Aneurysm Wall Histology Registry

March 23, 2016 updated by: Medical University of South Carolina

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Saskatoon, Ontario, Canada, S7N OW8
        • Royal University Hospital
  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University
      • Chicago, Illinois, United States, 60612
        • University of Illinois
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Goodman Campbell
    • New York
      • Albany, New York, United States, 12208-3412
        • Albany Medical Center
      • Stonybrook, New York, United States, 11794
        • SUNY - Stonybrook University Medical Center
    • Oregon
      • Portland, Oregon, United States, 97225
        • Providence Health
    • South Carolina
      • Charleston, South Carolina, United States, 29401
        • Medical University of South Carolina
    • Tennessee
      • Memphis, Tennessee, United States, 38104
        • Methodist Healthcare - Memphis
      • Nashville, Tennessee, United States, 37240
        • Vanderbilt University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Aneurysm
Procedure: Surgical Clipping of Aneurysm
Surgical clipping of intracranial aneurysm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
an average of 1 day after aneurysm treatment an analysis of the histological sample, CSF sample, and plasma samples will occur

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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,
up to approximately 1 year post treatment
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
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
Time Frame: post treatment during approximate follow up periods 6mo and 12mo clinical follow up
bleeding rate post treatment.
post treatment during approximate follow up periods 6mo and 12mo clinical follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of South Carolina

Collaborators

Northwestern University
University of Illinois at Chicago
Stony Brook University
Vanderbilt University
Indiana University
Methodist Health System
Providence Health & Services
Royal University Hospital Foundation
Albany Medical College

Investigators

  • Principal Investigator: Henry Woo, SUNY - Stonybrook
  • Principal Investigator: Arthur Adam, MD, Baptist Hospital
  • Principal Investigator: Mike Kelly, Royal University Hospital Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (ACTUAL)

June 1, 2015

Study Completion (ACTUAL)

June 1, 2015

Study Registration Dates

First Submitted

August 30, 2011

First Submitted That Met QC Criteria

September 29, 2011

First Posted (ESTIMATE)

October 3, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

March 24, 2016

Last Update Submitted That Met QC Criteria

March 23, 2016

Last Verified

April 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20137 (Other Identifier: City of Hope Medical Center)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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