Helsinki Ultra-acute Stroke Biomarker Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,046
- 试验地点
- 1
- 主要终点
- Diagnostic accuracy of biomarkers for identifying ischemic stroke, transient ischemic attack, intracerebral hemorrhage and stroke mimics.
研究概览
简要总结
The aim of this study is to establish diagnostic and predictive biomarkers for patients with suspected acute stroke, that are transported by EMS as candidates for thrombolytic treatment. The study focuses on the ultra acute phase, <4.5 hours from symptom onset, including the prehospital setting. Analyses will include known biomarkers (e.g. GFAP, NR2 peptide) and a discovery phase for novel markers. Patient outcome will be evaluated at 3 month using the modified Rankin Scale (mRS).
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
- •Acute stroke suspected by EMS personnel
- •Transport to tertiary hospital as possible candidate for thrombolytic treatment of ischemic stroke
- •Successful prehospital blood sampling by EMS personnel
排除标准
- •Unsuccessful prehospital blood sampling by EMS personnel
结局指标
主要结局
Diagnostic accuracy of biomarkers for identifying ischemic stroke, transient ischemic attack, intracerebral hemorrhage and stroke mimics.
时间窗: 90 days +/- 5 days
Metrics: Receiver operating characteristic curve analysis, sensitivity, specificity, positive predictive value, negative predictive value
Predictive accuracy of biomarkers for identifying patients not responding to thrombolytic treatment.
时间窗: 90 days +/- 5 days
Metrics: Receiver operating characteristic curve analysis, sensitivity, specificity, positive predictive value, negative predictive value
Predictive accuracy of biomarkers for identifying patients facing hemorrhagic complications of thrombolytic treatment
时间窗: 90 days +/- 5 days
Metrics: Receiver operating characteristic curve analysis, sensitivity, specificity, positive predictive value, negative predictive value
Predictive accuracy of biomarkers for predicting outcome
时间窗: 90 days +/- 5 days
Metrics: Receiver operating characteristic curve analysis, sensitivity, specificity, positive predictive value, negative predictive value
次要结局
未报告次要终点
研究者
Perttu Lindsberg
Professor
Helsinki University Central Hospital