Aneurysm Wall Histology Registry

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Albany Medical College
Northwestern University
Stony Brook University
Baptist Memorial Health Care Corporation
University of Florida
Royal University Hospital Foundation
Information provided by (Responsible Party):
Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT01444664
First received: August 30, 2011
Last updated: October 16, 2013
Last verified: September 2011

August 30, 2011
October 16, 2013
June 2010
June 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01444664 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Aneurysm Wall Histology Registry
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.

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).

Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Brain Aneurysm
Procedure: Surgical Clipping of Aneurysm
Surgical clipping of intracranial aneurysm
Experimental: Aneurysm
Intervention: Procedure: Surgical Clipping of Aneurysm

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
50
June 2015
June 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT01444664
20137
No
Medical University of South Carolina
Medical University of South Carolina
  • Albany Medical College
  • Northwestern University
  • Stony Brook University
  • Baptist Memorial Health Care Corporation
  • University of Florida
  • Royal University Hospital Foundation
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
Medical University of South Carolina
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP