CoHort of Patients to Identify Biological and Imaging markerS of CardiovascUlar Outcomes in Stroke.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Degree of disability (mRS Score)
研究概览
简要总结
Ischemic stroke is the first cause of acquired disability of the adult, the second cause of dementia and the third cause of death in the industrialized countries, what constitutes à major public health issue. Stroke is characterized by a cerebral parenchymal lesion due to an ischemic mechanism (85% of the cases) or hemorrhagic mechanism (15%). For a long time, the only approved treatment was the intravenous thrombolysis (rt-PA). Recently, thrombectomy has proven its superiority in this pathology.
Cohorts of patients with stroke are rare but can be very valuable by their clinical, laboratory and imaging well documented. They are the source of new hypotheses for research or interventions as well as the quality of care assessment tool.
The main objective of this project is to identify new markers: biological and imaging, treatment response and prognosis after ischemic stroke.
Secondary objectives of the HIBISCUS-STROKE cohort are to establish a clinical database, completed by biological samples and by imaging data that can be used in the following areas:
- Descriptive epidemiology of ischemic stroke and cerebral reperfusion,
- Pharmacoepidemiology and treatments observatory: safety, efficacy, indication of treatment in real life, costs
- Assessment of the long-term effect of the treatment on the occurrence of disability, stroke recurrence and death,
- Quality of life and personal, familial, professional and social consequences of stroke,
- Research of new diagnostic and prognostic biomarkers,
- Research projects.
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
- •Age> 18 years
- •Ischemic Stroke confirmed by MRI
- •Proximal arterial occlusion (ICA or M1)
- •Eligible for thrombolysis and/or thrombectomy
排除标准
- •Patients residing> 50 km from the Pierre Wertheimer Hospital (Lyon, France)
- •Inability to perform the first sample (H0)
- •Patient with progressive or uncontrolled cancer.
- •Refusal to participate in the study or to sign the consent
- •Lack of medical social coverage
- •Deprivation of civil rights
结局指标
主要结局
Degree of disability (mRS Score)
时间窗: 5 years
Degree of disability: modified Rankin Score
次要结局
- infarct size(day 6)
- Hemorrhagic transformation(24 hours)
- Neurological deficit(up to 5 years)
- Quality of life(up to 5 years)