Analysis Of Intracranial Artery Lesions Using 2-D/3D Phase Contrast MR
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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 |
- 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 ]
- 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: | 7 |
| 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:
|
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 |
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| United States, Massachusetts | |
| Lahey Clinic, Inc. | |
| Burlington, Massachusetts, United States, 01805 | |
| 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: | May 8, 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 May 21, 2013