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

NCT05242393 | Recruiting

• 1 other identifier: 21-75-1017-2 (observational)
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke, Ischemic; Sleep Disorder

Keywords

neuroplasticity; cognitive dysfunction; disability; circadian rhythm; functional deficit; stroke outcome; sleep-disordered breathing; heart rate variability

Outcome Measures

Primary Outcomes (4)

• Change in the value of National Institutes of Health Stroke Scale from baseline to 14th day after inclusion

  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

  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

  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)

  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

  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

  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

  a common scale used to measure performance in activities of daily living, 0-100 scores, higher scores define better performance

  From baseline to 14th day after treatment initiation

Secondary Outcomes (5)

• Sleep quality assessed by Pittsburgh Sleep Quality Index

  Baseline

• Sleepiness assessed by Epworth Sleepiness Scale

  Baseline

• Fatigue assessed by Fatigue severity Scale

  Baseline

• Insomnia assessed by Insomnia severity index

  Baseline

• Chronotype assessed by Morningness-Eveningness Questionnaire

  Baseline

Other Outcomes (20)

• sleep-related respiratory characteristics: apnea-hypopnea index

  Baseline

• sleep-related respiratory characteristics: oxygen desaturation index

  Baseline

• sleep-related respiratory characteristics: time under oxygen saturation <90%

  Baseline

Study Arms (2)

Retrospective cohort

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.

Other: No intervention is planned

Prospective cohort

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).

Other: No intervention is planned

Interventions

No intervention is planned OTHER

No intervention is planned

Prospective cohort; Retrospective cohort

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited from the patients with confirmed acute ischemic stroke admitted to the Stroke Unit

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Almazov National Medical Research Centre

Saint Petersburg, 197341, Russia

RECRUITING

Related Publications (3)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, serum, saliva

MeSH Terms

Conditions

Ischemic Stroke; Sleep Wake Disorders; Cognitive Dysfunction; Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Cognition Disorders; Neurocognitive Disorders; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias

Study Officials

• Lyudmila Korostovtseva, MD, PhD

  Almazov National Medical Research Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lyudmila Korostovtseva, MD, PHD

CONTACT

+79217873548; lyudmila_korosto@mail.ru

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Researcher, Department for Hypertension

Study Record Dates

• First Submitted: January 26, 2022
• First Posted: February 16, 2022
• Study Start: May 1, 2018
• Primary Completion: January 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)