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

Stroke, Ischemic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05242393
• Other study ID #: 21-75-1017-2 (observational)
• Status: Recruiting
• Start date: May 1, 2018
• Est. completion date: July 31, 2024

Study information

• Verified date: February 2024
• Source: Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
• Contact: Lyudmila Korostovtseva, MD, PHD
• Phone: +79217873548
• Email: lyudmila_korosto[@]mail.ru
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: July 31, 2024
• Est. primary completion date: May 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

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

Related Conditions & MeSH terms

• Ischemia
• Ischemic Stroke
• Sleep Disorder
• Sleep Wake Disorders
• Stroke
• Stroke, Ischemic

Intervention

Other:
• No intervention is planned
No intervention is planned

Locations

Country	Name	City	State
Russian Federation	Almazov National Medical Research Centre	St Petersburg

Sponsors (1)

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

Country where clinical trial is conducted

Russian Federation, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	sleep-related respiratory characteristics: apnea-hypopnea index	assessed by routine polygraphy: apnea-hypopnea index (higher values indicate greater severity; <5 episodes/h - normal, >=5 episodes/h - pathological)	Baseline
Other	sleep-related respiratory characteristics: oxygen desaturation index	assessed by routine polygraphy: oxygen desaturation index (higher values indicate greater severity; <5 episodes/h - normal, >=5 episodes/h - pathological)	Baseline
Other	sleep-related respiratory characteristics: time under oxygen saturation <90%	assessed by routine polygraphy: time under oxygen saturation <90% (higher values indicate greater severity), in minutes	Baseline
Other	sleep-related respiratory characteristics: average oxygen saturation	assessed by routine polygraphy: average oxygen saturation (lower values indicate greater severity), in %	Baseline
Other	sleep-related respiratory characteristics: lowest oxygen saturation	assessed by routine polygraphy: lowes oxygen saturation (lower values indicate greater severity), in %	Baseline
Other	Nocturnal heart rate variability characteristics derived from nocturnal pulseoximeter data: standard deviation of normal-to-normal intervals	standard deviation of normal-to-normal intervals (msec)	Baseline
Other	Nocturnal heart rate variability characteristics derived from nocturnal pulseoximeter data: number of interval differences of successive heart beats greater than 50 ms	number of interval differences of successive heart beats greater than 50 ms	Baseline
Other	Nocturnal heart rate variability characteristics derived from nocturnal pulseoximeter data: spectral power in high-frequency power bands	spectral power in high-frequency power bands (Hz)	Baseline
Other	Nocturnal heart rate variability characteristics derived from nocturnal pulseoximeter data: spectral power in low-frequency power bands	spectral power in low-frequency power bands (Hz)	Baseline
Other	Sleep duration assessed by polysomnography	Sleep duration (minutes)	Baseline
Other	Sleep efficiency assessed by polysomnography	sleep efficiency (%)	Baseline
Other	Sleep latency assessed by polysomnography	sleep latency (minutes)	Baseline
Other	Sleep S1 stage duration assessed by polysomnography	S1 sleep stage percentage of total sleep time (%)	Baseline
Other	Sleep S2 stage duration assessed by polysomnography	S2 sleep stage percentage of total sleep time (%)	Baseline
Other	Sleep S3 stage duration assessed by polysomnography	S3 sleep stage percentage of total sleep time (%)	Baseline
Other	Rapid eye movement (REM) stage duration assessed by polysomnography	Rapid eye movement (REM) sleep stage percentage of total sleep time (%)	Baseline
Other	Wake after sleep onset time assessed by polysomnography	wake after sleep onset time (minutes), higher values indicate worse disturbance	Baseline
Other	Arousal index assessed by polysomnography	Arousal index (episodes/hour of sleep), higher values indicate worse disturbance	Baseline
Other	periodic limb movement index assessed by polysomnography	periodic limb movement index (episodes/hour of sleep), higher values indicate worse disturbance	Baseline
Other	Stroke lesion volume	Stroke lesion volume assessed by neuroimaging (computer tomography scan or magnetic resonance imaging) (ml or mm3)	Baseline
Primary	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
Primary	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
Primary	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
Primary	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	Sleep quality assessed by Pittsburgh Sleep Quality Index	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	Baseline
Secondary	Sleepiness assessed by Epworth Sleepiness Scale	a common tool to assess sleepiness; 0-24 points, higher score indicate greater sleepiness	Baseline
Secondary	Fatigue assessed by Fatigue severity Scale	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	Baseline
Secondary	Insomnia assessed by Insomnia severity index	a 7-item tool to assess the severity of insomnia, 0-5 points per each item, higher score indicates more severe insomnia	Baseline
Secondary	Chronotype assessed by Morningness-Eveningness Questionnaire	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"	Baseline