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This study has been withdrawn prior to enrollment.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
  Purpose

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.


Condition Intervention
Intracranial Arterial Aneurysm
Radiation: Additional scan time on standard MR angiography

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Hemodynamic Analysis Of Intracranial Artery And Associated Lesions Using 2-D/3D Phase Contrast MR Angiography Focused On Wall Shear Stress Measurement

Resource links provided by NLM:


Further study details as provided by Lahey Clinic:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Develope predictor to identify risk factors of possible future aneurysm rupture and SAH [ Time Frame: Duration of MRA test ] [ Designated as safety issue: Yes ]

Enrollment: 0
Study Start Date: March 2008
Study Completion Date: December 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
2D/3D Phase contrast MR 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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00710281

Locations
United States, Massachusetts
Lahey Clinic, Inc.
Burlington, Massachusetts, United States, 01805
Sponsors and Collaborators
Lahey Clinic
VasSol®-Nova Software
Investigators
Principal Investigator: Seon Kyu Lee, M.D., Ph.D. Lahey Clinic, Inc.
  More Information

Publications:
Responsible Party: Lahey Clinic
ClinicalTrials.gov Identifier: NCT00710281     History of Changes
Other Study ID Numbers: 2008-020
Study First Received: July 1, 2008
Last Updated: September 17, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Lahey Clinic:
Intracranial Aneurysm
Subarachnoid arterial aneurysm
Aneurysm
Brain Aneurysm
Cerebral Aneurysm
Wall Shear Stress(WSS)
Hemodynamic Stress
Subarachnoid Hemorrhage(SAH)

Additional relevant MeSH terms:
Aneurysm
Intracranial Aneurysm
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on April 17, 2014