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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03234257
Acronym
UF-Plaques
Enrollment
69
Registered
2017-07-31
Start date
2017-05-18
Completion date
2020-09-30
Last updated
2021-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carotid Stenosis

Keywords

Carotid stenosis, stiffness, ultrafast ultrasound imaging, Plaque stability

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: 1. to compare the stiffness between plaque and its adjacent arterial segments. 2. to show a correlation between the plaque's stiffness and the histological quantification of the fibrous tissue. 3. to demonstrate a correlation between the elasticity of the plaque and the histological quantification of the calcifications. 4. compare the quantification of vascularization by UF Doppler with the number of neovessels histologically quantified 5. To compare the quantification of the wall shear stress evaluated by UF Doppler between stable and unstable plaque. 6. to compare all the different parameters used to evaluated the plaque's stability, but depending on whether or not the carotid stenosis is symptomatic.

Interventions

DEVICEUF-ultrasound

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

Sponsors

INSERM U979 (Institut Langevin)
CollaboratorUNKNOWN
French Cardiology Society
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
local stiffness measurementthe day of enrollmentdemonstrate a significant difference in the local stiffness measurement using UF between the stable and unstable plaques, according to the histological criteria.

Secondary

MeasureTime frameDescription
correlation between the plaque's stiffness and the histological quantification of the fibrous tissue.at the end of the study (5 months)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 calcificationsThe quantification of the fibrous tissue is carried out in a semi-quantitative manner by a suitable scale, which will be filled in the histological analysisto 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
stiffness between plaque and its adjacent arterial segmentsThe day of enrollment.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.
the quantification of the wall shear stress evaluated by UF Doppler between stable and unstable plaque.the day of enrollmentTo 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 symptomaticthe day of enrollmentto compare all the different parameters used to evaluated the plaque's stability, but depending on whether or not the carotid stenosis is symptomatic
the quantification of vascularization by UF Doppler with the number of neovessels histologically quantifiedthe day of enrollmentcompare 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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 22, 2026