Contrast Enhanced Ultrasound of Carotid Plaque in Acute Ischemic Stroke

NCT ID: NCT03115242

Last Updated: 2018-03-15

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

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2017-08-31

Brief Summary

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This is a biomedical, single-center, and prospective study of a consecutive patients cohort in acute ischemic stroke with carotid plaque.

Detailed Description

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The main objective of this study is to evaluate the prevalence of the contrast taking carotid plaques in these acute ischemic strokes.

The secondary objectives are:

* to determine the clinical, sonographic, CT scanner and MRI characteristics of patients in constituted acute cerebral ischemia with carotid atherosclerotic plaque taking contrast to the doppler ultrasound.
* to explore of the plaque contrast enhancement at 6 months (new injection).

Conditions

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Cerebral Infarction

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Acute ischemic carotid stroke

Patients hospitalized in the neurovascular intensive care unit for an acute ischemic stroke with a carotid plaque responding to inclusion criteria.

These patients receive a contrast injection Sonovue® will be performed during the neck vessels doppler ultrasound.

Group Type EXPERIMENTAL

Contrast injection Sonovue®

Intervention Type OTHER

In addition to standardized assessment routine care, a contrast injection will be performed during the neck vessels doppler ultrasound.

Interventions

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Contrast injection Sonovue®

In addition to standardized assessment routine care, a contrast injection will be performed during the neck vessels doppler ultrasound.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* All patients aged at least 18 years hospitalized with ischemic stroke signs in the carotid territory, objectified on brain MRI with positive DWI.
* Carotid plaque \> 2.5 mm thickness in the ipsilateral carotid territory to the AIC, low echogenicity (Type 1, 2, 3, and 4a of the classification Geroulakos) measured by the assessment "GSM" (median gray level).
* Free and informed consent patient or his representative for contrast injection microbubble.
* Affiliated to health insurance.

Exclusion Criteria

* Severe cerebral infarction with NIHSS\> 25
* No-indications to the contrast medium injection
* Recent myocardial infarction, unstable angina.
* Heart failure stage III / IV New York Heart Association.
* Cardiac shunt left-right, respiratory distress.
* Allergy to albumin or contrast agents.
* Carotid plaques and hyperechoic calcified (however these plaques will be counted to determine their prevalence in acute AIC).
* Carotid dissection
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jennifer YEUNG (neurologist)

UNKNOWN

Sponsor Role collaborator

Aurélien MAURIZOT (angiologist)

UNKNOWN

Sponsor Role collaborator

Simon CHABAY (angiologist)

UNKNOWN

Sponsor Role collaborator

Daniela STANCIU (neurologist)

UNKNOWN

Sponsor Role collaborator

Versailles Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dr Jean-Michel BAUD

Investigator coordinator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jennifer YEUNG, Neurologist

Role: PRINCIPAL_INVESTIGATOR

Versailles Hospital

Jean-Michel BAUD, Angiologist

Role: PRINCIPAL_INVESTIGATOR

Versailles Hospital

Aurélien MAURIZOT, Angiologist

Role:

Versailles Hospital

Simon CHABAY, Angiologist

Role:

Versailles Hospital

Daniela STANCIU, Neurologist

Role:

Versailles Hospital

Locations

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Centre Hospitalier de Versailles

Le Chesnay, , France

Site Status

Countries

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France

Other Identifiers

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2014-A01181-46

Identifier Type: REGISTRY

Identifier Source: secondary_id

P14/06_CUSCAS

Identifier Type: -

Identifier Source: org_study_id

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