Evaluation of the PS100B for the Diagnostic of Stroke With Patients Out of Delay for Thrombolysis or Thrombectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 179
- 试验地点
- 2
- 主要终点
- Diagnostic value of PS100B
研究概览
简要总结
Numerous patients are addressed to the Emergency Department for unspecific symptoms which can evoke a stroke, such as vertigo, isolated motor deficit, behavior disorder.
For these patients, when they arrive out of time for specific treatments such as thrombolysis and thrombectomy, the cerebral imagery is not an emergency, but necessary to confirm or invalidate the diagnostic of stroke.
If a biomarker could exclude the diagnostic of stroke, we could avoid an imagery for these patients.
PS100B is a biomarker whose blood level increases in case of stroke. It has already proven a prognostic value. Until now, it hasn't proven a diagnostic value because it take a few hours to increase in the blood.
It could have in prognostic value for patients who have the symptoms for more than 24 hours.
STROkE is a diagnostic, prospective, monocentric study, conducted at University Hospital Center of Poitiers (France).
The aim is to determine the value of PS100B to exclude the diagnostic of a stroke in case of evocative symptoms, for patients who are out of delay for a thrombolysis or a thrombectomy.
Patients eligible are the ones who present to the emergency department with symptoms evocative of stroke for more than 24 hours and less than 4 days. Patients included have a sample of blood withdrawn, in order to measure PS100B blood level.
The diagnostic of stroke is than confirmed or excluded by an adjudication comity, who are unaware of the result of PS100B blood level.
The diagnostic value of PS100B is determined with the help of a ROC curve.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients presenting at the Emergency Department of the University Hospital Center of Poitiers for the following symptoms, which last since more then 24 hours et less then 4 days :
- •sensitive or motor deficit of one or several limbs
- •facial paralysis
- •impairment of speech
- •dysarthria
- •impairment of vision
- •oculomotor disorder
- •free patient, without guardianship or curatorship, or subordination
- •patient not objecting to research
排除标准
- •head trauma that occured less then 15 days ago
- •known cerebral mass or melanoma
- •refusal to participate in research
- •patient benefiting from enhanced protection, namely: minors, persons deprived of their liberty by a judicial or administrative decision, adults under legal protection
- •pregnant and/or breastfeeding women
结局指标
主要结局
Diagnostic value of PS100B
时间窗: 1 day
Determine the best couple sensibility / specificity of the blood value of PS100B with the help of a Receive Operating Charasteristics (ROC) curve for patients who present with symptoms evocative of stroke since more than 24 hours and less than 4 days
次要结局
- Value of PS100B and time delay since the beginning of the symptoms(1 day)
- Prognostic value of PS100B(28 days)
- Value of PS100B for ischemic strokes and hemorrhagic strokes(1 day)