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
  Purpose

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.


Condition Intervention Phase
Brain Aneurysm
Procedure: Surgical Clipping of Aneurysm
Phase 4

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 50
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)
Arms Assigned Interventions
Experimental: Aneurysm Procedure: Surgical Clipping of Aneurysm
Surgical clipping of intracranial aneurysm

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01444664

Locations
United States, Florida
University of Florida Hospital
Gainesville, Florida, United States, 32610-0261
United States, Illinois
Northwestern University
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
Canada, Ontario
Royal University Hospital
Saskatoon, Ontario, Canada, S7N OW8
Sponsors and Collaborators
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
Investigators
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
  More Information

Publications:

Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT01444664     History of Changes
Other Study ID Numbers: 20137
Study First Received: August 30, 2011
Last Updated: October 16, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Aneurysm
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014