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Идёт набор NCT05645081

Extracellular Vesicles and Dysregulated Coagulation in the Prediction of Stroke

— Наблюдательное Stroke, Ischemic Transient Ischemic Attack Coagulation Disorder

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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Stroke, Ischemic, Transient Ischemic Attack, Coagulation Disorder. 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
Великобритания
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

PREDICT-EV; the Association of Extracellular Vesicles and Dysregulated Coagulation in the Prediction of Stroke

Обзор

Annually 100,000 strokes occur, placing stroke as the largest cause of disability in the UK. 90% of strokes are preventable, leading to national focus on programmes including "The National Stroke Programme" to act on preventing, treating, and improving post-stroke care. Importantly, over 25% of ischaemic stroke sufferers have previously had a Transient Ischaemic Attack (TIA), which presents the biggest concern for TIA patients. There are no measures which reliably identify TIA patients most likely to suffer a stroke. Novel biomarkers for predicting stroke are key to addressing this problem. The PREDICT-EV study aims to screen 300 TIA patients and follow them over 12-months. The investigators will determine if a novel biomarker we've identified to increase thrombotic risk (endothelial derived extracellular vesicles) and the resulting increased prothrombin time is associated with patients at highest risk of stroke.

Первичные конечные точки

  • Change in the endothelial derived extracellular vesicle population [Срок оценки: 3 years]
  • Change in patient Prothrombin time [Срок оценки: 3 years]

Критерии участия

The inclusion criteria for phase 1 (initial patient recruitment) will be:

  • Patients with or without diagnosis of TIA made by a physician working in stroke medicine, sufficiently so to start post-TIA care or so that no further investigation is thought necessary to confirm or refute the diagnosis.
  • TIA confirmed patient has been prescribed antiplatelet drugs or anticoagulants.
  • Patients must be aged > 18 years.
  • Patients are taking an ordinary diet by mouth.

The inclusion criteria for phase 2 (patient representing with stroke) will be:

  • Radiological evidence, on CT and/or MR imaging of the brain of cerebral infarction, with or without secondary haemorrhage.
  • The underlying mechanism of cerebral infarction is embolic from a cardiac source (e.g. atrial fibrillation), atherothromboembolic (from aorta or other large vessels in the neck) or in-situ thrombosis. No further investigations are thought necessary to confirm or refute the diagnosis.
  • No further investigations are thought necessary to confirm or refute the diagnosis.
  • Patients must be aged >18 years.
  • Patients must not be pregnant or breast feeding.
  • Patients are taking an ordinary diet by mouth. Exclusion Criteria

The Exclusion criteria for phase 1 (initial patient recruitment) will be:

  • Inability to give consent.
  • Inability to feed by mouth.
  • Short life expectancy.
  • Pregnancy or breastfeeding.
  • Symptoms are readily explained by medical problems not involving focal cerebral ischaemia.

The Exclusion criteria for phase 2 (patient representing with stroke) will be:

  • Patients who have not previously given consent for follow up blood sampling.
  • Patients who are unable to feed by mouth.
  • Patients in whom life expectancy is short.
  • Patient is pregnant or breast feeding.

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Случай-контроль

Центры проведения

Великобритания · 1 центр
  • Prince Charles Hospital — Merthyr Tydfil

Идентификаторы

NCT: NCT05645081 · CT/1245/281530/19/20

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗