Aneurysm Wall Histology Registry

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Aneurysm Wall Histology and Correlation With Cerebrospinal Fluid and Blood Plasma Registry

Conditions
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Brain Aneurysm

Intervention / Treatment
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* Procedure: Surgical Clipping of Aneurysm


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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 Tumors Trauma 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aneurysm<br> | Procedure: Surgical Clipping of Aneurysm<br>* Surgical clipping of intracranial aneurysm<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Histological Change | 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. | an average of 1 day after aneurysm treatment an analysis of the histological sample, CSF sample, and plasma samples will occur | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment related morbidity and mortality | Secondary analyses will be performed to compare treatment related morbidity and mortality, | up to approximately 1 year post treatment | 
| Clinical Outcome | clinical outcome at approximately 6 months after surgical clipping at routine follow up visit and approximately 12 months after clipping at routine follow up visit if indicated | 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 | bleeding rate post treatment. | post treatment during approximate follow up periods 6mo and 12mo clinical follow up |