The Role of Circadian Factors in Regulation of Neuroplasticity in Ischemic Stroke (Observational)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Stroke-related disability assessed by the change in Rivermead Mobility Index from baseline to 14th day after treatment initiation
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Stroke-related disability assessed by the change in Rivermead Mobility Index from baseline to 14th day after treatment initiation
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
次要结局
- Sleep quality assessed by Pittsburgh Sleep Quality Index(Baseline)
- Sleepiness assessed by Epworth Sleepiness Scale(Baseline)
- Insomnia assessed by Insomnia severity index(Baseline)
- Fatigue assessed by Fatigue severity Scale(Baseline)
- Chronotype assessed by Morningness-Eveningness Questionnaire(Baseline)
研究者
Lyudmila Korostovtseva
Senior Researcher, Department for Hypertension
Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health