Prospective, Single Center, Observational, Clinical Trial of the Effects of Cerebral Collateral Circulation on the Outcome of Leukoaraiosis in High-risk Population
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,037
- 试验地点
- 1
- 主要终点
- change in cognitive assessment scale score
研究概览
简要总结
This study observed the relationship between cerebral collateral circulation and the prognosis of leukoaraiosis in high-risk population. Cerebral collateral circulation and leukoaraiosis levels will be evaluated and followed up by magnetic resonance examination. The participants' clinical performance caused by leukoaraiosis will be assessed by a series of scales.
详细描述
- Case collection information is sent daily to clinical trial supervisors.
- The clinical trial team meets once a week to monitor the quality of clinical trials.
- The severity of the leukoaraiosis will be evaluated by a scale. The patients whose score is more than 2 will take additional magnetic resonance examination including magnetic resonance angiography (MRA) and arterial spin labeling (ASL). And their cognitive ability will be evaluated by a series of scales including Mini-Mental State Examination (MMSE) and Montreal cognitive assessment (MoCA) and gait by the short physical performance battery (SPPB).
The blood sample will be taken for biochemical detection and hair and nail samples for trace element detection. 4. Data were analyzed by regression analysis.
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
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Physical Examinees or out-patients
- •The MRI scale score ≥ 2
排除标准
- •History of stroke
- •History of malignant tumor
- •History of connective tissue disease
- •Pregnant, trying to become pregnant or within 6 weeks after delivery
- •serious infections
结局指标
主要结局
change in cognitive assessment scale score
时间窗: baseline and one year
It will be assessed by the Mini-Mental state examination (MMSE) and Montreal cognitive assessment (MoCA). Each assessment is scored 0-30, yielding a total between 0-60.
次要结局
- change in gait evaluation score(baseline and one year)
- change in mood assessment Scale score(baseline and one year)
- stroke(baseline and one year)