The Role of Circadian Factors in Regulation of Neuroplasticity in Ischemic Stroke (Observational)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: No intervention is planned.
- Who it may be relevant to
- Registry conditions: Stroke, Ischemic, Sleep Disorder. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Russia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
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).
Interventions
- Other No intervention is planned
No intervention is planned
Primary outcome measures
- Change in the value of National Institutes of Health Stroke Scale from baseline to 14th day after inclusion [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: From baseline to 14th day after treatment initiation]
Secondary outcome measures (5)
- Sleep quality assessed by Pittsburgh Sleep Quality Index [Time frame: Baseline]
- Sleepiness assessed by Epworth Sleepiness Scale [Time frame: Baseline]
- Fatigue assessed by Fatigue severity Scale [Time frame: Baseline]
- Insomnia assessed by Insomnia severity index [Time frame: Baseline]
- Chronotype assessed by Morningness-Eveningness Questionnaire [Time frame: Baseline]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Russia · 1 center
- Almazov National Medical Research Centre — Saint Petersburg
Publications
- 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
Identifiers
NCT: NCT05242393 · 21-75-1017-2 (observational)