Amyloid Imaging and Cognitive Impairment After Intracerebral Hemorrhage
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Pet-AV45 cortical binding
研究概览
简要总结
To evaluate Pet AV-45 Amyloid imaging in the etiological diagnosis of primary non traumatic intracerebral hemorrhage (Cerebral Amyloid Angiopathy and hypertension related hemorrhage).We hypothesize that patients with lobar hemorrhage (probably related to Cerebral Amyloid Angiopathy) will have a greater AV45 cortical binding than patients with deep hemorrhage (probably related to hypertension).
详细描述
Cerebral Amyloid Angiopathy (CAA) and hypertension related hemorrhage are the main causes of non traumatic primary intracerebral hemorrhage. In vivo diagnosis of these two cerebral diseases may be difficult and is based on hematoma location and pattern of cerebral microbleeds (CMB) distribution. We aimed to evaluate a multimodal approach including brain MRI, Pet AV-45 Amyloid imaging and neuropsychological assessment to improve etiological diagnosis of primary intracerebral hemorrhage. 70 patients with acute primary non traumatic intracerebral hemorrhage will be prospectively included and two groups will be compared: lobar hemorrhage group and deep hemorrhage group. Brain MRI, Pet AV-45 Cerebral Amyloid imaging (during the first month) and neuropsychological assessment (Three months later) are performed. Differences between the two groups are evaluated for AV45 cortical binding, CMB distribution, White Matter Lesions and cognitive profile.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age : 40-90 years,
- •Non traumatic primary intracerebral hemorrhage during acute phase (less than 30 days from hemorrhage onset) confirmed on brain imaging (CT and/or MRI).
- •Correct visual, hearing and language functions to perform neuropsychological tests.
- •Written consent of patient
排除标准
- •Secondary causes of intracerebral hemorrhage : vascular malformations (Arteriovenous malformation, intracranial aneurysm, Cavernous angioma, dural arteriovenous fistula), cerebral venous thrombosis, intracranial neoplasm, coagulopathy, vascularitis, Cocaine or alcohol use, Hemorrhagic ischemic stroke.
- •Pregnancy
- •Contraindication to MRI
- •progressive neoplasm
- •Cognitive impairment secondary to progressive neurological disease
- •Depression,
- •Drug addiction
研究组 & 干预措施
lobar hemorrhage group
PET AV-45 in patients with cortical or corticosubcortical hemorrhage (involving predominantly the cortex and underlying white matter)
干预措施: Pet AV-45 (Other)
deep hemorrhage group
PET AV-45patients with subcortical hemorrhage (involving predominately the basal ganglia, periventricular white matter, or internal capsule).
干预措施: Pet AV-45 (Other)
结局指标
主要结局
Pet-AV45 cortical binding
时间窗: Acute phase of intracerebral hemorrhage ie during the first month after hemorrhage onset.
Method of administration: a bolus IV injection (less than 1 minute of injection time) of 5 MBq / kg with a maximum of 370MBq. The activity corresponding to a 70 kg individual is 350 MBq and corresponds to an effective dose of 12.25mSv (0.035mSv/MBq)
次要结局
- cerebral microbleeds number and distribution on T2EG MRI sequence(Acute phase of intracerebral hemorrhage ie during the first month)
- White Matter Lesions Volume on 3D-FLAIR MRI sequence(Acute phase of intracerebral hemorrhage ie during the first month)
- Cortical thickness and hippocampal volume on 3D-T1 MRI sequence(Acute phase of intracerebral hemorrhage ie during the first month)
- Neuropsychological performances(three months after hemorrhage onset.)