Contrast Enhanced Ultrasound of Carotid Plaque in Acute Ischemic Stroke

NCT03115242 | Completed

• 2 other identifiers: P14/06_CUSCAS2014-A01181-46
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cerebral Infarction

Outcome Measures

Primary Outcomes (1)

• Contrast enhancement of carotid plaque prevalence in ultrasound doppler

  Day 1

Secondary Outcomes (5)

• Patient's demographics data

  Day 1

• Patient's sonographic and MRI characteristics.

  Day1

• describe the aspect of the carotid plaque on CT angiography.

  between 1 to 5 days

• Persistence , decrease or loss of contrast enhancement in ultrasound doppler.

  Month 6

• Cerebral infarction recurrence

  Month 6

Study Arms (1)

Acute ischemic carotid stroke

EXPERIMENTAL

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®

Interventions

Contrast injection Sonovue® OTHER

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

Acute ischemic carotid stroke

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Versailles Hospital: lead
• Jennifer YEUNG (neurologist): collaborator
• Aurélien MAURIZOT (angiologist): collaborator
• Simon CHABAY (angiologist): collaborator
• Daniela STANCIU (neurologist): collaborator

Study Sites (1)

Centre Hospitalier de Versailles

Le Chesnay, 78150, France

Location

MeSH Terms

Conditions

Cerebral Infarction

Condition Hierarchy (Ancestors)

Brain Infarction; Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Vascular Diseases; Cardiovascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Jennifer YEUNG, Neurologist

  Versailles Hospital

  PRINCIPAL INVESTIGATOR

• Jean-Michel BAUD, Angiologist

  Versailles Hospital

  PRINCIPAL INVESTIGATOR

• Aurélien MAURIZOT, Angiologist

  Versailles Hospital

• Simon CHABAY, Angiologist

  Versailles Hospital

• Daniela STANCIU, Neurologist

  Versailles Hospital

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator coordinator

Study Record Dates

• First Submitted: September 5, 2016
• First Posted: April 14, 2017
• Study Start: August 1, 2015
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: March 15, 2018

Record last verified: 2018-03

Locations

FR (1)