Concordance AUTOFEVG
CONCORDANCEVEF
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)
2 other identifiers
interventional
60
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 13, 2020
CompletedFirst Posted
Study publicly available on registry
November 23, 2020
CompletedStudy Start
First participant enrolled
June 8, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 8, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 8, 2022
CompletedDecember 4, 2025
March 1, 2024
1.1 years
July 13, 2020
November 27, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
evaluate the interobserver reproducibility
evaluate the interobserver reproducibility of the automatic measurement of LVEF with a pocket ultrasound device
Day 0
Secondary Outcomes (5)
Assess the interobserver reproducibility of visual LVEF
day 0
Interobserver reproducibility of the visual LVEF measurement;
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.
Day 0
Ability of the pocket ultrasound scanner to give an ultrasound image useable by the doctor performing the examination considering image quality
Day 0
Study Arms (1)
Echocardiography
OTHER• 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
Interventions
Four measurements in echocardiography performed in addition to standard care
Eligibility Criteria
You may qualify if:
- Patient over 18 years of age
- Management in the investigator centre
- Admitted for dyspnea or hypotension or chest pain
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHRU de Nîmes - Hôpital Universitaire Carémeau
Nîmes, 30029, France
Related Publications (1)
Berger L, Coisy F, Sammoud S, de Oliveira F, Grandpierre RG, Grau-Mercier L, Bobbia X, Markarian T. Evaluation of left ventricular ejection fraction by a new automatic tool on a pocket ultrasound device: Concordance study with cardiac magnetic resonance imaging. PLoS One. 2024 Aug 12;19(8):e0308580. doi: 10.1371/journal.pone.0308580. eCollection 2024.
PMID: 39133705RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xavier Bobbia, MD
Centre Hospitalier Universitaire de Nîmes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 13, 2020
First Posted
November 23, 2020
Study Start
June 8, 2021
Primary Completion
July 8, 2022
Study Completion
July 8, 2022
Last Updated
December 4, 2025
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will not share