Contrast Enhanced Ultrasound of Carotid Plaque in Acute Ischemic Stroke

Cerebral Infarction Clinical Trial

— CUSCAS  

Official title:

Contrast Enhanced Ultrasound of Carotid Plaque in Acute Ischemic Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03115242
• Other study ID #: P14/06_CUSCAS
• Secondary ID: 2014-A01181-46
• Status: Completed
• Phase: N/A
• First received: September 5, 2016
• Last updated: March 14, 2018
• Start date: August 2015
• Est. completion date: August 2017

Study information

• Verified date: March 2018
• Source: Versailles Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Infarction
• Infarction

Intervention

Other:
• Contrast injection Sonovue®
In addition to standardized assessment routine care, a contrast injection will be performed during the neck vessels doppler ultrasound.

Locations

Country	Name	City	State
France	Centre Hospitalier de Versailles	Le Chesnay

Sponsors (5)

Lead Sponsor	Collaborator
Versailles Hospital	Aurélien MAURIZOT (angiologist), Daniela STANCIU (neurologist), Jennifer YEUNG (neurologist), Simon CHABAY (angiologist)

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Contrast enhancement of carotid plaque prevalence in ultrasound doppler		Day 1
Secondary	Patient's demographics data		Day 1
Secondary	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
Secondary	describe the aspect of the carotid plaque on CT angiography.	NASCET stenosis and the aspect (smooth, irregular, ulcerated)	between 1 to 5 days
Secondary	Persistence , decrease or loss of contrast enhancement in ultrasound doppler.		Month 6
Secondary	Cerebral infarction recurrence		Month 6