COrtical Superficial Siderosis and REcurrent Lobar Intracerebral Hemorrhage in Cerebral Amyloid Angiopathy.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 170
- 试验地点
- 5
- 主要终点
- Recurrent symptomatic intracerebral hemorrhage at 24 months
研究概览
简要总结
Cerebral amyloid angiopathy (CAA) is a major cause of lobar intracerebral hemorrhage (ICH) in the elderly with high risk of recurrence.
The investigators aim to determine the relationship between cortical superficial siderosis (cSS), a MRI hemorrhagic marker of CAA and the risk of symptomatic ICH recurrence in a multicentric prospective cohort of patients with acute lobar ICH related to CAA. The investigators hypothesize that patients with cSS have an increased risk of recurrent symptomatic ICH relative to those without cSS.
详细描述
Patients with acute lobar ICH fulfilling the Boston criteria for probable or possible CAA will be enrolled within 30 days after ICH onset. Brain MRI performed at baseline will be analyzed blinded to clinical data. Patients with presence of cSS will be compared with those without cSS.
During a systematic follow-up of 24 months, patients will undergo neurological, neuropsychological and MRI evaluation. The investigators will compare the rate of recurrent symptomatic ICH at 24 months in patients with vs. without cSS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Lobar ICH within 30 days after onset
- •Available brain MRI sequences of adequate quality including fluid-attenuated inversion recovery (FLAIR) and T2*-weighted gradient-recalled echo (T2*-GRE) sequences.
- •Modified Boston criteria for probable or possible CAA
- •Age ≥ 55 years
- •Written consent
排除标准
- •Secondary brain hemorrhage : vascular malformation (arteriovenous malformation, aneurysm, cavernous); cerebral veinous thrombosis; brain tumor; coagulopathy; vasculitis; hemorrhagic infarction,
- •Infratentorial siderosis
- •Contraindications to MRI
- •Neurosurgical intervention before inclusion,
- •Progressive neoplasm
- •Patient without affiliation to the french social security
- •Patient under guardianship
结局指标
主要结局
Recurrent symptomatic intracerebral hemorrhage at 24 months
时间窗: 24 months
Recurrent symptomatic intracerebral haemorrhage is defined as a further intracerebral hemorrhage documented by CT scan or MRI, associated with new neurologic symptoms
次要结局
- New MRI hemorrhagic lesion at 12 months(12 months)
- Recurrent symptomatic ICH at 12 months(12 months)
- mortality or dependance at 12 and 24 months(12 and 24 months)
- Cognitive decline at 12 and 24 months(12 and 24 months)
- Transient Focal Neurological Episodes (TFNE) at 12 and 24 months(12 and 24 months)
- Extent of cortical superficial siderosis at 12 months(12 months)
- frequency of APOE ε2 and ε4 allele(baseline)