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

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ClinicalTrials.gov Identifier: NCT03115242
Recruitment Status : Completed
First Posted : April 14, 2017
Last Update Posted : March 15, 2018
Sponsor:
Collaborators:
Jennifer YEUNG (neurologist)
Aurélien MAURIZOT (angiologist)
Simon CHABAY (angiologist)
Daniela STANCIU (neurologist)
Information provided by (Responsible Party):
Dr Jean-Michel BAUD, 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.

Condition or disease Intervention/treatment Phase
Cerebral Infarction Other: Contrast injection Sonovue® Not Applicable

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  (Clinical Trial)
Actual Enrollment : 35 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Contrast Enhanced Ultrasound of Carotid Plaque in Acute Ischemic Stroke
Actual Study Start Date : August 2015
Actual Primary Completion Date : August 2017
Actual Study Completion Date : August 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

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.




Primary Outcome Measures :
  1. Contrast enhancement of carotid plaque prevalence in ultrasound doppler [ Time Frame: Day 1 ]

Secondary Outcome Measures :
  1. Patient's demographics data [ Time Frame: Day 1 ]
  2. Patient's sonographic and MRI characteristics. [ Time Frame: 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

  3. describe the aspect of the carotid plaque on CT angiography. [ Time Frame: between 1 to 5 days ]
    NASCET stenosis and the aspect (smooth, irregular, ulcerated)

  4. Persistence , decrease or loss of contrast enhancement in ultrasound doppler. [ Time Frame: Month 6 ]
  5. Cerebral infarction recurrence [ Time Frame: Month 6 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03115242


Locations
France
Centre Hospitalier de Versailles
Le Chesnay, France, 78150
Sponsors and Collaborators
Versailles Hospital
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
OverallOfficial: Aurélien MAURIZOT, Angiologist Versailles Hospital
OverallOfficial: Simon CHABAY, Angiologist Versailles Hospital
OverallOfficial: Daniela STANCIU, Neurologist Versailles Hospital

Responsible Party: Dr Jean-Michel BAUD, Investigator coordinator, Versailles Hospital
ClinicalTrials.gov Identifier: NCT03115242     History of Changes
Other Study ID Numbers: P14/06_CUSCAS
2014-A01181-46 ( Registry Identifier: ID RCB )
First Posted: April 14, 2017    Key Record Dates
Last Update Posted: March 15, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Infarction
Cerebral Infarction
Ischemia
Pathologic Processes
Necrosis
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Stroke
Vascular Diseases
Cardiovascular Diseases