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

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

Recruiting
18-80 years
All
Phase N/A

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Overview

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.

Description

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).

Eligibility

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study details
    Stroke
    Ischemic
    Sleep Disorder

NCT05242393

Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health

14 August 2025

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