MR-based Stroke Mechanism and Future Risk Score
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 961
- 试验地点
- 1
- 主要终点
- modified Rankin Score
研究概览
简要总结
To explore prediction model for outcome of patients with acute ischemic stroke using multimodal Magnetic Resonance(MR) imaging was a multicenter prospective observational study supported by National Natural Science Foundation of China. Imaging evaluation of hemodynamic status and antegrade flow were assessed. Patients were followed up to record radiological and clinical outcome. The study recruited patients from 11 centers located in 10 provinces or province-level municipalities across the northeast to the southeast of China mainland.
详细描述
Patients:
Patients with cerebral ischemia sympton of onset in 24 hours were included. Baseline materials, NIH stroke scale score, modified Rankin Scale at admission, stroke causes, time from sympton onset to enrollment were recorded.
Imaging scan were conducted at admission, within 7 days after admission.
Imaging protocols:
MRI scan protocols: T2 weighted image, T1 weighted image, Diffusion weighted image(DWI), fluid-attenuated inversion recovery(FLAIR), Perfusion weighted image(PWI), arterial spin labeling(ASL) , susceptibility-weighted imaging(SWI).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Cerebral ischemic sympton with onset in 24 hours
- •pre mRS<2
- •All MR examination performed according to study protocol
- •Signed informed consent obtained from the patient or patient's legally authorized representative
- •Having complete medical history and clinical follow up
- •Imaging data can be processed
排除标准
- •Intracranial hemorrhage
- •Pregnancy and other contraindication to MRI scan
- •Informed consent not obtained
- •Pre-existing medical, neurological or psychiatric disease that would confound the neurological, functional, or imaging evaluations
- •Known allergy to iodine previously refractory to pretreatment medications
- •Renal Failure (serum creatinine > 2.0 or Glomerular Filtration Rate [GFR] < 30)
- •History of sever kidney disease as an adult, including tumor or transplant surgery, or family history of kidney failure
- •Severe cardiac insufficiency
结局指标
主要结局
modified Rankin Score
时间窗: Three months
Modified Rankin Score of patients with acute stroke after 3 months will be followed up for neurological outcome assessment. mRS \< 2 is defined as favorable
次要结局
- Final infarct volume(Seven days to 1 month)
- Stroke event(within 1 year)
- mortality(within 1 year)
研究者
Xin Lou
Deputy Chief of Radiology
Chinese PLA General Hospital