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

Recruiting

• Conditions: Stroke, Ischemic; Sleep Disorder
• Interventions: Other: No intervention is planned

• Registration Number: NCT05242393
• Lead Sponsor: Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health

Brief Summary

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.

Detailed 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).

Study Timeline

• Study Start: 2018-05-01
• Study First Submitted: 2022-01-26
• Study First Submitted QC: 2022-02-05
• Study First Posted: 2022-02-16
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-23
• Last Update Posted: 2024-02-26
• Primary Completion: 2024-05-30
• Study Completion: 2024-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Retrospective cohort	No intervention is planned	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.
Prospective cohort	No intervention is planned	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).

Primary Outcome Measures

Name	Time	Method
Stroke-related disability assessed by the change in Rivermead Mobility Index from baseline to 14th day after treatment initiation	From baseline to 14th day after treatment initiation	a standardized scale used to assess mobility in patients with neurological deficits, a maximum of 15 points is possible; higher scores indicate better mobility performance
Stroke-related disability assessed by the change in modified Rankin scale from baseline to 14th day after treatment initiation	From baseline to 14th day after treatment initiation	values of modified Rankin scale (scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke, from 0 (no symptoms) to 6 (dead) points)
Change in the value of National Institutes of Health Stroke Scale from baseline to 14th day after inclusion	From baseline to 14th day after treatment initiation	National Institutes of Health Stroke Scale (NIHSS) is a tool used to objectively quantify the impairment caused by a stroke, 0-42 scores, higher scores characterize worse impairment
Stroke-related disability assessed by the change in Barthel Index from baseline to 14th day after treatment initiation	From baseline to 14th day after treatment initiation	a common scale used to measure performance in activities of daily living, 0-100 scores, higher scores define better performance

Secondary Outcome Measures

Name	Time	Method
Sleep quality assessed by Pittsburgh Sleep Quality Index	Baseline	Pittsburgh Sleep Quality Index is a self-rated questionnaire which assesses sleep quality and disturbances over the last (previous) 1-month (a retrospective assessment) time interval, Each of the sleep components yields a score ranging from 0 to 3, with 3 indicating the greatest dysfunction. The sleep component scores are summed to yield a total score ranging from 0 to 21 with the higher total score indicating worse sleep quality
Sleepiness assessed by Epworth Sleepiness Scale	Baseline	a common tool to assess sleepiness; 0-24 points, higher score indicate greater sleepiness
Insomnia assessed by Insomnia severity index	Baseline	a 7-item tool to assess the severity of insomnia, 0-5 points per each item, higher score indicates more severe insomnia
Fatigue assessed by Fatigue severity Scale	Baseline	a common 9-item tool used to determine and quantify fatigue as subjective feeling of exhaustion, persisting lack of energy and rapid inanition, 9-63 points, higher score indicates more severe fatigue
Chronotype assessed by Morningness-Eveningness Questionnaire	Baseline	a common 19-item tool to estimate individual chronotype, a score ranging from 16 to 86; scores of 41 and below indicate "evening types", scores of 59 and above indicate "morning types", scores between 42-58 indicate "intermediate types"

Trial Locations

Locations (1)

Almazov National Medical Research Centre; 🇷🇺 St Petersburg, Russian Federation