Role of Immune-Inflammatory Biomarkers in Predicting Early Cognitive Impairment in Adults With Acute Basal Ganglionic Stroke
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- Incidence of Early Post-Stroke Cognitive Impairment (PSCI)
研究概览
简要总结
Post-stroke cognitive impairment (PSCI) is a common and disabling complication that affects memory, thinking, and daily functioning after a stroke. The immune-inflammatory response triggered during an acute stroke is believed to contribute to secondary brain injury and cognitive decline. Routine, low-cost blood tests that assess systemic inflammation, specifically the neutrophil-to-lymphocyte ratio (NLR), globulin-to-lymphocyte ratio (GLR), C-reactive protein-to-lymphocyte ratio (CLR), and lymphocyte-to-monocyte ratio (LMR), may serve as useful early indicators of cognitive risk.
The purpose of this observational study is to evaluate whether these inflammatory blood markers, measured during the acute hospital phase, can independently predict early-onset cognitive impairment in adult patients aged 18 to 59 years with acute basal ganglionic stroke (ischemic or primary hemorrhagic).
Participants admitted within 72 hours of symptom onset will undergo standard clinical assessments, stroke severity evaluation using the National Institutes of Health Stroke Scale (NIHSS), brain neuroimaging (CT or MRI), and routine blood testing between 24 and 72 hours post-admission. At 3 months post-stroke, participants will complete a cognitive evaluation using the Arabic-validated Montreal Cognitive Assessment (MoCA). Identifying accessible admission biomarkers could help healthcare providers recognize patients at high risk of cognitive impairment early, enabling timely monitoring and early referral for cognitive rehabilitation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 59 years.
- •First-ever acute stroke (ischemic or primary intracerebral hemorrhage) confirmed by brain CT or MRI, with documented basal ganglionic involvement.
- •Hospital admission within 72 hours of symptom onset.
- •Written informed consent provided by the patient or their legally authorized representative.
排除标准
- •Pre-existing cognitive impairment or dementia (e.g., Alzheimer's disease, vascular dementia).
- •Severe neurological or sensory deficits precluding cognitive assessment, including severe aphasia, altered level of consciousness, or significant visual or hearing impairment.
- •Severe organ dysfunction, including severe cardiac, hepatic, or renal insufficiency.
- •Medical conditions confounding systemic inflammatory markers, including active systemic infection, autoimmune disease, or recent major surgery/trauma.
- •Current or recent treatment with immunosuppressive drugs, systemic corticosteroids, or high-dose antibiotics.
研究组 & 干预措施
Adults with Acute Basal Ganglionic Stroke
Adult patients aged 18 to 59 years presenting with a first-ever acute ischemic or primary hemorrhagic stroke involving the basal ganglia (confirmed by brain CT or MRI) and admitted within 72 hours of symptom onset. Participants undergo baseline neurological assessment, stroke severity scoring via the National Institutes of Health Stroke Scale (NIHSS), and venous blood sampling between 24 and 72 hours post-admission to evaluate circulating immune-inflammatory biomarkers (neutrophil-to-lymphocyte ratio [NLR], globulin-to-lymphocyte ratio [GLR], CRP-to-lymphocyte ratio [CLR], and lymphocyte-to-monocyte ratio [LMR]). Cognitive function is evaluated at 3 months post-stroke using the Arabic-validated Montreal Cognitive Assessment (MoCA) to determine the occurrence of post-stroke cognitive impairment.
结局指标
主要结局
Incidence of Early Post-Stroke Cognitive Impairment (PSCI)
时间窗: 3 months post-stroke
Post-stroke cognitive impairment is determined using the Arabic-validated Montreal Cognitive Assessment (MoCA). The MoCA tests multiple cognitive domains (visuospatial/executive, naming, memory, attention, language, abstraction, delayed recall, and orientation), yielding a total score between 0 and 30, where higher scores indicate better cognitive performance. Early PSCI is defined as an education-adjusted MoCA score of less than 23 (\<23).
次要结局
未报告次要终点
研究者
Ahmed Hassan Hammad Abd Albadeaa
Resident of Neurology and Psychiatry
Assiut University