Aneurysm Wall Histology Registry
Primary Purpose
Brain Aneurysm
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Surgical Clipping of Aneurysm
Sponsored by
About this trial
This is an interventional treatment trial for Brain Aneurysm
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
Sites / Locations
- Northwestern University
- University Of Illinois
- Goodman Campbell
- Albany Medical Center
- SUNY - Stonybrook University Medical Center
- Providence Health
- Medical University of South Carolina
- Methodist Healthcare - Memphis
- Vanderbilt University
- Royal University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Aneurysm
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Treatment related morbidity and mortality
Secondary analyses will be performed to compare treatment related morbidity and mortality,
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
Bleeding Rate
bleeding rate post treatment.
Full Information
NCT ID
NCT01444664
First Posted
August 30, 2011
Last Updated
March 23, 2016
Sponsor
Medical University of South Carolina
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
1. Study Identification
Unique Protocol Identification Number
NCT01444664
Brief Title
Aneurysm Wall Histology Registry
Official Title
Aneurysm Wall Histology and Correlation With Cerebrospinal Fluid and Blood Plasma Registry
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of South Carolina
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
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Aneurysm
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Aneurysm
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Surgical Clipping of Aneurysm
Intervention Description
Surgical clipping of intracranial aneurysm
Primary Outcome Measure Information:
Title
Histological Change
Description
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.
Time Frame
an average of 1 day after aneurysm treatment an analysis of the histological sample, CSF sample, and plasma samples will occur
Secondary Outcome Measure Information:
Title
Treatment related morbidity and mortality
Description
Secondary analyses will be performed to compare treatment related morbidity and mortality,
Time Frame
up to approximately 1 year post treatment
Title
Clinical Outcome
Description
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
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
Title
Bleeding Rate
Description
bleeding rate post treatment.
Time Frame
post treatment during approximate follow up periods 6mo and 12mo clinical follow up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henry Woo
Organizational Affiliation
SUNY - Stonybrook
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Arthur Adam, MD
Organizational Affiliation
Baptist Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mike Kelly
Organizational Affiliation
Royal University Hospital Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
University Of Illinois
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Goodman Campbell
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Albany Medical Center
City
Albany
State/Province
New York
ZIP/Postal Code
12208-3412
Country
United States
Facility Name
SUNY - Stonybrook University Medical Center
City
Stonybrook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
Providence Health
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29401
Country
United States
Facility Name
Methodist Healthcare - Memphis
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States
Facility Name
Vanderbilt University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37240
Country
United States
Facility Name
Royal University Hospital
City
Saskatoon
State/Province
Ontario
ZIP/Postal Code
S7N OW8
Country
Canada
12. IPD Sharing Statement
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Aneurysm Wall Histology Registry
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