Brain AneurysmPhase 4NCT01444664
Aneurysm Wall Histology Registry
A Phase 4 study testing Surgical Clipping of Aneurysm in people with Brain Aneurysm, run by Medical University of South Carolina at 10 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Brain Aneurysm
- What is being tested?
- Surgical Clipping of Aneurysm
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 10 sitesin 2 countries
- Study dates
- Jun 2010to Jun 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
United States9 sites
Albany Medical Center
Albany, New York, 12208-3412
Medical University of South Carolina
Charleston, South Carolina, 29401
Northwestern University
Chicago, Illinois, 60611
University Of Illinois
Chicago, Illinois, 60612
Goodman Campbell
Indianapolis, Indiana, 46202
Methodist Healthcare - Memphis
Memphis, Tennessee, 38104
Vanderbilt University
Nashville, Tennessee, 37240
Providence Health
Portland, Oregon, 97225
SUNY - Stonybrook University Medical Center
Stony Brook, New York, 11794
About this study
Official title: 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.
Read the 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).
- Conditions
- Brain Aneurysm
- Being tested
- Surgical Clipping of Aneurysm
- Medical subject headings
- Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical Clipping of AneurysmProcedure or surgery
Surgical clipping of intracranial aneurysm
| Study group | Role | What they receive |
|---|---|---|
| Aneurysm | Experimental | Not described Receives: Procedure: Surgical Clipping of Aneurysm |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: an average of 1 day after aneurysm treatment an analysis of the histological sample, CSF sample, and plasma samples will occur
Secondary outcomes (3)
Treatment related morbidity and mortality
Secondary analyses will be performed to compare treatment related morbidity and mortality,
Measured: 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
Measured: 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.
Measured: post treatment during approximate follow up periods 6mo and 12mo clinical follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2011 (estimated)
- Study startJun 2010
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (35)Papers the sponsor has linked to this study.
- Other trials for Brain AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- Albany Medical College, Northwestern University, Stony Brook University, Royal University Hospital Foundation, Indiana University, Providence Health & Services, University of Illinois at Chicago, Vanderbilt University, Methodist Health System
- Responsible party
- Sponsor
- Investigators
- Henry Woo, Principal investigator, SUNY - StonybrookArthur Adam, MD, Principal investigator, Baptist HospitalMike Kelly, Principal investigator, Royal University Hospital Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01444664
- Sponsor's protocol ID
- 20137
- Status last verified
- Apr 2015
- First submitted
- 30 Aug 2011
- Last updated
- 24 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Weir B. Unruptured intracranial aneurysms: a review. J Neurosurg. 2002 Jan;96(1):3-42. doi: 10.3171/jns.2002.96.1.0003.
PubMed 11794601Ronkainen A, Hernesniemi J. Subarachnoid haemorrhage of unknown aetiology. Acta Neurochir (Wien). 1992;119(1-4):29-34. doi: 10.1007/BF01541778.
PubMed 1481749STEHBENS WE. ANEURYSMS AND ANATOMICAL VARIATION OF CEREBRAL ARTERIES. Arch Pathol. 1963 Jan;75:45-64. No abstract available.
PubMed 14087271Brisman JL, Song JK, Newell DW. Cerebral aneurysms. N Engl J Med. 2006 Aug 31;355(9):928-39. doi: 10.1056/NEJMra052760. No abstract available.
PubMed 16943405Juvela 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. doi: 10.1161/01.str.24.5.639.
PubMed 8488517Juvela S. Prehemorrhage risk factors for fatal intracranial aneurysm rupture. Stroke. 2003 Aug;34(8):1852-7. doi: 10.1161/01.STR.0000080380.56799.DD. Epub 2003 Jun 26.
PubMed 12829865Sahs AL. Observations on the pathology of saccular aneurysms. J Neurosurg. 1966 Apr;24(4):792-806. doi: 10.3171/jns.1966.24.4.0792. No abstract available.
PubMed 5934137Scanarini 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. doi: 10.1007/BF01587953.
PubMed 707175Krex D, Schackert HK, Schackert G. Genesis of cerebral aneurysms--an update. Acta Neurochir (Wien). 2001;143(5):429-48; discussion 448-9. doi: 10.1007/s007010170072.
PubMed 11482693Kataoka 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. doi: 10.1161/01.str.30.7.1396.
PubMed 10390313Chyatte D, Bruno G, Desai S, Todor DR. Inflammation and intracranial aneurysms. Neurosurgery. 1999 Nov;45(5):1137-46; discussion 1146-7. doi: 10.1097/00006123-199911000-00024.
PubMed 10549930Bruno G, Todor R, Lewis I, Chyatte D. Vascular extracellular matrix remodeling in cerebral aneurysms. J Neurosurg. 1998 Sep;89(3):431-40. doi: 10.3171/jns.1998.89.3.0431.
PubMed 9724118Nakajima 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. doi: 10.1007/s004010000220.
PubMed 11045669Kosierkiewicz TA, Factor SM, Dickson DW. Immunocytochemical studies of atherosclerotic lesions of cerebral berry aneurysms. J Neuropathol Exp Neurol. 1994 Jul;53(4):399-406. doi: 10.1097/00005072-199407000-00012.
PubMed 8021714Aydin 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. doi: 10.1007/s004010050856.
PubMed 9678510
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aneurysm Wall Histology and Correlation With Cerebrospinal Fluid and Blood Plasma Registry
- ClinicalTrials.gov ID
- NCT01444664
- Acronym / sponsor ID
- 20137
- Conditions
- Brain Aneurysm
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- Albany Medical College, Northwestern University, Stony Brook University, Royal University Hospital Foundation, Indiana University, Providence Health & Services, University of Illinois at Chicago, Vanderbilt University, Methodist Health System
- Study start
- Jun 2010
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 3 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aneurysm | Experimental | Procedure: Surgical Clipping of Aneurysm |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (14 listed)
- Any patient that has a ruptured intracranial aneurysm
- Any Pediatric patients
- Any patient presenting with any pre-treatment intracranial lesions
- Any meningitis type symptoms
- Medical or surgical co-morbidities such that the patient's life expectancy is less than 1 year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical Clipping of AneurysmSurgical clipping of intracranial aneurysm | Procedure or surgery | Aneurysm |
Primary outcome
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.
3 secondary outcomes
Treatment related morbidity and mortality
Time frame: 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
Bleeding Rate
Time frame: post treatment during approximate follow up periods 6mo and 12mo clinical follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2016.
- Background: PubMed 11794601Weir B. Unruptured intracranial aneurysms: a review. J Neurosurg. 2002 Jan;96(1):3-42. doi: 10.3171/jns.2002.96.1.0003.
- Background: PubMed 1481749Ronkainen A, Hernesniemi J. Subarachnoid haemorrhage of unknown aetiology. Acta Neurochir (Wien). 1992;119(1-4):29-34. doi: 10.1007/BF01541778.
- Background: PubMed 14087271STEHBENS WE. ANEURYSMS AND ANATOMICAL VARIATION OF CEREBRAL ARTERIES. Arch Pathol. 1963 Jan;75:45-64. No abstract available.
- Background: PubMed 16943405Brisman JL, Song JK, Newell DW. Cerebral aneurysms. N Engl J Med. 2006 Aug 31;355(9):928-39. doi: 10.1056/NEJMra052760. No abstract available.
- Background: PubMed 8488517Juvela 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. doi: 10.1161/01.str.24.5.639.
- Background: PubMed 12829865Juvela S. Prehemorrhage risk factors for fatal intracranial aneurysm rupture. Stroke. 2003 Aug;34(8):1852-7. doi: 10.1161/01.STR.0000080380.56799.DD. Epub 2003 Jun 26.
- Background: PubMed 5934137Sahs AL. Observations on the pathology of saccular aneurysms. J Neurosurg. 1966 Apr;24(4):792-806. doi: 10.3171/jns.1966.24.4.0792. No abstract available.
- Background: PubMed 707175Scanarini 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. doi: 10.1007/BF01587953.
- Background: PubMed 11482693Krex D, Schackert HK, Schackert G. Genesis of cerebral aneurysms--an update. Acta Neurochir (Wien). 2001;143(5):429-48; discussion 448-9. doi: 10.1007/s007010170072.
- Background: PubMed 10390313Kataoka 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. doi: 10.1161/01.str.30.7.1396.
- Background: PubMed 10549930Chyatte D, Bruno G, Desai S, Todor DR. Inflammation and intracranial aneurysms. Neurosurgery. 1999 Nov;45(5):1137-46; discussion 1146-7. doi: 10.1097/00006123-199911000-00024.
- Background: PubMed 9724118Bruno G, Todor R, Lewis I, Chyatte D. Vascular extracellular matrix remodeling in cerebral aneurysms. J Neurosurg. 1998 Sep;89(3):431-40. doi: 10.3171/jns.1998.89.3.0431.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henry Woo principal investigator
SUNY - Stonybrook
Arthur Adam, MD principal investigator
Baptist Hospital
Mike Kelly principal investigator
Royal University Hospital Foundation
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Surgical Clipping of Aneurysm in people with Brain Aneurysm, run by Medical University of South Carolina at 10 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01444664, which also lists 35 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2016.