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临床试验/NCT04612218
NCT04612218已完成不适用

Biomarkers for Initiating Onsite and Faster Ambulance Stroke Therapies (BIO-FAST)

Hospital Universitario Virgen Macarena4 个研究点 分布在 1 个国家目标入组 176 人开始时间: 2019年11月8日最近更新:
适应症

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

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

发起方
Hospital Universitario Virgen Macarena
申办方类型
Other
责任方
Principal Investigator
主要研究者

Joan Montaner Villalonga

Head Department of Neurology

Hospital Universitario Virgen Macarena

研究点 (4)

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