Aneurysm Wall Histology Registry

Brain Aneurysm Clinical Trial

Official title:

Aneurysm Wall Histology and Correlation With Cerebrospinal Fluid and Blood Plasma Registry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01444664
• Other study ID #: 20137
• Status: Completed
• Phase: Phase 4
• First received: August 30, 2011
• Last updated: March 23, 2016
• Start date: June 2010
• Est. completion date: June 2015

Study information

• Verified date: April 2015
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aneurysm
• Brain Aneurysm

Intervention

Procedure:
• Surgical Clipping of Aneurysm
Surgical clipping of intracranial aneurysm

Locations

Country	Name	City	State
Canada	Royal University Hospital	Saskatoon	Ontario
United States	Albany Medical Center	Albany	New York
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Northwestern University	Chicago	Illinois
United States	University Of Illinois	Chicago	Illinois
United States	Goodman Campbell	Indianapolis	Indiana
United States	Methodist Healthcare - Memphis	Memphis	Tennessee
United States	Vanderbilt University	Nashville	Tennessee
United States	Providence Health	Portland	Oregon
United States	SUNY - Stonybrook University Medical Center	Stonybrook	New York

Sponsors (10)

Lead Sponsor	Collaborator
Medical University of South Carolina	Albany Medical College, Indiana University, Methodist Health System, Northwestern University, Providence Health & Services, Royal University Hospital Foundation, Stony Brook University, University of Illinois at Chicago, Vanderbilt University

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (35)

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* Note: There are 35 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	an average of 1 day after aneurysm treatment an analysis of the histological sample, CSF sample, and plasma samples will occur	No
Secondary	Treatment related morbidity and mortality	Secondary analyses will be performed to compare treatment related morbidity and mortality,	up to approximately 1 year post treatment	Yes
Secondary	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	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	No
Secondary	Bleeding Rate	bleeding rate post treatment.	post treatment during approximate follow up periods 6mo and 12mo clinical follow up	Yes