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Clinical Trials/NCT00710281
NCT00710281WithdrawnNot Applicable

Hemodynamic Analysis Of Intracranial Artery And Associated Lesions Using 2-D/3D Phase Contrast MR Angiography Focused On Wall Shear Stress Measurement

Lahey Clinic1 site in 1 countryStarted: March 1, 2008Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Withdrawn
Locations
1
Primary Endpoint
Identify, measure and map the Wall Shear Stress (WSS) measurements and affects in subarachnoid aneurysm developement.

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
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.

Arms & Interventions

2D/3D Phase contrast MR

Other

Intervention: Additional scan time on standard MR angiography (Radiation)

Outcomes

Primary Outcomes

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

Time Frame: Duration of the MRA test

Secondary Outcomes

  • Develope predictor to identify risk factors of possible future aneurysm rupture and SAH(Duration of MRA test)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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