Clinical trial NCT01444664: Aneurysm Wall Histology Registry
Official title: Aneurysm Wall Histology and Correlation With Cerebrospinal Fluid and Blood Plasma Registry
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Brain Aneurysm
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: Albany Medical College
name: Northwestern University
name: Stony Brook University
name: Royal University Hospital Foundation
name: Indiana University
name: Providence Health & Services
name: University of Illinois at Chicago
name: Vanderbilt University
name: Methodist Health System
First posted: 2011-10-03
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Histological Change
timeFrame: an average of 1 day after aneurysm treatment an analysis of the histological sample, CSF sample, and plasma samples will occur
Secondary outcomes:
measure: Treatment related morbidity and mortality
timeFrame: up to approximately 1 year post treatment
measure: Clinical Outcome
timeFrame: 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
measure: Bleeding Rate
timeFrame: post treatment during approximate follow up periods 6mo and 12mo clinical follow up
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Chicago
country: United States
facility: University Of Illinois
state: Illinois
city: Indianapolis
country: United States
facility: Goodman Campbell
state: Indiana
city: Albany
country: United States
facility: Albany Medical Center
state: New York
city: Stonybrook
country: United States
facility: SUNY - Stonybrook University Medical Center
state: New York
city: Portland
country: United States
facility: Providence Health
state: Oregon
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Memphis
country: United States
facility: Methodist Healthcare - Memphis
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
city: Saskatoon
country: Canada
facility: Royal University Hospital
state: Ontario
Study officials:
affiliation: SUNY - Stonybrook
name: Henry Woo
role: PRINCIPAL_INVESTIGATOR
affiliation: Baptist Hospital
name: Arthur Adam, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Royal University Hospital Foundation
name: Mike Kelly
role: PRINCIPAL_INVESTIGATOR
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