Contrast Enhanced Ultrasound of Carotid Plaque in Acute Ischemic Stroke (CUSCAS)

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

Study Overview

• Status: Completed
• Conditions: Cerebral Infarction
• Intervention / Treatment: Other: Contrast injection Sonovue®

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 Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Le Chesnay, France, 78150
    • Centre Hospitalier de Versailles

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Contrast injection Sonovue®; In addition to standardized assessment routine care, a contrast injection will be performed during the neck vessels doppler ultrasound.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Contrast enhancement of carotid plaque prevalence in ultrasound doppler	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient's demographics data		Day 1
Patient's sonographic and MRI characteristics.	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	Day1
describe the aspect of the carotid plaque on CT angiography.	NASCET stenosis and the aspect (smooth, irregular, ulcerated)	between 1 to 5 days
Persistence , decrease or loss of contrast enhancement in ultrasound doppler.		Month 6
Cerebral infarction recurrence		Month 6

Collaborators and Investigators

• Sponsor: Versailles Hospital
• Collaborators: Jennifer YEUNG (neurologist); Aurélien MAURIZOT (angiologist); Simon CHABAY (angiologist); Daniela STANCIU (neurologist)
• Investigators: Principal Investigator: Jennifer YEUNG, Neurologist, Versailles Hospital; Principal Investigator: Jean-Michel BAUD, Angiologist, Versailles Hospital; Aurélien MAURIZOT, Angiologist, Versailles Hospital; Simon CHABAY, Angiologist, Versailles Hospital; Daniela STANCIU, Neurologist, Versailles Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2015
• Primary Completion (Actual): August 1, 2017
• Study Completion (Actual): August 1, 2017

Study Registration Dates

• First Submitted: September 5, 2016
• First Submitted That Met QC Criteria: April 10, 2017
• First Posted (Actual): April 14, 2017

Study Record Updates

• Last Update Posted (Actual): March 15, 2018
• Last Update Submitted That Met QC Criteria: March 14, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Stroke; Brain Infarction; Infarction; Ischemic Stroke; Cerebral Infarction
• Other Study ID Numbers: P14/06_CUSCAS; 2014-A01181-46 (Registry Identifier: ID RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided