Меню
Идёт набор NCT06133179

Super-Resolution Ultrasound of the Brain in 3D

Без фазы С лечением Cerebral Stroke

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Transtemporal ultrasound with contrast product (Sonovue).
Кому может быть актуально
Состояния в реестре: Cerebral Stroke. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Франция
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Pilot Study of the Characterization of Subacute Ischemic Cerebrovascular Accidents in the Region of the Middle Cerebral Artery by 3D Ultrasound Localization Microscopy (ULM) with a Research Ultrasound System and Non-marketed 2D Matrix Probe.

Обзор

The goal of this proof of concept study is to determine if the visualization of the middle cerebral artery and its perforators, through 3D transtemporal ultrasound imaging, is possible thanks to an off-line analysis by 3D ultrasound localization microscopy. Visualization of these vessels would allow us to conclude on the presence, or absence, of an ischemic stroke in the region of the middle cerebral artery. To answer the question asked, 20 participants who suffered a stroke will carry out a transtemporal ultrasound examination specifically for research in the 7 days following his stroke. The data obtained will be analyzed by the CNRS medical imaging laboratory, in order to characterize the presence of a stroke and to compare the data obtained with that of standard examinations (CT and MRI).

Вмешательства

  • Процедура Transtemporal ultrasound with contrast product (Sonovue)
    During their hospitalization and in the 7 days following their stroke, all patients will perform a transtemporal ultrasound including the use of Sonovue contrast product. The examination will last 1 hour and will be carried out on the opposite side of the stroke then on the side of the stroke

Первичные конечные точки

  • Describe the vascular mapping obtained by 3D transcranial ULM of patients with ischemic stroke in the territory of the middle cerebral artery and its perforators [Срок оценки: Day 1]
  • Describe the vascular mapping obtained by 3D transcranial ULM of patients with ischemic stroke in the territory of the middle cerebral artery and its perforators [Срок оценки: Day 1]
  • Describe the vascular mapping obtained by 3D transcranial ULM of patients with ischemic stroke in the territory of the middle cerebral artery and its perforators [Срок оценки: Day 1]
  • Describe the vascular mapping obtained by 3D transcranial ULM of patients with ischemic stroke in the territory of the middle cerebral artery and its perforators [Срок оценки: Day 1]
  • Describe the vascular mapping obtained by 3D transcranial ULM of patients with ischemic stroke in the territory of the middle cerebral artery and its perforators [Срок оценки: Day 1]
Вторичные конечные точки (3)
  • Compare 3D ULM with standard stroke imaging methods (TOF MRI and DWI) [Срок оценки: Day 1]
  • Compare 3D ULM with standard stroke imaging methods (TOF MRI and DWI) [Срок оценки: Day 1]
  • Compare 3D ULM with standard stroke imaging methods (TOF MRI and DWI) [Срок оценки: Day 1]

Критерии участия

Критерии включения

  • Patient aged 18 and over
  • Hospitalized patient with ischemic stroke in the deep territory of the middle cerebral artery
  • Patient with lesion observable on MRI
  • Patient included between 24 hours and 7 days after the ischemic stroke
  • Patient with a temporal window which allows soundproofing of the polygon of Willis and the middle cerebral artery
  • Patient having signed free, informed and written consent
  • Patient affiliated to a social security system (excluding AME)

Критерии исключения

  • Contralateral middle cerebral artery territory stroke or contralateral middle cerebral artery occlusion
  • Patient with contraindication to Doppler ultrasound with contrast (right-left shunt, severe pulmonary arterial hypertension)
  • Patient with hypersensitivity to the active princip of Sonovue (sulfur hexafluoride) or these excipients
  • Patient with uncontrolled systemic hypertension
  • Patient with respiratory distress syndrome
  • Patient under guardianship or curatorship
  • Pregnant or breastfeeding patient (positive blood pregnancy test during hospitalization)
  • Patient with damaged skin at the temporal level
  • Patient having presented in the 7 days preceding inclusion an acute coronary syndrome or suffering from unstable ischemic heart disease

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Диагностика

Центры проведения

Франция · 1 центр
  • Hôpital Bichat — Paris

Идентификаторы

NCT: NCT06133179 · APHP230511

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗