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Идёт набор NCT05242393

The Role of Circadian Factors in Regulation of Neuroplasticity in Ischemic Stroke (Observational)

— Наблюдательное Stroke, Ischemic Sleep 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
В протоколе указаны: No intervention is planned.
Кому может быть актуально
Состояния в реестре: Stroke, Ischemic, Sleep Disorder. Базовые параметры: 18 лет — 80 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
Россия
Следующий шаг
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Обзор

The study is aimed at the investigation of the association of biomarkers of circadian rhythms with sleep characteristics and stroke outcome in acute stroke patients. It is designed as an observational cohort study with the retrospective and prospective longitudinal arms.

Подробное описание

In the retrospective arm of the study, the routinely collected data of patients admitted to the stroke unit with acute ischemic stroke (from 2018 till 2022) will be evaluated. In the prospective longitudinal arm, about 200-250 patients admitted to the Stroke Unit of one participating center will undergo examination including the assessment of medical records, stroke characteristics, sleep characteristics and blood sampling for the evaluation of genetic biomarkers of circadian rhythms within the first 2-3 days after admission.The assessment of stroke severity and functional deficit will be repeated at 10-14 days after stroke.

The following associations will be assessed:

* the association of genetic biomarkers of circadian rhythms with stroke outcome (the difference in neurological and functional deficit from admission to 14th day after stroke), with stroke characteristics (stroke subtype and neuroimaging stroke parameters) and with sleep characteristics. * the association of sleep characteristics with stroke outcome (the difference in neurological and functional deficit from admission to 14th day after stroke) and with stroke characteristics (stroke subtype and neuroimaging stroke parameters).

Вмешательства

  • Другое No intervention is planned
    No intervention is planned

Первичные конечные точки

  • Change in the value of National Institutes of Health Stroke Scale from baseline to 14th day after inclusion [Срок оценки: From baseline to 14th day after treatment initiation]
  • Stroke-related disability assessed by the change in modified Rankin scale from baseline to 14th day after treatment initiation [Срок оценки: From baseline to 14th day after treatment initiation]
  • Stroke-related disability assessed by the change in Rivermead Mobility Index from baseline to 14th day after treatment initiation [Срок оценки: From baseline to 14th day after treatment initiation]
  • Stroke-related disability assessed by the change in Barthel Index from baseline to 14th day after treatment initiation [Срок оценки: From baseline to 14th day after treatment initiation]
Вторичные конечные точки (5)
  • Sleep quality assessed by Pittsburgh Sleep Quality Index [Срок оценки: Baseline]
  • Sleepiness assessed by Epworth Sleepiness Scale [Срок оценки: Baseline]
  • Fatigue assessed by Fatigue severity Scale [Срок оценки: Baseline]
  • Insomnia assessed by Insomnia severity index [Срок оценки: Baseline]
  • Chronotype assessed by Morningness-Eveningness Questionnaire [Срок оценки: Baseline]

Критерии участия

Критерии включения

  • acute (symptom onset to admission <1 days) ischemic stroke
  • ischemic stroke affecting the branches of anterior cerebral artery, middle cerebral artery and posterior cerebral artery
  • age 18-80 years
  • moderate or severe stroke (National Institutes of Health Stroke Scale, NIHSS>=5)
  • intravascular stroke treatment with thrombolysis or thrombectomy leading to satisfactory reperfusion (if applicable)
  • informed consent

Критерии исключения

  • secondary parenchymal hemorrhage (>hemorrhage index -2)
  • clinically unstable or life-threatening conditions
  • known progressive neurological diseases
  • known psychiatric diseases
  • concomitant benzodiazepine medication
  • drug or alcohol abuse
  • pregnancy
  • disability to participate in the study
  • congestive heart failure with reduced ejection fraction (<=45%) or New York Heart Association (NYHA) classification III-IV functional class

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Россия · 1 центр
  • Almazov National Medical Research Centre — Saint Petersburg

Публикации

  • Korostovtseva L. Ischemic Stroke and Sleep: The Linking Genetic Factors. Cardiol Ther. 2021 Dec;10(2):349-375. doi: 10.1007/s40119-021-00231-9. Epub 2021 Jun 30. PMID 34191267
  • Bochkarev MV, Korostovtseva LS, Medvedeva EA, Rotar OP, Sviryaev YV, Zhernakova YV, Shalnova SA, Konradi AO, Chazova IE, Boitsov SA, Shlyakhto EV. [Sleep disorders and stroke: data of the esse-rf study]. Zh Nevrol Psikhiatr Im S S Korsakova. 2019;119(4. Vyp. 2):73-80. doi: 10.17116/jnevro201911904273. Russian. PMID 31317919
  • Seiler A, Camilo M, Korostovtseva L, Haynes AG, Brill AK, Horvath T, Egger M, Bassetti CL. Prevalence of sleep-disordered breathing after stroke and TIA: A meta-analysis. Neurology. 2019 Feb 12;92(7):e648-e654. doi: 10.1212/WNL.0000000000006904. Epub 2019 Jan 11. PMID 30635478

Идентификаторы

NCT: NCT05242393 · 21-75-1017-2 (observational)

Первоисточники (государственные реестры)

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