Imaging of Unstable Carotid Plaque in Patient Referred to Endarterectomy

NCT ID: NCT03353103

Last Updated: 2020-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-03

Study Completion Date

2021-06-30

Brief Summary

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This study will assess unstable plaque imaging features by using high resolution MR imaging and Sodium Fluoride F-18 PET. This is a comparative study between symptomatic and asymptomatic patient referred to carotid endateriectomy, with reference to pathologic analysis of plaque components

Detailed Description

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Conditions

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Carotid Artery Stenosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Caregivers Investigators

Study Groups

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symptomatic

Group Type ACTIVE_COMPARATOR

Sodium fluoride F-18 PET imaging

Intervention Type DRUG

prior to surgical endarterectomy each patient will undergo sodium fluoride F-18 PET imaging

asymptomatic

Group Type ACTIVE_COMPARATOR

Sodium fluoride F-18 PET imaging

Intervention Type DRUG

prior to surgical endarterectomy each patient will undergo sodium fluoride F-18 PET imaging

Interventions

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Sodium fluoride F-18 PET imaging

prior to surgical endarterectomy each patient will undergo sodium fluoride F-18 PET imaging

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age over 18 years old
* Health care system affiliation
* Referred to carotid endarterectomy
* Symptomatic patients:

* Carotid stenosis between 70 and 99% (NASCET criteria)
* TIA or minor stroke attack (RANKIN ≤ 3)
* Asymptomatic patients:

* Carotid stenosis between 70 and 99% (NASCET criteria)
* No symptoms
* Patient who has been informed of the study and has given his/her informed consent

Exclusion Criteria

* Contra indication to MRI
* Renal failure (clearance \< 30ml/mn)
* Patient with active inflammatory disease
* History of cancer
* Pregnancy or lactation
* Patient with carotid disease treated by fibrinolysis
* Patient under guardianship, or unable to understand the purpose of the study
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Caen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Caen University Hospital

Caen, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Lucie Cameliere, MD

Role: CONTACT

+33231065161

Alain Manrique, MD PhD

Role: CONTACT

+33231470287

Facility Contacts

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Lucie Camelière

Role: primary

+33231065161

Other Identifiers

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17-012

Identifier Type: -

Identifier Source: org_study_id

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