Aneurysm Wall Histology and Correlation With Cerebrospinal Fluid and Blood Plasma Registry
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 20
- 主要终点
- Histological Change
研究概览
简要总结
The purpose of this prospective registry is to determine if patients harboring intracranial aneurysms have any predictive markers between aneurysm wall tissue, cerebrospinal fluid and blood plasma.
详细描述
To design a registry to evaluate the wall of intracranial aneurysms during open surgical clipping by direct photographic appearance, wall biopsy samples, CSF and blood plasma fluid collection (Interleukins; IL-8/ Matrix Metalloproteinase; MMP-9) for complete evaluation and comparison.
The focus of the registry will be to determine the presence of aneurysmal wall defects, mural clot, atherosclerotic and atheroma, wall permeability and delamination. These findings will then be correlated to the collected CSF and blood values to determine if there is any direct features of the aneurysm wall that would predict any of the reported post embolic syndromes. The collected data can also be correlated to the peroperative imaging, (MRI, CT and Angiogram).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient > 18 years but < 80 years of age
- •Patient with an unruptured Intracranial aneurysm 8mm or larger
- •Patient that surgical exposure and clipping will be the primary treatment option
排除标准
- •Any patient that has a ruptured intracranial aneurysm
- •Any Pediatric patients
- •Any patient presenting with any pre-treatment intracranial lesions
- •Vascular malformations
- •Hemorrhage
- •Normal Pressure Hydrocephalus
- •Obstructive Hydrocephalus
- •White matter disease
- •Other vascular type lesions
- •Any meningitis type symptoms
- •Medical or surgical co-morbidities such that the patient's life expectancy is less than 1 year
- •Inability to obtain consent
结局指标
主要结局
Histological Change
时间窗: an average of 1 day after aneurysm treatment an analysis of the histological sample, CSF sample, and plasma samples will occur
To determine the relative and absolute differences in histological changes as seen in the tissue samples comparing this to the CSF and blood plasma samples. To also determine if there is any gene expressions that can be utilized as predictive markers in this cohort of patients.
次要结局
- Treatment related morbidity and mortality(up to approximately 1 year post treatment)
- Clinical Outcome(approximately clinical outcome at 6 months after surgical clipping at routine follow up visit and approximately 12 months after clipping at routine follow up visit if indicated)
- Bleeding Rate(post treatment during approximate follow up periods 6mo and 12mo clinical follow up)