Clinical trial NCT03115242: Contrast Enhanced Ultrasound of Carotid Plaque in Acute Ischemic Stroke
Official title: Contrast Enhanced Ultrasound of Carotid Plaque in Acute Ischemic Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Infarction
Lead sponsor: Versailles Hospital
Sponsor class: OTHER
Collaborators: name: Jennifer YEUNG (neurologist)
name: Aurélien MAURIZOT (angiologist)
name: Simon CHABAY (angiologist)
name: Daniela STANCIU (neurologist)
First posted: 2017-04-14
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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

Detailed description: 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).

Eligibility criteria: 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

Primary outcomes:
measure: Contrast enhancement of carotid plaque prevalence in ultrasound doppler
timeFrame: Day 1
Secondary outcomes:
measure: Patient's demographics data
timeFrame: Day 1
measure: Patient's sonographic and MRI characteristics.
timeFrame: Day1
measure: describe the aspect of the carotid plaque on CT angiography.
timeFrame: between 1 to 5 days
measure: Persistence , decrease or loss of contrast enhancement in ultrasound doppler.
timeFrame: Month 6
measure: Cerebral infarction recurrence
timeFrame: Month 6
Other outcomes:
Locations:
city: Le Chesnay
country: France
facility: Centre Hospitalier de Versailles
Study officials:
affiliation: Versailles Hospital
name: Jennifer YEUNG, Neurologist
role: PRINCIPAL_INVESTIGATOR
affiliation: Versailles Hospital
name: Jean-Michel BAUD, Angiologist
role: PRINCIPAL_INVESTIGATOR
affiliation: Versailles Hospital
name: Aurélien MAURIZOT, Angiologist
affiliation: Versailles Hospital
name: Simon CHABAY, Angiologist
affiliation: Versailles Hospital
name: Daniela STANCIU, Neurologist
References: