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

Primary Purpose

Intracranial Arterial Aneurysm

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Additional scan time on standard MR angiography
Sponsored by
Lahey Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Intracranial Arterial Aneurysm focused on measuring Intracranial Aneurysm, Subarachnoid arterial aneurysm, Aneurysm, Brain Aneurysm, Cerebral Aneurysm, Wall Shear Stress(WSS), Hemodynamic Stress, Subarachnoid Hemorrhage(SAH)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Lahey Clinic, Inc.

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

2D/3D Phase contrast MR

Arm Description

Outcomes

Primary Outcome Measures

Identify, measure and map the Wall Shear Stress (WSS) measurements and affects in subarachnoid aneurysm developement.

Secondary Outcome Measures

Develope predictor to identify risk factors of possible future aneurysm rupture and SAH

Full Information

First Posted
July 1, 2008
Last Updated
September 17, 2013
Sponsor
Lahey Clinic
Collaborators
VasSol®-Nova Software
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1. Study Identification

Unique Protocol Identification Number
NCT00710281
Brief Title
Analysis Of Intracranial Artery Lesions Using 2-D/3D Phase Contrast MR
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 Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Withdrawn
Why Stopped
Investigator is no longer at study site
Study Start Date
March 2008 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lahey Clinic
Collaborators
VasSol®-Nova Software

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracranial Arterial Aneurysm
Keywords
Intracranial Aneurysm, Subarachnoid arterial aneurysm, Aneurysm, Brain Aneurysm, Cerebral Aneurysm, Wall Shear Stress(WSS), Hemodynamic Stress, Subarachnoid Hemorrhage(SAH)

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
2D/3D Phase contrast MR
Arm Type
Other
Intervention Type
Radiation
Intervention Name(s)
Additional scan time on standard MR angiography
Other Intervention Name(s)
MRI, Phase contrast MR, 2D MR, 3D MR
Intervention Description
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:
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Develope predictor to identify risk factors of possible future aneurysm rupture and SAH
Time Frame
Duration of MRA test

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seon Kyu Lee, M.D., Ph.D.
Organizational Affiliation
Lahey Clinic, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lahey Clinic, Inc.
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01805
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15890993
Citation
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.
Results Reference
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PubMed Identifier
17846193
Citation
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.
Results Reference
background
PubMed Identifier
17520716
Citation
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.
Results Reference
background

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

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