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Completed

NCT Number: NCT01444664

Aneurysm Wall Histology 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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Royal University Hospital, Saskatoon, Ontario, Canada

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Surgical Clipping of Aneurysm

Procedure

Surgical clipping of intracranial aneurysm

Primary outcomes

  1. 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 outcomes

  1. 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,

  2. 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

  3. Bleeding Rate

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

    bleeding rate post treatment.

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Collaborators

  • 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

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Oct 3, 2011
Registry last updated
Mar 24, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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