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Completed

NCT Number: NCT03115242

Contrast Enhanced Ultrasound of Carotid Plaque in Acute Ischemic Stroke

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier de Versailles

Le Chesnay, 78150, France

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Contrast injection Sonovue®

Other

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

Primary outcomes

  1. Contrast enhancement of carotid plaque prevalence in ultrasound doppler

    Time frame: Day 1

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Versailles Hospital

Other

Collaborators

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

Registry information

Acronym: CUSCAS

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Apr 14, 2017
Registry last updated
Mar 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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