Transmission Electron Microscopy Images for Platelet Ultrastructural Criteria Before and After the Onset of an Antiplatelet Agent

Обзор

The aim of the pilot study is to collect all the ultrastructural platelet characteristics by transmission electron microscopy before and after the onset of an antiplatelet treatment in patients hospitalized for an ischemic stroke ; and to assess recurrence of Ischemic Cerebral Accident (ICA) at 6 months in patients hospitalized for Ischemic stroke.

Подробное описание

Ischaemic stroke is the leading cause of adult disability. Thus, a strategy based on an efficient antiplatelet therapy has been developed to prevent platelet activation occurring in the acute phase of non-cardioembolic ischemic stroke.

The biological monitoring of the antiplatelet therapy with available platelet function assays do not provide a global integrative approach considering all the mechanisms involved in platelet activation.

Platelet transmission electron microscopy recently validated for assessing distinct ultrastructural abnormalities is a reliable morphological platelet structural analysis tool.

Ultrastructural criteria could be identified and be useful for the assessment of the degree of platelet activation and thus the biological efficiency of antiplatelet agents. All the activation transduction signals are integrated and all antiplatelet agents can be assessed.

The aim of the pilot study is to collect all the ultrastructural platelet characteristics by transmission electron microscopy before and after the onset of an antiplatelet treatment in patients hospitalized for an ischemic stroke.

Investigators expect to identify ultrastructural characteristics that will be correlated with the platelet degree of activation to guide clinicians in decision-making regarding the antiplatelet therapy strategy.

Вмешательства

• Биопрепарат Blood collection before antiplatelet treatment
  Blood sample (17ml) will be collected in the neurovascular department to be processed for platelet ultrastructural analysis before the onset of an antiplatelet treatment
• Биопрепарат Blood collection after antiplatelet treatment
  A follow-up will be carried out 5 to 8 days after the initiation of the treatment. A blood test will be taken in the NeuroVascular Unit

Первичные конечные точки

• Morphology of the platelet : [Срок оценки: Day 5]
• Type of granules in the platelet [Срок оценки: Day 5]
• Distribution of mitochondria, glycogen and dense tubular system in platelets [Срок оценки: Day 5]
• Structure of open canalicular system in platelets [Срок оценки: Day 5]
• Number of patients with a microtubular ring on the equatorial section plane (peripheral or centralized) in platelets [Срок оценки: Day 5]

Вторичные конечные точки (1)

• The incidence of a composite endpoint [Срок оценки: Month 6]

Критерии участия

Критерии включения

• Social security affiliation
• Signed informed consent
• patients hospitalized for an non cardioembolic ischemic stroke requiring the onset of an antiplatelet therapy according to the usual guidelines recommendations

Критерии исключения

Contraindications regarding antiplatelet agent(s) and/or at least one excipient according to Summary of Product Characteristics (SPC).

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

Профилактика

Центры проведения

Франция · 1 центр

• Centre Hospitalier Universitaire de St-Etienne — Saint-Etienne

Публикации

• Mallouk N, Garcin A, Li G, Epinat M, Szczepaniak C, Hien OF, Mismetti P, Garnier P. Platelet transmission electron microscopy for the assessment of poor biological response to antiplatelet agent: pilot descriptive and prospective study - ELECTROSTROKE. BMJ Open. 2022 Apr 4;12(4):e050060. doi: 10.1136/bmjopen-2021-050060. PMID 35379612

Идентификаторы

NCT: NCT05004233 · 20CH026 · 2021-A00292-39

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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