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Идёт набор NCT04663399

IMMunological resPonse Assessment afteR Acute iSchemic Stroke Treated With Endovascular Therapy (IMPRESS)

Наблюдательное Ischemic Stroke Thrombectomy

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: Prospective patient.
Кому может быть актуально
Состояния в реестре: Ischemic Stroke, Thrombectomy. 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 →
Официальное название

IMMunological resPonse Assessment afteR Acute iSchemic Stroke Treated With Endovascular Therapy

Обзор

IMPRESS study aims to describe the immuno-inflammatory and thrombo-inflammatory profiles during the first 24/36 hours of treatment of patients suffering from AIC treated with TM, and to study the possible impact of these profiles on the functional prognosis at 3 and 12 months of AIC treatment.

Подробное описание

Stroke is the second leading cause of death worldwide, the leading cause of acquired disability and the second leading cause of dementia. Ischaemic strokes account for 80% of strokes, 40% of which are caused by occlusion of a large-calibre artery in the polygon of Willis. In 2020, the treatment focuses on recanalisation, as quickly as possible. This is achieved medically by intravenous thrombolysis (IVT) and, since 2015, by mechanical thrombectomy (MT) in cases of proximal anterior artery occlusion. Thrombectomy has revolutionised the management of AIC, as it results in over 90% recanalisation at the end of treatment. However, more than half of patients managed between 3 and 6 hours, and recanalised with TM, remain dependent at 3 months.

In recent years, numerous studies (mainly preclinical) have highlighted the impact of the systemic and cerebral inflammatory reaction following AIC. Interestingly, this immuno-inflammatory reaction seems to follow a precise chronology and involves various immune players. Several preclinical studies in rodents have shown that this immunoinflammatory response appears to be strongly associated with prognosis (final stroke volume, disability and post-stroke dementia).

The absence of reliable biomarkers in humans to better describe and assess the chronology of the immuno-inflammatory profile after stroke appears to be a fundamental limitation to the introduction of innovative treatments. These biomarkers would make it possible to select and accurately assess the time required to introduce treatments such as immunomodulatory therapies (Natalizumab, Fingolimod, Copaxone, cell therapy, etc.). New studies seem necessary to identify peripheral biomarkers of the immuno-inflammatory state (cytokines, precise cell typing), and of thrombo-inflammation (NETose markers, neutrophil markers) and their consequences on disability after an ACI.

The aim of the IMPRESS study is therefore to describe the immuno-inflammatory and thrombo-inflammatory profiles during the first 24 +/-12 hours of the management of patients suffering from AIC treated with TM, and to study the possible impact of these profiles on the functional prognosis 3 and 12 months after the AIC has been managed.

Вмешательства

  • Другое Prospective patient
    The immuno-inflammatory and thrombo-inflammatory profiles will be evaluated at inclusion, and at 24 hours +/- 12 hours of the reperfusion treatment.

Первичные конечные точки

  • Immuno-inflammatory and thrombo-inflammatory profiles in patients suffering from AIC and treated with mechanical Thrombectomie. [Срок оценки: 21 months]

Критерии участия

Критерии включения

  • Patient with an acute ischemic stroke for which treatment with mechanical thrombectomy is indicated, whether or not thrombectomy is performed,
  • Having received informed information about the study and having signed a consent to participate in the study (if this is not possible: information and consent of the trusted support person or family member if present; emergency inclusion if absent);
  • Affiliated or beneficiary of a social security scheme or equivalent.

Non inclusion Criteria:

  • Pregnant or breast-feeding women
  • Patient benefiting from a legal protection measure

Критерии исключения

None.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Франция · 1 центр
  • Hôpital Fondation Adolphe de Rothschild — Paris

Идентификаторы

NCT: NCT04663399 · BMR_2020_32

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗