MRI Study of the Structural and Functional Rehabilitation in the Cerebral Infarction Patients With Diabetes
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- National Institute of Health Stroke Score
研究概览
简要总结
Diabetes mellitus (DM) plays an important role in the occurrence of the cerebral infarction (CI). Clinical studies have demonstrated that the CI patients with DM had a poor prognosis compared with those without DM. Previous magnetic resonance imaging (MRI) studies have shown that patients with DM had abnormalities in cerebral vessels, nerves and functions, similar with the findings in mice models. In this study, with multi-modal MRI technologies, investigators tend to observe structural and functional changes of the brain in both DM and non-DM CI patients and assess their neural rehabilitation using clinical scales in the following 6 months. Investigators also expect to find out dynamic changes of brain structure and function, to reveal the weights of factors including brain blood vessels, nerves and function remodeling related with stroke recovery, as well as the potential mechanism in CI patients with DM.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •first-ever ischemic stroke;
- •single infarct in the distribution of the middle cerebral artery;
- •no evidence of hemorrhagic infarction;
- •age greater than 18 years;
- •admission between 3 and 7 days after stroke onset;
- •National Institute of Health Stroke Score (NIHSS) score of 4 to 21 on admission and
- •no thrombolytic or recanalization therapies.
排除标准
- •atrial fibrillation;
- •history of neurological or psychiatric disorders;
- •pre-stroke modified Rankin scale (mRS) > 1;
- •life expectancy < 1 year.
结局指标
主要结局
National Institute of Health Stroke Score
时间窗: 6 months
scores ranging from 0 to 42 (the higher the score, the greater the function deficits)
Barthel index
时间窗: 6 months
score ranging from 0 (totally dependent) to 100 (completely independent)
modified Rankin scale (mRS)
时间窗: 6 months
scores range from 0 (no symptoms) to 6 (dead)
次要结局
未报告次要终点
研究者
Minming Zhang
Chief,Department of Radiology,The 2nd Affiliated Hospital of Zhejiang University, School of Medicine
Zhejiang University