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Trial record 9 of 48 for:    Recruiting, Not yet recruiting, Available Studies | "Carotid Stenosis"

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

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ClinicalTrials.gov Identifier: NCT03234257
Recruitment Status : Recruiting
First Posted : July 31, 2017
Last Update Posted : February 19, 2019
Sponsor:
Collaborator:
INSERM U979 (Institut Langevin)
Information provided by (Responsible Party):
French Cardiology Society

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.

Condition or disease Intervention/treatment Phase
Carotid Stenosis Device: UF-ultrasound Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 55 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of the Carotid Plaque Stability by Ultrafast-ultrasound Imaging (UF)
Actual Study Start Date : May 21, 2018
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
patients with carotid stenosis.
asymptomatic patients with carotid stenosis.
Device: UF-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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. stiffness between plaque and its adjacent arterial segments [ Time Frame: The 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.

  2. correlation between the plaque's stiffness and the histological quantification of the fibrous tissue. [ Time Frame: at the end of the study (5 months) ]
    show a correlation between the plaque's stiffness and the histological quantification of the fibrous tissue.

  3. 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 ]
    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

  4. the quantification of vascularization by UF Doppler with the number of neovessels histologically quantified [ Time Frame: the day of enrollment ]
    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

  5. the quantification of the wall shear stress evaluated by UF Doppler between stable and unstable plaque. [ Time Frame: the day of enrollment ]
    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.

  6. 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 ]
    to compare all the different parameters used to evaluated the plaque's stability, but depending on whether or not the carotid stenosis is symptomatic



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03234257


Contacts
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Contact: Tessa BERGOT +33144907033 tessa.bergot@sfcardio.fr

Locations
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France
Hopital Europeen Georges Pompidou Recruiting
Paris, France, 75015
Contact: Emmanuel MESSAS         
Principal Investigator: Emmanuel MESSAS         
Sponsors and Collaborators
French Cardiology Society
INSERM U979 (Institut Langevin)
Investigators
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Principal Investigator: Emmanuel MESSAS emmanuel.messas@aphp.fr

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Responsible Party: French Cardiology Society
ClinicalTrials.gov Identifier: NCT03234257     History of Changes
Other Study ID Numbers: 2016-03
First Posted: July 31, 2017    Key Record Dates
Last Update Posted: February 19, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by French Cardiology Society:
Carotid stenosis
stiffness
ultrafast ultrasound imaging
Plaque stability

Additional relevant MeSH terms:
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Carotid Stenosis
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases