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Aneurysm Wall Histology Registry

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01444664
First Posted: October 3, 2011
Last Update Posted: March 24, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Albany Medical College
Northwestern University
Stony Brook University
Royal University Hospital Foundation
Indiana University
Providence Health & Services
University of Illinois at Chicago
Vanderbilt University
Methodist Health System
Information provided by (Responsible Party):
Medical University of South Carolina
  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: None (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 ]
    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 ]
    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 ]
    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 ]
    bleeding rate post treatment.


Enrollment: 24
Study Start Date: June 2010
Study Completion Date: June 2015
Primary Completion Date: June 2015 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01444664


Locations
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
University Of Illinois
Chicago, Illinois, United States, 60612
United States, Indiana
Goodman Campbell
Indianapolis, Indiana, United States, 46202
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, Oregon
Providence Health
Portland, Oregon, United States, 97225
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29401
United States, Tennessee
Methodist Healthcare - Memphis
Memphis, Tennessee, United States, 38104
Vanderbilt University
Nashville, Tennessee, United States, 37240
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
Royal University Hospital Foundation
Indiana University
Providence Health & Services
University of Illinois at Chicago
Vanderbilt University
Methodist Health System
Investigators
Principal Investigator: Henry Woo SUNY - Stonybrook
Principal Investigator: Arthur Adam, MD Baptist 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
First Submitted: August 30, 2011
First Posted: October 3, 2011
Last Update Posted: March 24, 2016
Last Verified: April 2015

Additional relevant MeSH terms:
Aneurysm
Intracranial Aneurysm
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases