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Analysis Of Intracranial Artery Lesions Using 2-D/3D Phase Contrast MR

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00710281
Recruitment Status : Withdrawn (Investigator is no longer at study site)
First Posted : July 4, 2008
Last Update Posted : September 18, 2013
VasSol®-Nova Software
Information provided by (Responsible Party):
Lahey Clinic

Brief 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.

Condition or disease Intervention/treatment Phase
Intracranial Arterial Aneurysm Radiation: Additional scan time on standard MR angiography Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Hemodynamic Analysis Of Intracranial Artery And Associated Lesions Using 2-D/3D Phase Contrast MR Angiography Focused On Wall Shear Stress Measurement
Study Start Date : March 2008
Actual Primary Completion Date : July 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aneurysms

Arm Intervention/treatment
2D/3D Phase contrast MR Radiation: Additional scan time on standard MR angiography

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


Other Names:
  • MRI
  • Phase contrast MR
  • 2D MR
  • 3D MR

Primary Outcome Measures :
  1. Identify, measure and map the Wall Shear Stress (WSS) measurements and affects in subarachnoid aneurysm developement. [ Time Frame: Duration of the MRA test ]

Secondary Outcome Measures :
  1. Develope predictor to identify risk factors of possible future aneurysm rupture and SAH [ Time Frame: Duration of MRA test ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Unruptured and ruptured adult (>18 years) intracranial arterial aneurysm patients

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00710281

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United States, Massachusetts
Lahey Clinic, Inc.
Burlington, Massachusetts, United States, 01805
Sponsors and Collaborators
Lahey Clinic
VasSol®-Nova Software
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Principal Investigator: Seon Kyu Lee, M.D., Ph.D. Lahey Clinic, Inc.

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Responsible Party: Lahey Clinic Identifier: NCT00710281     History of Changes
Other Study ID Numbers: 2008-020
First Posted: July 4, 2008    Key Record Dates
Last Update Posted: September 18, 2013
Last Verified: September 2013

Keywords provided by Lahey Clinic:
Intracranial Aneurysm
Subarachnoid arterial aneurysm
Brain Aneurysm
Cerebral Aneurysm
Wall Shear Stress(WSS)
Hemodynamic Stress
Subarachnoid Hemorrhage(SAH)

Additional relevant MeSH terms:
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Vascular Diseases
Cardiovascular Diseases