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

Primary Purpose

Cerebral Infarction

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Contrast injection Sonovue®

About this trial

This is an interventional prevention trial for Cerebral Infarction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Centre Hospitalier de Versailles

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Acute ischemic carotid stroke

Arm Description

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.

Outcomes

Primary Outcome Measures

Contrast enhancement of carotid plaque prevalence in ultrasound doppler

Secondary Outcome Measures

Patient's demographics data

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

describe the aspect of the carotid plaque on CT angiography.

NASCET stenosis and the aspect (smooth, irregular, ulcerated)

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

Cerebral infarction recurrence

Full Information

NCT ID

NCT03115242

First Posted

September 5, 2016

Last Updated

March 14, 2018

Sponsor

Versailles Hospital

Collaborators

Jennifer YEUNG (neurologist), Aurélien MAURIZOT (angiologist), Simon CHABAY (angiologist), Daniela STANCIU (neurologist)

1. Study Identification

Unique Protocol Identification Number

NCT03115242

Brief Title

Contrast Enhanced Ultrasound of Carotid Plaque in Acute Ischemic Stroke

Acronym

CUSCAS

Official Title

Contrast Enhanced Ultrasound of Carotid Plaque in Acute Ischemic Stroke

Study Type

Interventional

2. Study Status

Record Verification Date

March 2018

Overall Recruitment Status

Completed

Study Start Date

August 2015 (Actual)

Primary Completion Date

August 2017 (Actual)

Study Completion Date

August 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Versailles Hospital

Collaborators

Jennifer YEUNG (neurologist), Aurélien MAURIZOT (angiologist), Simon CHABAY (angiologist), Daniela STANCIU (neurologist)

4. Oversight

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cerebral Infarction

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

35 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Acute ischemic carotid stroke

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

Contrast injection Sonovue®

Intervention Description

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

Primary Outcome Measure Information:

Title

Contrast enhancement of carotid plaque prevalence in ultrasound doppler

Time Frame

Day 1

Secondary Outcome Measure Information:

Title

Patient's demographics data

Time Frame

Day 1

Title

Patient's sonographic and MRI characteristics.

Description

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

Time Frame

Day1

Title

describe the aspect of the carotid plaque on CT angiography.

Description

NASCET stenosis and the aspect (smooth, irregular, ulcerated)

Time Frame

between 1 to 5 days

Title

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

Time Frame

Month 6

Title

Cerebral infarction recurrence

Time Frame

Month 6

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials: