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临床试验/NCT03474159
NCT03474159已完成不适用

Evaluation of Aortic Stiffness as a Prognostic Indicator of Aortic Dilatation in Patients With Bicuspid Aortic Valve (BAV) by Multimodal Imaging (MRI, Echocardiography and Ultrafast Ultrasound Imaging)

French Cardiology Society2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2018年11月7日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
2
主要终点
Evaluation of the progression of artic dilation with MRI

研究概览

简要总结

The objective is the development and validation of morphological markers informative of aortic dilatation in order to improve the precision of the risk of aneurysm of the thoracic aorta and of acute aortic syndrome for patients with bicuspid aortic valve (BAV).

The primary objective of this study is to demonstrate a correlation between the aortic local pulse wave velocity (PWV) measured with MRI and the progression of the thoracic aorta diameters measured by MRI after a follow-up of 2 years.

详细描述

Background Bicuspid Aortic Valve (BAV) is the most common congenital heart defect with prevalence around 1 to 2% of the general population . It is defined by the presence of two functional cusps with less than three parallel zones of apposition between the cusps. This different valve's morphology is associated with a spectrum of valvular (aortic stenosis and insufficiency) and aortic complications (aneurysm and dissection). Indeed, the valvular abnormality is associated with changes in the aortic arch with an increase in the incidence of ascending aortic aneurysm unrelated to valvular functional impairment. The mechanisms responsible for aortic involvement are still incompletely understood but combine, in varying proportions, a constitutional fragility (linked to a common embryological origin of the aortic valve and the aortic arch) and to the haemodynamic modifications, generated by the specific morphology of BAV .

Current risk prediction of aneurysm development is currently performed only with the ascending aortic diameter, associated with history of aortic coarctation and familial history of dissection. Moreover, aortic dilatation may occur after aortic valve replacement alone, necessitating a second intervention, with a higher surgical risk. Improvement of the aortopathy evaluation is therefore a major stake in the evaluation of the BAV patient.

Studies of the biomechanical properties of the BAV aortic wall converge towards an increase in arterial stiffness as well as in other elastopathies such as Marfan's disease. Thus, measurements of aortic distensibility in trans-thoracic echocardiography (TTE) or MRI, or the measurement of the Pulse Wave Velocity (PWV) are significantly different case of BAV compared to the general population. However, no prospective study has demonstrated the prognostic role of these morphological biomarkers in the prediction of aortic dilation.

From a biomechanical point of view, the vessel's rupture appears when the mechanical stress applied to the wall exceeds the material resistance properties. The aortic resistance evaluation requires the use of different imaging modalities which propose the measurement of stiffness parameters. Circumferential stiffness (with TTE or MRI) can be evaluated by measuring the distensibility. In addition, longitudinal stiffness can be evaluated by measuring the local PWV.

We aim at better defining the vascular involvement of BAV patients by determining the prognostic role of functional parameters as non-invasive predictive factors for aortic dilation.

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

  • Adults over 18 years of age,
  • confirmed BAV by TTE computed tomography or MRI.
  • Adults benefiting from a social security scheme,
  • having received information on the research
  • having signed the consent form

排除标准

  • Patient with a syndromic form of BAV:
  • Loeys-Dietz syndrome,
  • Turner syndrome
  • Williams-Beuren syndrome
  • Shone syndrome

结局指标

主要结局

Evaluation of the progression of artic dilation with MRI

时间窗: For each patient, inclusion in the study will be associated with one-day hospitalization with: MRI (=first MRI), TTE and UF (at T0). Patients will then be re-examined after 2 years to perform a second MRI to assess aortic dilatation (T=2 years).

The measure evaluates a change, which is why there is more than one time point. For patients, a first MRI and a second MRI will be performed after 2 years (+/- 2 months) in order to evaluate prospectively the progression of aortic dilatation according to stiffness parameters.

次要结局

  • Comparison of aortic stiffness evaluation with different methods TTE, MRI, UF(For each patient, inclusion in the study will be associated with one-day hospitalization with: MRI (=first MRI), TTE and UF (at T0). Patients will then be re-examined after 2 years to perform a second MRI to assess aortic dilatation (T=2 years).)

研究者

发起方
French Cardiology Society
申办方类型
Other
责任方
Sponsor

研究点 (2)

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