PREdictive Value of FLAIR and DWI for the Identification of Acute Ischemic Stroke Patients ≤ 3 and ≤ 4.5 h of Symptom Onset - a Multicenter Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 643
- 试验地点
- 2
- 主要终点
- Specificity (and 95% CI) of "DWI-FLAIR-mismatch" for the identification of patients ≤3 and ≤4.5 hours
研究概览
简要总结
The aim of the study is to evaluate the use of combined fluid attenuated inversion recovery (FLAIR) imaging and diffusion weighted imaging (DWI) as surrogate marker of lesion age within the first 6 hours of ischemic stroke in order to identify patients ≤ 3 or ≤ 4.5 hours of symptom onset in a large multicenter study hours of ischemic stroke. The investigators hypothesize that the pattern of a visible lesion on DWI together with a negative FLAIR ("DWI-FLAIR mismatch") will identify patients ≤ 3 hours of symptom onset with >80% specificity and positive predictive value.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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
- •Acute ischemic stroke (proven by initial or follow-up MRI)
- •Well defined and known symptom onset
- •Stroke MRI including diffusion weighted imaging (DWI) and fluid attenuated inversion recovery (FLAIR) sequences performed within 12 hours of symptom onset
- •Informed consent
排除标准
- •Contraindications against MRI
结局指标
主要结局
Specificity (and 95% CI) of "DWI-FLAIR-mismatch" for the identification of patients ≤3 and ≤4.5 hours
时间窗: on admission
次要结局
- Predictors of a "negative FLAIR" in acute ischemic stroke(on admission)
研究者
Götz Thomalla, MD
PD Dr. med. Götz Thomalla
Universitätsklinikum Hamburg-Eppendorf