NCT03234257

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 18, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 10, 2017

Completed
21 days until next milestone

First Posted

Study publicly available on registry

July 31, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 5, 2019

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
Last Updated

August 9, 2021

Status Verified

August 1, 2021

Enrollment Period

2 years

First QC Date

July 10, 2017

Last Update Submit

August 6, 2021

Conditions

Carotid Stenosis

Keywords

Carotid stenosisstiffnessultrafast ultrasound imagingPlaque stability

Outcome Measures

Primary Outcomes (1)

  • 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.

    the day of enrollment

Secondary Outcomes (6)

  • stiffness between plaque and its adjacent arterial segments

    The day of enrollment.

  • correlation between the plaque's stiffness and the histological quantification of the fibrous tissue.

    at the end of the study (5 months)

  • 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

    the day of enrollment

  • the quantification of the wall shear stress evaluated by UF Doppler between stable and unstable plaque.

    the day of enrollment

  • +1 more secondary outcomes

Study Arms (1)

patients with carotid stenosis.

OTHER

asymptomatic patients with carotid stenosis.

Device: UF-ultrasound

Interventions

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

patients with carotid stenosis.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Europeen Georges Pompidou

Paris, 75015, France

Location

Related Publications (1)

  • 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.

    PMID: 34181190DERIVED

MeSH Terms

Conditions

Carotid Stenosis

Condition Hierarchy (Ancestors)

Carotid Artery DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Emmanuel MESSAS

    emmanuel.messas@aphp.fr

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2017

First Posted

July 31, 2017

Study Start

May 18, 2017

Primary Completion

May 5, 2019

Study Completion

September 30, 2020

Last Updated

August 9, 2021

Record last verified: 2021-08

Locations

FR(1)