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临床试验/NCT00710281
NCT00710281撤回不适用

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

Lahey Clinic2 个研究点 分布在 1 个国家开始时间: 2008年3月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
Lahey Clinic
试验地点
2
主要终点
Identify, measure and map the Wall Shear Stress (WSS) measurements and affects in subarachnoid aneurysm developement.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Unruptured and ruptured adult (>18 years) intracranial arterial aneurysm patients

排除标准

  • 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.

结局指标

主要结局

Identify, measure and map the Wall Shear Stress (WSS) measurements and affects in subarachnoid aneurysm developement.

时间窗: Duration of the MRA test

次要结局

  • Develope predictor to identify risk factors of possible future aneurysm rupture and SAH(Duration of MRA test)

研究者

发起方
Lahey Clinic
申办方类型
Other
责任方
Sponsor

研究点 (2)

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