Contrast Enhanced Ultrasound of Carotid Plaque in Acute Ischemic Stroke

Not Applicable

Completed

• Conditions: Cerebral Infarction
• Interventions: Other: Contrast injection Sonovue®

• Registration Number: NCT03115242
• Lead Sponsor: Versailles Hospital

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).

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2016-09-05
• Study First Submitted QC: 2017-04-10
• Study First Posted: 2017-04-14
• Primary Completion: 2017-08
• Study Completion: 2017-08
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-14
• Last Update Posted: 2018-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Acute ischemic carotid stroke	Contrast injection Sonovue®	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.

Primary Outcome Measures

Name	Time	Method
Contrast enhancement of carotid plaque prevalence in ultrasound doppler	Day 1

Secondary Outcome Measures

Name	Time	Method
Patient's demographics data	Day 1
Patient's sonographic and MRI characteristics.	Day1	confirmation of the recent character of stroke on the DWI, search for stroke sequelae and white matter disease on the FLAIR, search of the thrombus on the T2\*, search occluded artery on the 3DTOF
describe the aspect of the carotid plaque on CT angiography.	between 1 to 5 days	NASCET stenosis and the aspect (smooth, irregular, ulcerated)
Cerebral infarction recurrence	Month 6
Persistence , decrease or loss of contrast enhancement in ultrasound doppler.	Month 6

Trial Locations

Locations (1)

Centre Hospitalier de Versailles; 🇫🇷 Le Chesnay, France