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

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

Status: Enrolling

Conditions: Sleep Disorder; Stroke, Ischemic

Treatments: Other: No intervention is planned

Study type: Observational

Funder types: Other

Identifiers

NCT05242393

21-75-1017-2 (observational)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 250 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

250 participants in 2 patient groups

Retrospective cohort

Description:

Patients with acute ischemic stroke admitted to the Stroke Unit of one participating center in 2018-2022. The data collected within clinical routine will be analyzed including stroke characteristics at baseline and at discharge (10-14 days after admission), neuroimaging data, sleep characteristics (routine polygraphy study), heart rate variability, routine blood tests.

Treatment:

Other: No intervention is planned

Prospective cohort

Description:

Approximately 200-250 patients with acute ischemic stroke admitted to the Stroke Unit of one participating center in 2022-2024 will undergo the assessment of medical records, stroke characteristics, the assessment of sleep characteristics and blood sampling for the evaluation of genetic biomarkers of circadian rhythms at baseline (within 2-3 days of admission) and at 10-14 days (at discharge).

Treatment:

Other: No intervention is planned