Amyloid Imaging and Cognitive Impairment After Intracerebral Hemorrhage (COGHIC-AV45)
2018年9月20日 更新者：University Hospital, Toulouse
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).
研究概览
详细说明
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.
研究类型
介入性
注册 (实际的)
70
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Toulouse、法国、31059
- Service de Neurologie
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
40年 至 90年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：基础科学
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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其他：lobar hemorrhage group
PET AV-45 in patients with cortical or corticosubcortical hemorrhage (involving predominantly the cortex and underlying white matter)
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AV-45 (Florbetapir F 18) : Bolus of 5 MBq/kg IV ; A 10-minutes Pet scan acquisition Starts at 50 minutes after injection.
其他名称：
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其他：deep hemorrhage group
PET AV-45patients with subcortical hemorrhage (involving predominately the basal ganglia, periventricular white matter, or internal capsule).
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AV-45 (Florbetapir F 18) : Bolus of 5 MBq/kg IV ; A 10-minutes Pet scan acquisition Starts at 50 minutes after injection.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Pet-AV45 cortical binding
大体时间：Acute phase of intracerebral hemorrhage ie during the first month after hemorrhage onset.
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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)
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Acute phase of intracerebral hemorrhage ie during the first month after hemorrhage onset.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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cerebral microbleeds number and distribution on T2EG MRI sequence
大体时间：Acute phase of intracerebral hemorrhage ie during the first month
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Review safe after checking against usual contraindications (pacemaker, ocular foreign body), painless, lasting about 45 minutes, during which a detailed analysis of the brain will be performed
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Acute phase of intracerebral hemorrhage ie during the first month
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White Matter Lesions Volume on 3D-FLAIR MRI sequence
大体时间：Acute phase of intracerebral hemorrhage ie during the first month
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Review safe after checking against usual contraindications (pacemaker, ocular foreign body), painless, lasting about 45 minutes, during which a detailed analysis of the brain will be performed
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Acute phase of intracerebral hemorrhage ie during the first month
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Cortical thickness and hippocampal volume on 3D-T1 MRI sequence
大体时间：Acute phase of intracerebral hemorrhage ie during the first month
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Review safe after checking against usual contraindications (pacemaker, ocular foreign body), painless, lasting about 45 minutes, during which a detailed analysis of the brain will be performed
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Acute phase of intracerebral hemorrhage ie during the first month
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Neuropsychological performances
大体时间：three months after hemorrhage onset.
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a neuropsychological examination (tests of memory, language and attention) will be realized.
This examination will last approximately 60 minutes and take place in consultation with neurology
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three months after hemorrhage onset.
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Nicolas RAPOSO, MD、University Hospital, Toulouse
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Planton M, Pariente J, Nemmi F, Albucher JF, Calviere L, Viguier A, Olivot JM, Salabert AS, Payoux P, Peran P, Raposo N. Interhemispheric distribution of amyloid and small vessel disease burden in cerebral amyloid angiopathy-related intracerebral hemorrhage. Eur J Neurol. 2020 Aug;27(8):1664-1671. doi: 10.1111/ene.14301. Epub 2020 May 31.
- Planton M, Saint-Aubert L, Raposo N, Branchu L, Lyoubi A, Bonneville F, Albucher JF, Olivot JM, Peran P, Pariente J. High prevalence of cognitive impairment after intracerebral hemorrhage. PLoS One. 2017 Jun 1;12(6):e0178886. doi: 10.1371/journal.pone.0178886. eCollection 2017.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2012年1月1日
初级完成 (实际的)
2017年6月1日
研究完成 (实际的)
2017年6月1日
研究注册日期
首次提交
2012年6月12日
首先提交符合 QC 标准的
2012年6月12日
首次发布 (估计)
2012年6月14日
研究记录更新
最后更新发布 (实际的)
2018年9月21日
上次提交的符合 QC 标准的更新
2018年9月20日
最后验证
2018年9月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
脑出血的临床试验
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Wake Forest University Health Sciences主动，不招人
Pet AV-45的临床试验
-
University Hospital, Tours完全的
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Chang Gung Memorial Hospital未知
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Avid RadiopharmaceuticalsEli Lilly and Company完全的
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Eli Lilly and Company完全的