Circulating Serum VEGF, IGF-1 and MMP-9 and Expression of Their Genes as Potential Prognostic Markers of Recovery in Post-stroke Rehabilitation - Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- changes from baseline in IGF-1 level in plasma at 3 week of rehabilitation
研究概览
简要总结
Despite increasingly effective early treatment strategies for ischemic stroke, post-stroke recovery is often incomplete and depend on spontaneous and therapeutic-induced processes related to neuroplasticity, angiogenesis and reperfusion. These processes are regulated by growth factors, neurotrophines, neurotransmitters, hormones and other factors. This study aims to search biomarkers that prognose brain repair ability and consequently estimate an outcome of stroke patients. The prognostic value of proteins VEGF, IGF-1 and MMP-9 and expression of genes VEGF, IGF-1, MMP-9 is evaluated in association with clinical scales including cognitive assessment scales and depression scales. Blood sample collection as well as scales recording are taken at baseline and 3 weeks later after rehabilitation.
详细描述
Despite increasingly effective early treatment strategies for ischemic stroke, post-stroke recovery is often incomplete and depend on spontaneous and therapeutic-induced processes related to neuroplasticity, angiogenesis and reperfusion. These processes are regulated by growth factors, neurotrophines, neurotransmitters, hormones and other factors. Recovery activity can be reflected both in the clinical assessment of the patient (based on the NIHSS or MRS scale for example) as well as on the biochemical and molecular level. This study aims to search biomarkers that prognose brain repair ability and consequently estimate an outcome of stroke patients. The prognostic value of proteins VEGF, IGF-1 and MMP-9 and expression of genes VEGF, IGF-1, MMP-9 is evaluated in association with clinical scales including cognitive assessment scales and depression scales. Furthermore, the collected data will be analyzed in relation to demographics and vascular risk factors. Blood sample collection as well as scales recording are taken at baseline and 3 weeks later after rehabilitation. The study group patients will undergo standard post-stroke rehabilitation programme provided by physiotherapist, every day for a period of 3 weeks with weekend gaps.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •subacute ischeamic stroke,
- •age over 18,
- •informed consent obtained
排除标准
- •intracerebral haemorrhage,
- •chronic or significant acute inflammatory factors,
- •neurological illness other than ischeamic stroke,
- •severe cardio-vascular disease like myocardial infarction less than 30 days, unstable angina pectoris,
- •decompensated metabolic or endocrine diseases
结局指标
主要结局
changes from baseline in IGF-1 level in plasma at 3 week of rehabilitation
时间窗: baseline and 3 weeks later
IGF-1 is a protein involved in neuroplasticity and angiogenesis processes. IGF-1 level in plasma - unit measure: ng/mL.
changes from baseline IGF-1 expression in whole blood sample at 3 week of rehabilitation
时间窗: baseline and 3 weeks later
IGF-1 is a protein involved in neuroplasticity and angiogenesis processes. IGF-1 mRNA gene expression is presented as -ΔCt
changes from baseline in VEGF level in plasma at 3 week of rehabilitation
时间窗: baseline and 3 weeks later
VEGF is a protein involved in neuroplasticity and angiogenesis processes. VEGF level in plasma - unit measure: pg/mL.
changes form baseline in Modified Rankin Scale (MRS) at 3-week rehabilitation
时间窗: baseline and 3 weeks later
Modified Rankin Scale measures degree of disability after stroke, ranges from grade 0 indicating a lack of symptoms to grade 6 indicating dead
changes form baseline in The Geriatric Depression Scale (GDS) at 3-week rehabilitation
时间窗: baseline and 3 weeks later
The Geriatric Depression Scale is self-reported validated measure of depression in older adults, consists of 15 questions, users respond in a "Yes/No" format, scores 0-4 are considered normal, more than 5 indicate depression: 5-8 mild, 9-11 moderate and 12-15 severe depressive symptoms
changes form baseline in Barthel index scale at 3-week rehabilitation
时间窗: baseline and 3 weeks later
Barthel index is a scale used to measure performance in activities of daily living, the 10 items including the Barthel Index pay attention to self-care and mobility. Total possible scores range from 0 - 20, with lower scores indicating increased disability, a score of 17 represents normal ability.
changes form baseline in National Institutes of Health Stroke Scale (NIHSS) scale at 3-week rehabilitation
时间窗: baseline and 3 weeks later
National Institutes of Health Stroke Scale is a tool used to objectively quantify the impairment caused by stroke,total score ranging from 0 to 42 and the higher the score, the more severe the stroke
changes from baseline in VEGF expression in whole blood sample at 3 week of rehabilitation
时间窗: baseline and 3 weeks later
VEGF is a protein involved in neuroplasticity and angiogenesis processes. VEGF mRNA gene expression is presented as -ΔCt
changes from baseline in MMP-9 level in plasma at 3 week of rehabilitation
时间窗: baseline and 3 weeks later
MMP-9 is a protein involved in neuroplasticity and angiogenesis processes. MMP-9 level in plasma - unit of measure: pg/mL.
changes from baseline in MMP-9 expression in whole blood sample at 3 week of rehabilitation
时间窗: baseline and 3 weeks later
MMP-9 is a protein involved in neuroplasticity and angiogenesis processes. MMP-9 mRNA gene expression is presented as -ΔCt
changes form baseline in Mini Mental State Examination (MMSE) scale at 3-week rehabilitation
时间窗: baseline and 3 weeks later
Mini Mental State Examination is effective, screening tool for cognitive impairment, the maximum score for the MMSE is 30, a cut-off score of 23/24 (or below) indicates dementia, a score of 25 or higher is classed as normal
次要结局
未报告次要终点