Brain Aneurysm Clinical Trial
Official title:
Aneurysm Wall Histology and Correlation With Cerebrospinal Fluid and Blood Plasma 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.
Status | Completed |
Enrollment | 24 |
Est. completion date | June 2015 |
Est. primary completion date | June 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
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 |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Royal University Hospital | Saskatoon | Ontario |
United States | Albany Medical Center | Albany | New York |
United States | Medical University of South Carolina | Charleston | South Carolina |
United States | Northwestern University | Chicago | Illinois |
United States | University Of Illinois | Chicago | Illinois |
United States | Goodman Campbell | Indianapolis | Indiana |
United States | Methodist Healthcare - Memphis | Memphis | Tennessee |
United States | Vanderbilt University | Nashville | Tennessee |
United States | Providence Health | Portland | Oregon |
United States | SUNY - Stonybrook University Medical Center | Stonybrook | New York |
Lead Sponsor | Collaborator |
---|---|
Medical University of South Carolina | Albany Medical College, Indiana University, Methodist Health System, Northwestern University, Providence Health & Services, Royal University Hospital Foundation, Stony Brook University, University of Illinois at Chicago, Vanderbilt University |
United States, Canada,
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* Note: There are 35 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | Treatment related morbidity and mortality | Secondary analyses will be performed to compare treatment related morbidity and mortality, | up to approximately 1 year post treatment | Yes |
Secondary | 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 | No |
Secondary | Bleeding Rate | bleeding rate post treatment. | post treatment during approximate follow up periods 6mo and 12mo clinical follow up | Yes |
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