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

NCT ID: NCT00710281

Last Updated: 2013-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2011-12-31

Brief Summary

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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

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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

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Intracranial Arterial Aneurysm

Keywords

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Intracranial Aneurysm Subarachnoid arterial aneurysm Aneurysm Brain Aneurysm Cerebral Aneurysm Wall Shear Stress(WSS) Hemodynamic Stress Subarachnoid Hemorrhage(SAH)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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2D/3D Phase contrast MR

Group Type OTHER

Additional scan time on standard MR angiography

Intervention Type RADIATION

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:

Interventions

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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

Arms:

Intervention Type RADIATION

Other Intervention Names

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MRI Phase contrast MR 2D MR 3D MR

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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VasSol®-Nova Software

UNKNOWN

Sponsor Role collaborator

Lahey Clinic

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Seon Kyu Lee, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Lahey Clinic, Inc.

Locations

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Lahey Clinic, Inc.

Burlington, Massachusetts, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 15890993 (View on PubMed)

Zhao 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.

Reference Type BACKGROUND
PMID: 17846193 (View on PubMed)

Ahn 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.

Reference Type BACKGROUND
PMID: 17520716 (View on PubMed)

Other Identifiers

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2008-020

Identifier Type: -

Identifier Source: org_study_id