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

This study has been withdrawn prior to enrollment.
(Investigator is no longer at study site)
Sponsor:
Collaborator:
VasSol®-Nova Software
Information provided by (Responsible Party):
Lahey Clinic
ClinicalTrials.gov Identifier:
NCT00710281
First received: July 1, 2008
Last updated: September 17, 2013
Last verified: September 2013

July 1, 2008
September 17, 2013
March 2008
July 2011   (final data collection date for primary outcome measure)
Identify, measure and map the Wall Shear Stress (WSS) measurements and affects in subarachnoid aneurysm developement. [ Time Frame: Duration of the MRA test ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00710281 on ClinicalTrials.gov Archive Site
Develope predictor to identify risk factors of possible future aneurysm rupture and SAH [ Time Frame: Duration of MRA test ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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

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.

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.

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Intracranial Arterial Aneurysm
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

Arms:

Other Names:
  • MRI
  • Phase contrast MR
  • 2D MR
  • 3D MR
2D/3D Phase contrast MR
Intervention: Radiation: Additional scan time on standard MR angiography

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
December 2011
July 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00710281
2008-020
No
Lahey Clinic
Lahey Clinic
VasSol®-Nova Software
Principal Investigator: Seon Kyu Lee, M.D., Ph.D. Lahey Clinic, Inc.
Lahey Clinic
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP