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

Intracranial Arterial Aneurysm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00710281
• Other study ID #: 2008-020
• Status: Withdrawn
• Phase: N/A
• First received: July 1, 2008
• Last updated: September 17, 2013
• Start date: March 2008
• Est. completion date: December 2011

Study information

• Verified date: September 2013
• Source: Lahey Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Aneurysm
• Intracranial Arterial Aneurysm

Intervention

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:

Locations

Country	Name	City	State
United States	Lahey Clinic, Inc.	Burlington	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Lahey Clinic	VasSol®-Nova Software

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. Epub 2005 May 12. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identify, measure and map the Wall Shear Stress (WSS) measurements and affects in subarachnoid aneurysm developement.		Duration of the MRA test	Yes
Secondary	Develope predictor to identify risk factors of possible future aneurysm rupture and SAH		Duration of MRA test	Yes