Stroke Imaging Package Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 949
- 试验地点
- 16
- 主要终点
- 90-days prognosis
研究概览
简要总结
Our study aims to explore the value of new imaging technique package in predicting early neurological deterioration (END) as well as 90-day unfavorable outcome in patients with acute ischaemic stroke.
详细描述
- Patients with acute ischemic stroke within 4.5-72h after onset were prospectively enrolled in our study and underwent standardized clinical and new imaging technique package assessment.
- New imaging technique package mainly includes conventional cranial MRI （T1,T2,T2 FLAIR,DWI, and ADC), cranial magnetic resonance angiography (MRA), and intracranial vessel wall imaging (High-Resolution Magnetic Resonance Imaging,HRMRI) as well as susceptibility weighted imaging (SWI).
- The neurofunctional fluctuation during hospitalization as well as 90-day outcomes were carefully assessed. Patients were followed up for 90-days after stroke onset.
- Our study aims to explore the value of new imaging technique package in predicting early neurological deterioration (END) as well as 90-day unfavorable outcome in patients with acute ischaemic stroke.
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
- 否
入选标准
- •patients with ischemic stroke and hospitalized during 4.5-72 hours after onset , confirmed by diffusion weighted imaging (DWI).
- •patients with stable vital signs.
- •patients who have underwent thrombolytic/intravascular therapy are allowed to enroll in the study.
排除标准
- •patients with absolute/relative contraindication to MRI (including but not confined to metal in the body and claustrophobia).
- •patients who is extremely agitated, and cannot comply with MRI exam.
- •patients who declined the consent.
结局指标
主要结局
90-days prognosis
时间窗: 90-days after stroke onset
90-days prognosis included two parts :1) stroke recurrence with new lesion on DWI;2) the modified Ranking Score (mRS) at 90-days after stroke onset.
early neurological deterioration within 3 weeks after stroke onset (END-3 weeks)
时间窗: 3 weeks after stroke onset
END-3 weeks is defined as a significant neuro-functional decline \[increment of the National Institutes of Health Stroke Scale (NIHSS) ≥ 2 points \] within 3 weeks after admission.
次要结局
未报告次要终点
研究者
Wei-Hai Xu
Associate Professor
Peking Union Medical College Hospital