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Concordance AUTOFEVG (CONCORDANCEVEF)

Primary Purpose

Echocardiography, Medicine, Emergency, Technology Assessment, Biomedical

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
echocardiography
Sponsored by
Centre Hospitalier Universitaire de Nīmes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Echocardiography

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHRU de Nîmes - Hôpital Universitaire CarémeauRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Echocardiography

Arm Description

• 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

Outcomes

Primary Outcome Measures

evaluate the interobserver reproducibility
evaluate the interobserver reproducibility of the automatic measurement of LVEF with a pocket ultrasound device

Secondary Outcome Measures

Assess the interobserver reproducibility of visual LVEF
Assess the interobserver reproducibility of visual LVEF
Interobserver reproducibility of the visual LVEF measurement;
Assess the interobserver reproducibility of the visual LVEF measurement;
Evaluate the intraobserver reproducibility of the automatic LVEF measurement
Evaluate the intraobserver reproducibility of the automatic LVEF measurement
Ability of the pocket ultrasound scanner to give an ultrasound image useable by the doctor performing the examination.
feasibility of each method (visual and automatic) to obtain an ultrasound image useable
Ability of the pocket ultrasound scanner to give an ultrasound image useable by the doctor performing the examination considering image quality
Quality of image obtained by each méthod (Visual and Automatic)

Full Information

First Posted
July 13, 2020
Last Updated
June 15, 2021
Sponsor
Centre Hospitalier Universitaire de Nīmes
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1. Study Identification

Unique Protocol Identification Number
NCT04641169
Brief Title
Concordance AUTOFEVG
Acronym
CONCORDANCEVEF
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 8, 2021 (Actual)
Primary Completion Date
January 1, 2022 (Anticipated)
Study Completion Date
January 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nīmes

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Echocardiography, Medicine, Emergency, Technology Assessment, Biomedical, Heart Diseases

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Echocardiography
Arm Type
Other
Arm Description
• 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
Intervention Type
Procedure
Intervention Name(s)
echocardiography
Intervention Description
Four measurements in echocardiography performed in addition to standard care
Primary Outcome Measure Information:
Title
evaluate the interobserver reproducibility
Description
evaluate the interobserver reproducibility of the automatic measurement of LVEF with a pocket ultrasound device
Time Frame
Day 0
Secondary Outcome Measure Information:
Title
Assess the interobserver reproducibility of visual LVEF
Description
Assess the interobserver reproducibility of visual LVEF
Time Frame
day 0
Title
Interobserver reproducibility of the visual LVEF measurement;
Description
Assess the interobserver reproducibility of the visual LVEF measurement;
Time Frame
Day 0
Title
Evaluate the intraobserver reproducibility of the automatic LVEF measurement
Description
Evaluate the intraobserver reproducibility of the automatic LVEF measurement
Time Frame
Day 0
Title
Ability of the pocket ultrasound scanner to give an ultrasound image useable by the doctor performing the examination.
Description
feasibility of each method (visual and automatic) to obtain an ultrasound image useable
Time Frame
Day 0
Title
Ability of the pocket ultrasound scanner to give an ultrasound image useable by the doctor performing the examination considering image quality
Description
Quality of image obtained by each méthod (Visual and Automatic)
Time Frame
Day 0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xavier Bobbia, MD
Phone
+33.(0)4.66.68.30.50
Email
xavier.bobbia@chu-nimes.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xavier Bobbia, MD
Organizational Affiliation
Centre Hospitalier Universitaire de Nîmes
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHRU de Nîmes - Hôpital Universitaire Carémeau
City
Nîmes Cedex 9
ZIP/Postal Code
30029
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xavier Bobbia, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Concordance AUTOFEVG

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