Biomarkers for Initiating Onsite and Faster Ambulance Stroke Therapies (BIO-FAST)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 176
- 试验地点
- 4
- 主要终点
- Times to reperfusion
研究概览
简要总结
Stroke is the first cause of death among Spanish women and main cause of disability. Reperfusion therapies of the occluded artery remain the only useful approach in acute ischemic stroke. However, the efficacy of these strategies is highly time-dependent and due to the need of neuroimaging (CT or MRI) to differentiate between ischemic and hemorrhagic stroke, impossible to be performed at the pre-hospital level. The investigators aim to set-up a point of-care (POC) device to validate a biomarker panel differentiating ischemic and hemorrhagic stroke at the pre-hospital level using a blood sample and to validate a second biomarker panel for the early identification of patients with large vessel occlusions (LVO), which are candidates for mechanical thrombectomy. For that, the investigators will recruit a 300 patients' cohort with pre-hospital blood samples using available POCs for each of those markers.
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
- •I.1: Patients > 18 years old.
- •I.2: Stroke code activated by the coordinator centre.
- •I.3: < 6 hours from symptoms onset. In the case of stroke with uncertain chronology or wake-up stroke, the initial time will be considered as the last moment the patient was seen fine.
排除标准
- •E.1: Prehospital diagnosis different of stroke.
- •E.2: Impossibility of getting a prehospital blood sample.
- •E.3: Refusal to provide the informed consent by the patient/relative.
结局指标
主要结局
Times to reperfusion
时间窗: through study completion, an average of 2 years
Stroke subtype diagnostic accuracy
时间窗: through study completion, an average of 2 years
Stroke subtype diagnostic (% ischemic versus % hemorrhagic and % stroke mimics) will be determined by clinical and neuroimaging criteria at hospital arrival and compared with diagnostic accuracy of a blood biomarkers based test
Reperfusion rates
时间窗: through study completion, an average of 2 years
次要结局
未报告次要终点
研究者
Joan Montaner Villalonga
Head Department of Neurology
Hospital Universitario Virgen Macarena
