Intracranial Arterial AneurysmNCT00710281
Analysis Of Intracranial Artery Lesions Using 2-D/3D Phase Contrast MR
A study testing Additional scan time on standard MR angiography in people with Intracranial Arterial Aneurysm, run by Lahey Clinic at 1 site in United States.
Trial summary
Using phase contrast MR Angiography with NOVA® Software, this study intends to identify,evaluate and map intracranial aneurysm development as well as develope a predicator for future morphological changes of aneurysms and possible risk of future rupture. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracranial Arterial Aneurysm
- What is being tested?
- Additional scan time on standard MR angiography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to Dec 2011
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unruptured and ruptured adult (>18 years) intracranial arterial aneurysm patients
Who cannot join
- Less than 18 years old
- Chronic renal failure patients
- Incompetent patient who cannot give consent for routine phase contrast MR Angiography and his/her surrogate decision maker is not available
- Any patients with a contraindication to having a standard MRI examination, such as phase maker, orbital metallic foreign body, etc.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hemodynamic Analysis Of Intracranial Artery And Associated Lesions Using 2-D/3D Phase Contrast MR Angiography Focused On Wall Shear Stress Measurement
Using phase contrast MR Angiography with NOVA® Software, this study intends to identify,evaluate and map intracranial aneurysm development as well as develope a predicator for future morphological changes of aneurysms and possible risk of future rupture.
Read the detailed description
Hemodynamic stress toward the wall of intracranial artery with associated genuine defects of wall remodeling capacity is one of many hypotheses of subarachnoid aneurysm development. In addition, hemodynamic stress toward an aneurysm wall may play a very significant role for the rupture of an aneurysm creating acute Subarachnoid hemorrhage. We think the Wall Shear Stress (WSS) measurement toward an intracranial arterial wall and intracranial aneurysmal wall may provide valuable information for understanding of intracranial aneurysm development as well as predicting future morphological changes of aneurysm and possibly risk of future rupture. This study is significant especially in the management of unruptured subarachnoid arterial aneurysm patients and identifying patients who have higher rupture risks for active treatments such as surgical clipping or coiling to prevent unnecessary but potentially risky procedures.
Gadolinium MR Angiography with NOVA® Software will be used to measure the arterial wall shear stress (WSS) for patients with an intracranial arterial aneurysm. The aneurysm will be identified, blood flow, velocity, volume, vascular diameter and the direction of blood measurements will be taken using NOVA® Software at each point of interest. A WSS map of target intracranial artery and/or aneurysm sac will be created and matched with morphological features providing a clue to understand the the relationships between hemodynamic parameters, especially WSS and morphological changes.
- Conditions
- Intracranial Arterial Aneurysm
- Being tested
- Additional scan time on standard MR angiography
- Keywords
- Intracranial Aneurysm, Subarachnoid arterial aneurysm, Aneurysm, Brain Aneurysm, Cerebral Aneurysm, Wall Shear Stress(WSS), Hemodynamic Stress, Subarachnoid Hemorrhage(SAH)
- Medical subject headings
- Intracranial Aneurysm, Aneurysm, Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Additional scan time on standard MR angiographyRadiation
Also called MRI, Phase contrast MR, 2D MR, 3D MR
Procedure/Surgery: Additional 5 minutes scan time to standard MR angiography
Using the Nova® Software, an additional 5 minutes scan time will be required in order to identify aneurysm, select target artery, and complete measurements
Arms:
| Study group | Role | What they receive |
|---|---|---|
| 2D/3D Phase contrast MR | Other | Not described Receives: Radiation: Additional scan time on standard MR angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify, measure and map the Wall Shear Stress (WSS) measurements and affects in subarachnoid aneurysm developement.
Measured: Duration of the MRA test
Secondary outcomes (1)
Develope predictor to identify risk factors of possible future aneurysm rupture and SAH
Measured: Duration of MRA test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2008 (estimated)
- Study startMar 2008
- Primary completionJul 2011
- Study completionDec 2011
Why it stopped: Investigator is no longer at study site
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Intracranial Arterial 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lahey Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- VasSol®-Nova Software
- Responsible party
- Sponsor
- Investigators
- Seon Kyu Lee, M.D., Ph.D., Principal investigator, Lahey Clinic, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00710281
- Sponsor's protocol ID
- 2008-020
- Status last verified
- Sep 2013
- First submitted
- 1 Jul 2008
- Last updated
- 18 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Amin-Hanjani S, Du X, Zhao M, Walsh K, Malisch TW, Charbel FT. Use of quantitative magnetic resonance angiography to stratify stroke risk in symptomatic vertebrobasilar disease. Stroke. 2005 Jun;36(6):1140-5. doi: 10.1161/01.STR.0000166195.63276.7c. Epub 2005 May 12.
PubMed 15890993Zhao M, Amin-Hanjani S, Ruland S, Curcio AP, Ostergren L, Charbel FT. Regional cerebral blood flow using quantitative MR angiography. AJNR Am J Neuroradiol. 2007 Sep;28(8):1470-3. doi: 10.3174/ajnr.A0582.
PubMed 17846193Ahn S, Shin D, Tateshima S, Tanishita K, Vinuela F, Sinha S. Fluid-induced wall shear stress in anthropomorphic brain aneurysm models: MR phase-contrast study at 3 T. J Magn Reson Imaging. 2007 Jun;25(6):1120-30. doi: 10.1002/jmri.20928.
PubMed 17520716
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamic Analysis Of Intracranial Artery And Associated Lesions Using 2-D/3D Phase Contrast MR Angiography Focused On Wall Shear Stress Measurement
- ClinicalTrials.gov ID
- NCT00710281
- Acronym / sponsor ID
- 2008-020
- Conditions
- Intracranial Arterial Aneurysm
- Keywords
- Intracranial Aneurysm, Subarachnoid arterial aneurysm, Aneurysm, Brain Aneurysm, Cerebral Aneurysm, Wall Shear Stress(WSS), Hemodynamic Stress, Subarachnoid Hemorrhage(SAH)
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Investigator is no longer at study site
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Lahey ClinicUniversity, hospital or other
- Collaborators
- VasSol®-Nova Software
- Study start
- Mar 2008
- Primary completion
- Jul 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 4 Jul 2008 (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.
Using phase contrast MR Angiography with NOVA® Software, this study intends to identify,evaluate and map intracranial aneurysm development as well as develope a predicator for future morphological changes of aneurysms and possible risk of future rupture.
Detailed description
Hemodynamic stress toward the wall of intracranial artery with associated genuine defects of wall remodeling capacity is one of many hypotheses of subarachnoid aneurysm development. In addition, hemodynamic stress toward an aneurysm wall may play a very significant role for the rupture of an aneurysm creating acute Subarachnoid hemorrhage. We think the Wall Shear Stress (WSS) measurement toward an intracranial arterial wall and intracranial aneurysmal wall may provide valuable information for understanding of intracranial aneurysm development as well as predicting future morphological changes of aneurysm and possibly risk of future rupture. This study is significant especially in the management of unruptured subarachnoid arterial aneurysm patients and identifying patients who have higher rupture risks for active treatments such as surgical clipping or coiling to prevent unnecessary but potentially risky procedures.
Gadolinium MR Angiography with NOVA® Software will be used to measure the arterial wall shear stress (WSS) for patients with an intracranial arterial aneurysm. The aneurysm will be identified, blood flow, velocity, volume, vascular diameter and the direction of blood measurements will be taken using NOVA® Software at each point of interest. A WSS map of target intracranial artery and/or aneurysm sac will be created and matched with morphological features providing a clue to understand the the relationships between hemodynamic parameters, especially WSS and morphological changes.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 2D/3D Phase contrast MR | Other | Radiation: Additional scan time on standard MR angiography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Unruptured and ruptured adult (>18 years) intracranial arterial aneurysm patients
Key exclusion criteria (4 listed)
- Less than 18 years old
- Chronic renal failure patients
- Incompetent patient who cannot give consent for routine phase contrast MR Angiography and his/her surrogate decision maker is not available
- Any patients with a contraindication to having a standard MRI examination, such as phase maker, orbital metallic foreign body, etc.
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 |
|---|---|---|
| Additional scan time on standard MR angiographyAlso: MRI, Phase contrast MR, 2D MR, 3D MRProcedure/Surgery: Additional 5 minutes scan time to standard MR angiography Using the Nova® Software, an additional 5 minutes scan time will be required in order to identify aneurysm, select target artery, and complete measurements Arms: | Radiation | 2D/3D Phase contrast MR |
Primary outcome
Identify, measure and map the Wall Shear Stress (WSS) measurements and affects in subarachnoid aneurysm developement.
Time frame: Duration of the MRA test
1 secondary outcome
Develope predictor to identify risk factors of possible future aneurysm rupture and SAH
Time frame: Duration of MRA test
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2013.
- Background: PubMed 15890993Amin-Hanjani S, Du X, Zhao M, Walsh K, Malisch TW, Charbel FT. Use of quantitative magnetic resonance angiography to stratify stroke risk in symptomatic vertebrobasilar disease. Stroke. 2005 Jun;36(6):1140-5. doi: 10.1161/01.STR.0000166195.63276.7c. Epub 2005 May 12.
- Background: PubMed 17846193Zhao M, Amin-Hanjani S, Ruland S, Curcio AP, Ostergren L, Charbel FT. Regional cerebral blood flow using quantitative MR angiography. AJNR Am J Neuroradiol. 2007 Sep;28(8):1470-3. doi: 10.3174/ajnr.A0582.
- Background: PubMed 17520716Ahn S, Shin D, Tateshima S, Tanishita K, Vinuela F, Sinha S. Fluid-induced wall shear stress in anthropomorphic brain aneurysm models: MR phase-contrast study at 3 T. J Magn Reson Imaging. 2007 Jun;25(6):1120-30. doi: 10.1002/jmri.20928.
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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.
Seon Kyu Lee, M.D., Ph.D. principal investigator
Lahey Clinic, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Additional scan time on standard MR angiography in people with Intracranial Arterial Aneurysm, run by Lahey Clinic at 1 site in United States.
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 1 inclusion and 4 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: withdrawn, as of the sponsor's last update on 18 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Identify, measure and map the Wall Shear Stress (WSS) measurements and affects in subarachnoid aneurysm developement. (time frame: Duration of the MRA test). 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 NCT00710281, which also lists 3 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 18 Sep 2013.