Carotid StenosisUF-PlaquesNCT03234257
Evaluation of the Carotid Plaque Stability by Ultrafast-ultrasound Imaging (UF)
A study testing UF-ultrasound in people with Carotid Stenosis, run by French Cardiology Society at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carotid Stenosis
- What is being tested?
- UF-ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteFrance
- Study dates
- 18 May 2017to 30 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Non-atherosclerotic carotid stenosis (post-radiation stenosis)
- No social security coverage
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Carotid Stenosis
- Being tested
- UF-ultrasound
- Keywords
- Carotid stenosis, stiffness, ultrafast ultrasound imaging, Plaque stability
- Medical subject headings
- Carotid Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UF-ultrasoundDevice
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
| Study group | Role | What they receive |
|---|---|---|
| patients with carotid stenosis. | Other | asymptomatic patients with carotid stenosis. Receives: Device: UF-ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: the day of enrollment
Secondary outcomes (6)
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.
Measured: The day of enrollment.
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.
Measured: at the end of the study (5 months)
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
Measured: 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
Measured: the day of enrollment
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.
Measured: the day of enrollment
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
Measured: the day of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2017
- Study start18 May 2017
- Primary completion5 May 2019
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Carotid StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- French Cardiology Society
- Sponsor type
- University, hospital or other
- Collaborators
- INSERM U979 (Institut Langevin)
- Responsible party
- Sponsor
- Investigators
- Emmanuel MESSAS, Principal investigator, emmanuel.messas@aphp.fr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03234257
- Sponsor's protocol ID
- 2016-03
- Acronym
- UF-Plaques
- Status last verified
- Aug 2021
- First submitted
- 10 Jul 2017
- Last updated
- 9 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34181190
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Carotid Plaque Stability by Ultrafast-ultrasound Imaging (UF)
- ClinicalTrials.gov ID
- NCT03234257
- Acronym / sponsor ID
- UF-Plaques / 2016-03
- Conditions
- Carotid Stenosis
- Keywords
- Carotid stenosis, stiffness, ultrafast ultrasound imaging, Plaque stability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- French Cardiology SocietyUniversity, hospital or other
- Collaborators
- INSERM U979 (Institut Langevin)
- Study start
- 18 May 2017 (actual)
- Primary completion
- 5 May 2019 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 31 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with carotid stenosis. | Other | Device: UF-ultrasoundasymptomatic patients with carotid stenosis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Non-atherosclerotic carotid stenosis (post-radiation stenosis)
- No social security coverage
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UF-ultrasoundthe 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 | Device | patients with carotid stenosis. |
Primary outcome
local stiffness measurement
Time frame: the day of enrollment
demonstrate a significant difference in the local stiffness measurement using UF between the stable and unstable plaques, according to the histological criteria.
6 secondary outcomes
stiffness between plaque and its adjacent arterial segments
Time frame: The day of enrollment.
correlation between the plaque's stiffness and the histological quantification of the fibrous tissue.
Time frame: at the end of the study (5 months)
correlation between the elasticity of the plaque and the histological quantification of the calcifications
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
the quantification of vascularization by UF Doppler with the number of neovessels histologically quantified
Time frame: the day of enrollment
the quantification of the wall shear stress evaluated by UF Doppler between stable and unstable plaque.
Time frame: the day of enrollment
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2021.
- Derived from this study: PubMed 34181190Goudot 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emmanuel MESSAS principal investigator
emmanuel.messas@aphp.fr
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing UF-ultrasound in people with Carotid Stenosis, run by French Cardiology Society at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
local stiffness measurement (time frame: the day of enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03234257, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2021.