Clinical Trials Directory

Trials / Withdrawn

WithdrawnNCT00710281

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

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

Status
Withdrawn
Phase
N/A
Study type
Interventional
Enrollment
0 (actual)
Sponsor
Lahey Clinic · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
RADIATIONAdditional scan time on standard MR angiographyProcedure/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:

Timeline

Start date
2008-03-01
Primary completion
2011-07-01
Completion
2011-12-01
First posted
2008-07-04
Last updated
2013-09-18

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00710281. Inclusion in this directory is not an endorsement.