Aneurysm Wall Histology Registry
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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Aneurysm Wall Histology and Correlation With Cerebrospinal Fluid and Blood Plasma Registry|
- Histological Change [ Time Frame: an average of 1 day after aneurysm treatment an analysis of the histological sample, CSF sample, and plasma samples will occur ] [ Designated as safety issue: No ]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.
- Treatment related morbidity and mortality [ Time Frame: up to approximately 1 year post treatment ] [ Designated as safety issue: Yes ]Secondary analyses will be performed to compare treatment related morbidity and mortality,
- Clinical Outcome [ Time Frame: 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 ] [ Designated as safety issue: No ]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 [ Time Frame: post treatment during approximate follow up periods 6mo and 12mo clinical follow up ] [ Designated as safety issue: Yes ]bleeding rate post treatment.
|Study Start Date:||June 2010|
|Estimated Study Completion Date:||June 2015|
|Estimated Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
Procedure: Surgical Clipping of Aneurysm
Surgical clipping of intracranial aneurysm
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).
|United States, Florida|
|University of Florida Hospital|
|Gainesville, Florida, United States, 32610-0261|
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|United States, New York|
|Albany Medical Center|
|Albany, New York, United States, 12208-3412|
|SUNY - Stonybrook University Medical Center|
|Stonybrook, New York, United States, 11794|
|United States, South Carolina|
|Medical University of South Carolina|
|Charleston, South Carolina, United States, 29401|
|United States, Tennessee|
|Baptist Hospital - Collerville|
|Collierville, Tennessee, United States, 38120|
|Royal University Hospital|
|Saskatoon, Ontario, Canada, S7N OW8|
|Principal Investigator:||Alan Boulos, MD||Albany Medical College|
|Principal Investigator:||Bernard Bendok||Northwestern University|
|Principal Investigator:||Henry Woo||SUNY - Stonybrook|
|Principal Investigator:||Arthur Adam, MD||Baptist Hospital|
|Principal Investigator:||J. Mocco||University of Florida Hospital|
|Principal Investigator:||Mike Kelly||Royal University Hospital Foundation|