July 8, 2022
Study Registration Dates
First Submitted
July 13, 2020
First Submitted That Met QC Criteria
November 20, 2020
First Posted (Actual)
November 23, 2020
Study Record Updates
Last Update Posted (Estimated)
December 4, 2025
Last Update Submitted That Met QC Criteria
November 27, 2025
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LOCAL/2020/XB-01
- 2020-A01422-37 (Other Identifier: ANSM)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.