Brain Aneurysm
Conditions
Brief summary
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
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).
Interventions
PROCEDURESurgical Clipping of Aneurysm
Surgical clipping of intracranial aneurysm
Sponsors
Albany Medical College
Northwestern University
Stony Brook University
Royal University Hospital Foundation
Indiana University
Providence Health & Services
University of Illinois at Chicago
Vanderbilt University
Methodist Health System
Medical University of South Carolina
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Histological Change | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment related morbidity and mortality | up to approximately 1 year post treatment | Secondary analyses will be performed to compare treatment related morbidity and mortality, |
| 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 | 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 |
| Bleeding Rate | post treatment during approximate follow up periods 6mo and 12mo clinical follow up | bleeding rate post treatment. |
Countries
Canada, United States
Outcome results
None listed