Aneurysm Wall Histology Registry - Full Text View

Purpose

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.

Condition	Intervention	Phase
Brain Aneurysm	Procedure: Surgical Clipping of Aneurysm	Phase 4

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Aneurysm Wall Histology and Correlation With Cerebrospinal Fluid and Blood Plasma Registry

Resource links provided by NLM:

MedlinePlus related topics: Aneurysms Brain Aneurysm

U.S. FDA Resources

Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]
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 [ Time Frame: up to approximately 1 year post treatment ] [ Designated as safety issue: Yes ]
Secondary analyses will be performed to compare treatment related morbidity and mortality,
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 ] [ Designated as safety issue: No ]
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 [ Time Frame: post treatment during approximate follow up periods 6mo and 12mo clinical follow up ] [ Designated as safety issue: Yes ]
bleeding rate post treatment.

Estimated Enrollment:	50
Study Start Date:	June 2010
Estimated Study Completion Date:	June 2014
Estimated Primary Completion Date:	June 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Aneurysm	Procedure: Surgical Clipping of Aneurysm Surgical clipping of intracranial aneurysm

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).

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01444664

Locations

United States, Florida
University of Florida Hospital
Gainesville, Florida, United States, 32610-0261
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, New York
Albany Medical Center
Albany, New York, United States, 12208-3412
SUNY - Stonybrook University Medical Center
Stonybrook, New York, United States, 11794
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29401
United States, Tennessee
Baptist Hospital - Collerville
Collierville, Tennessee, United States, 38120
Canada, Ontario
Royal University Hospital
Saskatoon, Ontario, Canada, S7N OW8

Sponsors and Collaborators

Medical University of South Carolina

Albany Medical College

Northwestern University

Stony Brook University

Baptist Memorial Health Care Corporation

University of Florida

Royal University Hospital Foundation

Investigators

Principal Investigator:	Alan Boulos, MD	Albany Medical College
Principal Investigator:	Bernard Bendok	Northwestern University
Principal Investigator:	Henry Woo	SUNY - Stonybrook
Principal Investigator:	Arthur Adam, MD	Baptist Hospital
Principal Investigator:	J. Mocco	University of Florida Hospital
Principal Investigator:	Mike Kelly	Royal University Hospital Foundation

More Information

Publications:

Weir B. Unruptured intracranial aneurysms: a review. J Neurosurg. 2002 Jan;96(1):3-42. Review.

Ronkainen A, Hernesniemi J. Subarachnoid haemorrhage of unknown aetiology. Acta Neurochir (Wien). 1992;119(1-4):29-34.

STEHBENS WE. ANEURYSMS AND ANATOMICAL VARIATION OF CEREBRAL ARTERIES. Arch Pathol. 1963 Jan;75:45-64. No abstract available.

Brisman JL, Song JK, Newell DW. Cerebral aneurysms. N Engl J Med. 2006 Aug 31;355(9):928-39. Review. No abstract available.

Juvela S, Hillbom M, Numminen H, Koskinen P. Cigarette smoking and alcohol consumption as risk factors for aneurysmal subarachnoid hemorrhage. Stroke. 1993 May;24(5):639-46.

Juvela S. Prehemorrhage risk factors for fatal intracranial aneurysm rupture. Stroke. 2003 Aug;34(8):1852-7. Epub 2003 Jun 26.

Sahs AL. Observations on the pathology of saccular aneurysms. J Neurosurg. 1966 Apr;24(4):792-806. No abstract available.

Scanarini M, Mingrino S, Giordano R, Baroni A. Histological and ultrastructural study of intracranial saccular aneurysmal wall. Acta Neurochir (Wien). 1978;43(3-4):171-82.

Krex D, Schackert HK, Schackert G. Genesis of cerebral aneurysms--an update. Acta Neurochir (Wien). 2001;143(5):429-48; discussion 448-9. Review.

Kataoka K, Taneda M, Asai T, Kinoshita A, Ito M, Kuroda R. Structural fragility and inflammatory response of ruptured cerebral aneurysms. A comparative study between ruptured and unruptured cerebral aneurysms. Stroke. 1999 Jul;30(7):1396-401.

Chyatte D, Bruno G, Desai S, Todor DR. Inflammation and intracranial aneurysms. Neurosurgery. 1999 Nov;45(5):1137-46; discussion 1146-7.

Bruno G, Todor R, Lewis I, Chyatte D. Vascular extracellular matrix remodeling in cerebral aneurysms. J Neurosurg. 1998 Sep;89(3):431-40.

Nakajima N, Nagahiro S, Sano T, Satomi J, Satoh K. Phenotypic modulation of smooth muscle cells in human cerebral aneurysmal walls. Acta Neuropathol. 2000 Nov;100(5):475-80.

Kosierkiewicz TA, Factor SM, Dickson DW. Immunocytochemical studies of atherosclerotic lesions of cerebral berry aneurysms. J Neuropathol Exp Neurol. 1994 Jul;53(4):399-406.

Aydin F. Do human intracranial arteries lack vasa vasorum? A comparative immunohistochemical study of intracranial and systemic arteries. Acta Neuropathol. 1998 Jul;96(1):22-8.

Ushikoshi S, Kikuchi Y, Houkin K, Miyasaka K, Abe H. Aggravation of brainstem symptoms caused by a large superior cerebellar artery aneurysm after embolization by Guglielmi detachable coils--case report. Neurol Med Chir (Tokyo). 1999 Jul;39(7):524-9.

Meyers PM, Lavine SD, Fitzsimmons BF, Commichau C, Parra A, Mayer SA, Solomon RA, Connolly ES Jr. Chemical meningitis after cerebral aneurysm treatment using two second-generation aneurysm coils: report of two cases. Neurosurgery. 2004 Nov;55(5):1222.

Berenstein A, Song JK, Niimi Y, Namba K, Heran NS, Brisman JL, Nahoum MC, Madrid M, Langer DJ, Kupersmith MJ. Treatment of cerebral aneurysms with hydrogel-coated platinum coils (HydroCoil): early single-center experience. AJNR Am J Neuroradiol. 2006 Oct;27(9):1834-40.

Bendszus M, Solymosi L. Cerecyte coils in the treatment of intracranial aneurysms: a preliminary clinical study. AJNR Am J Neuroradiol. 2006 Nov-Dec;27(10):2053-7.

Deshaies EM, Adamo MA, Boulos AS. A prospective single-center analysis of the safety and efficacy of the hydrocoil embolization system for the treatment of intracranial aneurysms. J Neurosurg. 2007 Feb;106(2):226-33.

Im SH, Han MH, Kwon BJ, Jung C, Kim JE, Han DH. Aseptic meningitis after embolization of cerebral aneurysms using hydrogel-coated coils: report of three cases. AJNR Am J Neuroradiol. 2007 Mar;28(3):511-2.

Stracke CP, Krings T, Möller-Hartmann W, Mahdavi A, Klug N. Severe inflammatory reaction of the optic system after endovascular treatment of a supraophthalmic aneurysm with bioactive coils. AJNR Am J Neuroradiol. 2007 Aug;28(7):1401-2.

Schmidt GW, Oster SF, Golnik KC, Tumialán LM, Biousse V, Turbin R, Prestigiacomo CJ, Miller NR. Isolated progressive visual loss after coiling of paraclinoid aneurysms. AJNR Am J Neuroradiol. 2007 Nov-Dec;28(10):1882-9.

Kang HS, Han MH, Lee TH, Shin YS, Roh HG, Kwon OK, Kwon BJ, Kim SY, Kim SH, Byun HS. Embolization of intracranial aneurysms with hydrogel-coated coils: result of a Korean multicenter trial. Neurosurgery. 2007 Jul;61(1):51-8; discussion 58-9.

Pickett GE, Laitt RD, Herwadkar A, Hughes DG. Visual pathway compromise after hydrocoil treatment of large ophthalmic aneurysms. Neurosurgery. 2007 Oct;61(4):E873-4; discussion E874.

Horie N, Kitagawa N, Morikawa M, Tsutsumi K, Kaminogo M, Nagata I. Progressive perianeurysmal edema induced after endovascular coil embolization. Report of three cases and review of the literature. J Neurosurg. 2007 May;106(5):916-20. Review.

Marchan EM, Sekula RF Jr, Ku A, Williams R, O'Neill BR, Wilberger JE, Quigley MR. Hydrogel coil-related delayed hydrocephalus in patients with unruptured aneurysms. J Neurosurg. 2008 Aug;109(2):186-90.

Fanning NF, Willinsky RA, ter Brugge KG. Wall enhancement, edema, and hydrocephalus after endovascular coil occlusion of intradural cerebral aneurysms. J Neurosurg. 2008 Jun;108(6):1074-86.

White JB, Cloft HJ, Kallmes DF. But did you use HydroCoil? Perianeurysmal edema and hydrocephalus with bare platinum coils. AJNR Am J Neuroradiol. 2008 Feb;29(2):299-300. Epub 2007 Nov 16.

Marden FA, Putman CM. Perianeurysm edema with second-generation bioactive coils. Surg Neurol. 2008 Jun;69(6):627-32; discussion 632. Epub 2007 Oct 31.

Turner RD, Byrne JV, Kelly ME, Mitsos AP, Gonugunta V, Lalloo S, Rasmussen PA, Fiorella D. Delayed visual deficits and monocular blindness after endovascular treatment of large and giant paraophthalmic aneurysms. Neurosurgery. 2008 Sep;63(3):469-74; discussion 474-5.

Im SH, Han MH, Kwon OK, Kwon BJ, Kim SH, Kim JE, Oh CW. Endovascular coil embolization of 435 small asymptomatic unruptured intracranial aneurysms: procedural morbidity and patient outcome. AJNR Am J Neuroradiol. 2009 Jan;30(1):79-84. Epub 2008 Sep 3.

Killer M, Baltsavias G, Huemer M, Richling B. Visual worsening after incomplete coiling of a small asymptomatic aneurysm: case report and review of the literature. Minim Invasive Neurosurg. 2009 Feb;52(1):39-43. Epub 2009 Feb 26. Review.

Nishino K, Ito Y, Hasegawa H, Shimbo J, Kikuchi B, Fujii Y. Development of cranial nerve palsy shortly after endosaccular embolization for asymptomatic cerebral aneurysm: report of two cases and literature review. Acta Neurochir (Wien). 2009 Apr;151(4):379-83. Epub 2009 Mar 5.

Hara A, Yoshimi N, Mori H. Evidence for apoptosis in human intracranial aneurysms. Neurol Res. 1998 Mar;20(2):127-30.

Responsible Party:	Medical University of South Carolina
ClinicalTrials.gov Identifier:	NCT01444664 History of Changes
Other Study ID Numbers:	20137
Study First Received:	August 30, 2011
Last Updated:	October 31, 2012
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Aneurysm
Intracranial Aneurysm
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases

Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on May 22, 2013