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临床试验/NCT03172390
NCT03172390已完成不适用

In Vivo Evaluation of Growth and Risk of Rupture of Dilated Ascending Aorta Using 4D Cardiac Magnetic Resonance

Centre Hospitalier Universitaire de Saint Etienne2 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2017年10月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
41
试验地点
2
主要终点
Correlation between wall shear stress (WSS) and aorta diameter in patient with dilated ascending aorta

研究概览

简要总结

Ascending aorta aneurysmal disease is common and can be complicated by dissection or rupture. There is substantial variation in individual aneurysm progression: established risk factors for an accelerated aneurysm growth rate include initial size or localization, the presence of aortic valve disease, congenital bicuspid aortic valve or connective tissue disorders.

详细描述

Although there is an increased lifetime risk when the aortic diameter exceeds 6 cm, predicting aneurysm progression is nearly impossible and dissection and rupture also occur at diameters under 6 cm. The assessment of aortic hemodynamics and the presence of altered flow patterns, as well as distribution and changes in wall shear stress (WSS) and the oscillatory shear index (OSI), using 4D phase contrast cardiovascular magnetic resonance (CMR) may provide further insights in how aneurysms develop and in assessing the risk of dissection. The purpose of this study was to investigate in patients with dilated ascending aorta the flow patterns and vessel wall parameters in order to correlate these hemodynamics factors with changes in aorta size.

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

  • Age ≥ 18 years.
  • Supra-coronary aortic diameter measured by CT-scan or transthoracic/trans-esophageal echocardiography between 40 and 45 mm in case of presence of aortic valve disease, bicuspid aortic valve or connective tissue disease and between 40 and 50 mm in case of absence of aortic valve disease, bicuspid aortic valve disease or connective tissue.
  • Informed consent for participation in the study

排除标准

  • Contraindication to MRI
  • Patient's refusal to participate in the study and / or inability to express agreement or signing the informed consent.

结局指标

主要结局

Correlation between wall shear stress (WSS) and aorta diameter in patient with dilated ascending aorta

时间窗: From baseline to 1 year

Aorta diameter \[mm\] is assessed by 4D phase contrast cardiovascular magnetic resonance (CMR) Wall shear stress (WSS) in aorta \[Pa\] is assessed by 4D phase contrast cardiovascular magnetic resonance (CMR).

次要结局

  • Aorta parameters associated with change in aorta diameter(From baseline to 1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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