Immuno-inflammatory Profile and Response to Ischemic Stroke Reperfusion Therapies
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 300
- 主要终点
- Immuno-inflammatory profile description in patients with ischemic stroke and eligible for reperfusion treatment
研究概览
简要总结
IMMUNOSTROKE study aims to describe the immuno-inflammatory and thrombo-inflammatory profiles during the course of AIC management by reperfusion treatment and to monitor changes in these different parameters over time. Post-hoc analyses will make it possible to correlate the immuno-inflammatory and thrombo-inflammatory profiles and their evolution with the clinical outcome in terms of post-AIC functional and cognitive disability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient over 18 years of age
- •Presenting with an ACS for which reperfusion therapy is indicated according to European and North American recommendations (IV thrombolysis or mechanical thrombectomy or a combination of both)
- •Having received informed information about the study and having signed a consent form to participate in the study (if this is not possible: information and consent from a trusted person or family member if present; emergency inclusion if absent)
- •Affiliated with or beneficiary of a social security system
排除标准
- •Contraindication to performing a brain MRI (claustrophobia, pacemaker, or other implantable device contraindicating the performance of an MRI)
- •Intracranial hemorrhage associated with AIC on initial imaging
- •Immunosuppressive treatment or corticosteroid therapy at patient admission
- •Pre-existing neurological disability limiting neurological assessment at 3 months (mRS>2 at admission)
- •Known and diagnosed dementia pre-existing at the time of the AIC
- •Absolute or relative contraindication to the injection of gadolinium (history of true allergic reaction or intolerance to gadobutrol, renal failure with creatinine clearance <15mL/min, pregnant or breastfeeding women)
- •Patient treated by another institution and referred solely for mechanical thrombectomy
- •Patient benefiting from legal protection measures
结局指标
主要结局
Immuno-inflammatory profile description in patients with ischemic stroke and eligible for reperfusion treatment
时间窗: Up to year
Patients will be evaluated for inflammatory biomarkers at inclusion, at 24-48 hours of reperfusion treatment , at 72 hours, at 7 days or at discharge if before D7, at discharge if after D7, at 3 months and at 1 year.The biomarkers will be measured using ELISA preconfigurated panels for inflammatory biomarkers.
次要结局
未报告次要终点