Aneurysm Wall Histology Registry

Medical University of South Carolina24 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Brain Aneurysm

Interventions

Surgical Clipping of AneurysmPROCEDURE

Surgical clipping of intracranial aneurysm

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (10)

Northwestern University

Chicago, Illinois, United States

University Of Illinois

Chicago, Illinois, United States

Goodman Campbell

Indianapolis, Indiana, United States

Outcomes

Primary Outcomes

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.

Time frame: an average of 1 day after aneurysm treatment an analysis of the histological sample, CSF sample, and plasma samples will occur

Secondary Outcomes

Treatment related morbidity and mortality

Secondary analyses will be performed to compare treatment related morbidity and mortality,

Time frame: up to approximately 1 year post treatment

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

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

Bleeding Rate

bleeding rate post treatment.

Time frame: post treatment during approximate follow up periods 6mo and 12mo clinical follow up

Data from ClinicalTrials.gov

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