Biomarkers algOrithm for strOke diagnoSis and Treatment Resistance Prediction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,880
- 试验地点
- 4
- 主要终点
- Diagnosis by the selected panel of blood biomarkers of the LVO presence eligible for MT
研究概览
简要总结
Triage of acute ischemic stroke (AIS) patients is critical, to decrease time to treatment, and improve functional outcome. The therapeutic standard of care for AIS consecutive to large vessel occlusion (LVO) is the association of intravenous (IV) alteplase administration and mechanical thrombectomy (MT). However, there are limited places where MT can be performed. Therefore, there is a need for innovative tools to identify, in the ambulance, patients with LVO that require MT. Sending the patients at the right, avoiding futile stops (i.e. in places where MT is not available), is definitively a strategy that saves time.
There is currently no biomarker nor Point Of Care (POC) Lab Testing to solve this issue and clinical scoring methods such as the NIHSS have a low accuracy rate to detect LVO. The relevance of blood biomarkers for LVO diagnosis and therapeutic decisions needs to be confirmed for effective triage in the setting of AIS with LVO, which represent 30% of all AIS.
The main objective of our study is to determine diagnostic performances of a panel of selected blood biomarkers to identify patients with AIS consecutive to LVO among those with stroke suspicion, within 24 hours of stroke symptom's onset before brain imaging.
This could facilitate the triage of patients with LVO refractory to thrombolysis treatment, who may benefit most from MT.
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
- •Symptoms consistent with stroke <24 hours
- •Adult patients ≥ 18 years old
- •Non opposition of the patient or his/her relatives to the research (emergency inclusion procedure)
排除标准
- •Patient under guardianship or curatorship
结局指标
主要结局
Diagnosis by the selected panel of blood biomarkers of the LVO presence eligible for MT
时间窗: within 24 hours following inclusion
次要结局
- Discrimination by the selected panel of blood biomarkers of LVO from small strokes, and AIS from hemorrhagic strokes and stroke mimics(within 24 hours following inclusion)
- Functional outcome(at day 90 after inclusion)
- Early neurological improvement(at day 1 after inclusion)
- reperfusion therapy resistance (i.e. IV thrombolysis, MT)(within 24 hours following inclusion)
- cardio-embolic origin(at 3 months)