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Evaluation of the Carotid Plaque Stability by Ultrafast-ultrasound Imaging (UF) (UF-Plaques)

Primary Purpose

Carotid Stenosis

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
UF-ultrasound
Sponsored by
French Cardiology Society
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Carotid Stenosis focused on measuring Carotid stenosis, stiffness, ultrafast ultrasound imaging, Plaque stability

Eligibility Criteria

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

Inclusion Criteria:

  • Adults over 18 years, referred to H.E.G.P for carotid endarterectomy,
  • beneficiaries of a social security scheme,
  • having received research information and signed the consent form.

Exclusion Criteria:

  • Non-atherosclerotic carotid stenosis (post-radiation stenosis)
  • No social security coverage

Sites / Locations

  • Hopital Europeen Georges Pompidou

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

patients with carotid stenosis.

Arm Description

asymptomatic patients with carotid stenosis.

Outcomes

Primary Outcome Measures

local stiffness measurement
demonstrate a significant difference in the local stiffness measurement using UF between the stable and unstable plaques, according to the histological criteria.

Secondary Outcome Measures

stiffness between plaque and its adjacent arterial segments
compare the stiffness between plaque and its adjacent arterial segmentsThe local arterial stiffness (for plaque and its adjacent segments) is evaluated by shear wave imaging (SWE) with the Aixplorer® (SuperSonic© Imaging). Dedicated SWE sequences provide a mapping of local stiffness. The value of the stiffness retained is the average of the region fixed by contouring the plate and the adjacent segments on the B-mode image.
correlation between the plaque's stiffness and the histological quantification of the fibrous tissue.
show a correlation between the plaque's stiffness and the histological quantification of the fibrous tissue.
correlation between the elasticity of the plaque and the histological quantification of the calcifications
to demonstrate a correlation between the elasticity of the plaque and the histological quantification of the calcifications.The quantification of the fibrous tissue is carried out in a semi-quantitative manner by a suitable scale, which will be filled in the histological analysis
the quantification of vascularization by UF Doppler with the number of neovessels histologically quantified
compare the quantification of vascularization by UF Doppler with the number of neovessels histologically quantified. The quantification of the calcifications is carried out in a semi-quantitative manner by a suitable scale, which will be filled in the histological analysis
the quantification of the wall shear stress evaluated by UF Doppler between stable and unstable plaque.
To compare the quantification of the wall shear stress evaluated by UF Doppler between stable and unstable plaque.The quantification of wall shear stress is done using the UF Doppler mode. This is the measure of the average speed of the carotid flow, in contact with the plaque.
compare all the different parameters used to evaluated the plaque's stability, but depending on whether or not the carotid stenosis is symptomatic
to compare all the different parameters used to evaluated the plaque's stability, but depending on whether or not the carotid stenosis is symptomatic

Full Information

First Posted
July 10, 2017
Last Updated
August 6, 2021
Sponsor
French Cardiology Society
Collaborators
INSERM U979 (Institut Langevin)
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1. Study Identification

Unique Protocol Identification Number
NCT03234257
Brief Title
Evaluation of the Carotid Plaque Stability by Ultrafast-ultrasound Imaging (UF)
Acronym
UF-Plaques
Official Title
Evaluation of the Carotid Plaque Stability by Ultrafast-ultrasound Imaging (UF)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
May 18, 2017 (Actual)
Primary Completion Date
May 5, 2019 (Actual)
Study Completion Date
September 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
French Cardiology Society
Collaborators
INSERM U979 (Institut Langevin)

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
Unstable plaques are characterized by lower segmental stiffness and intimal neovascularization compared to stable plaques. Our objective is to determine the capacity of the elastographic parameters obtained by the UF to discriminate the unstable to the stable plaques. We hope to improve the stroke prediction in asymptomatic patients with carotid stenosis.
Detailed Description
Context Stroke is the second leading cause of death in the Western world and the leading cause of major disability in the long term. About 15% of strokes are secondary to thrombosis or embolization of an unstable atherosclerotic plaque of the carotid bifurcation. In these symptomatic patients, the degree of carotid stenosis is correlated with the risk of early recurrence. In patients with stenosis (NASCET)> 70%, endarterectomy is an intervention aimed at removing the carotid plaque to prevent stroke. In asymptomatic patients, the degree of stenosis is a limited predictive factor and a better risk stratification is required to assess the degree of the plaque vulnerability. The therapeutic decision towards endarterectomy in addition to drug therapy is debated because of a variable benefit/ risk balance. Several imaging parameters were studied: anfractuosity, heterogeneity, and vascularization of the plaque for example, without allowing a modification of the current recommendations. Our objective is to improve the evaluation of the risk of stroke by the fine characterization of the carotid stenosis to help the medical decision. We want to evaluate a new ultrasound imaging technology called Ultrafast ultrasound imaging (UF). Ultrasound has the advantage of being a non-irradiating, low-cost easily accessible. Hypotheses Unstable plaques are characterized by lower segmental stiffness and intimal neovascularization compared to stable plaques. Our objective is to determine the capacity of the elastographic parameters obtained by the UF to discriminate the unstable to the stable plaques. We hope to improve the stroke prediction in asymptomatic patients with carotid stenosis. Innovative aspects The originality of the approach is the use of an advanced imaging technique, UF, developed by the Langevin Institute with Mathias Fink, and already validated in the study of arterial stiffness with pulse wave analysis . This project for the application of UF in atherosclerotic plaques stems from the ability to analyze the biomechanical properties of tissues by ultrasound elastography, already developed in the breast, liver and thyroid. Not only does UF determine the tissue stiffness expressed in kPa (Young's modulus) of the arterial wall and therefore of the carotid plaque, but UF also offers the possibility of establishing a rigidity mapping at the μm3 scale And therefore to approach the variability of the rigidity inside the plaque. Moreover, following the recent development of the Doppler UF by the Langevin Institute, the capabilities of this tool in the precise detection of microvascular flows make it a cutting-edge tool adapted to the study of the vascularization of the carotid plaque As well as the study of the hemodynamic shear stresses that apply to the surface of the plaque. Objective Our objective is the development and validation of informative biomarkers of the carotid plaque stability by UF in order to improve the stroke prediction in case of asymptomatic stenosis. A UF-ultrasound approach is a non-irradiating, easily accessible, and low cost technique. The primary objective of this study is: - to demonstrate a significant difference in the local stiffness measurement using UF between the stable and unstable plaques, according to the histological criteria. The secondary objectives are: to compare the stiffness between plaque and its adjacent arterial segments. to show a correlation between the plaque's stiffness and the histological quantification of the fibrous tissue. to demonstrate a correlation between the elasticity of the plaque and the histological quantification of the calcifications. compare the quantification of vascularization by UF Doppler with the number of neovessels histologically quantified To compare the quantification of the wall shear stress evaluated by UF Doppler between stable and unstable plaque. to compare all the different parameters used to evaluated the plaque's stability, but depending on whether or not the carotid stenosis is symptomatic.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carotid Stenosis
Keywords
Carotid stenosis, stiffness, ultrafast ultrasound imaging, Plaque stability

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
69 (Actual)

8. Arms, Groups, and Interventions

Arm Title
patients with carotid stenosis.
Arm Type
Other
Arm Description
asymptomatic patients with carotid stenosis.
Intervention Type
Device
Intervention Name(s)
UF-ultrasound
Intervention Description
the carotid plaque stability by UF in order to improve the stroke prediction in case of asymptomatic stenosis. A UF-ultrasound approach is a non-irradiating, easily accessible, and low cost technique
Primary Outcome Measure Information:
Title
local stiffness measurement
Description
demonstrate a significant difference in the local stiffness measurement using UF between the stable and unstable plaques, according to the histological criteria.
Time Frame
the day of enrollment
Secondary Outcome Measure Information:
Title
stiffness between plaque and its adjacent arterial segments
Description
compare the stiffness between plaque and its adjacent arterial segmentsThe local arterial stiffness (for plaque and its adjacent segments) is evaluated by shear wave imaging (SWE) with the Aixplorer® (SuperSonic© Imaging). Dedicated SWE sequences provide a mapping of local stiffness. The value of the stiffness retained is the average of the region fixed by contouring the plate and the adjacent segments on the B-mode image.
Time Frame
The day of enrollment.
Title
correlation between the plaque's stiffness and the histological quantification of the fibrous tissue.
Description
show a correlation between the plaque's stiffness and the histological quantification of the fibrous tissue.
Time Frame
at the end of the study (5 months)
Title
correlation between the elasticity of the plaque and the histological quantification of the calcifications
Description
to demonstrate a correlation between the elasticity of the plaque and the histological quantification of the calcifications.The quantification of the fibrous tissue is carried out in a semi-quantitative manner by a suitable scale, which will be filled in the histological analysis
Time Frame
The quantification of the fibrous tissue is carried out in a semi-quantitative manner by a suitable scale, which will be filled in the histological analysis
Title
the quantification of vascularization by UF Doppler with the number of neovessels histologically quantified
Description
compare the quantification of vascularization by UF Doppler with the number of neovessels histologically quantified. The quantification of the calcifications is carried out in a semi-quantitative manner by a suitable scale, which will be filled in the histological analysis
Time Frame
the day of enrollment
Title
the quantification of the wall shear stress evaluated by UF Doppler between stable and unstable plaque.
Description
To compare the quantification of the wall shear stress evaluated by UF Doppler between stable and unstable plaque.The quantification of wall shear stress is done using the UF Doppler mode. This is the measure of the average speed of the carotid flow, in contact with the plaque.
Time Frame
the day of enrollment
Title
compare all the different parameters used to evaluated the plaque's stability, but depending on whether or not the carotid stenosis is symptomatic
Description
to compare all the different parameters used to evaluated the plaque's stability, but depending on whether or not the carotid stenosis is symptomatic
Time Frame
the day of enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adults over 18 years, referred to H.E.G.P for carotid endarterectomy, beneficiaries of a social security scheme, having received research information and signed the consent form. Exclusion Criteria: Non-atherosclerotic carotid stenosis (post-radiation stenosis) No social security coverage
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emmanuel MESSAS
Organizational Affiliation
emmanuel.messas@aphp.fr
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital Europeen Georges Pompidou
City
Paris
ZIP/Postal Code
75015
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
34181190
Citation
Goudot G, Sitruk J, Jimenez A, Julia P, Khider L, Alsac JM, El Batti S, Bruneval P, Amemyia K, Pedreira O, Mortelette H, Calvet D, Tanter M, Mirault T, Pernot M, Messas E. Carotid Plaque Vulnerability Assessed by Combined Shear Wave Elastography and Ultrafast Doppler Compared to Histology. Transl Stroke Res. 2022 Feb;13(1):100-111. doi: 10.1007/s12975-021-00920-6. Epub 2021 Jun 28.
Results Reference
derived

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Evaluation of the Carotid Plaque Stability by Ultrafast-ultrasound Imaging (UF)

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