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临床试验/NCT02860182
NCT02860182Unknown不适用

Mechanical Characterization of Ascending Aorta in Patients With Acute Type A Dissection and in Healthy Control Group Combined to Structural and Ultrastructural Analysis of Aortic Tissue

Assistance Publique Hopitaux De Marseille1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2014年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
90
试验地点
1
主要终点
measure the elastic properties of aortic wall

研究概览

简要总结

Acute type A aortic dissection is a frequent (3 cases per 100 000 people per year) and severe (spontaneous mortality 70%), needing an emergency surgical treatment. Surgical outcomes have improved with the development of surgical techniques, but the postoperative mortality remains high (15-30% at 30 days). Endovascular approach with the deployment of endoprosthesis sealing the proximal intimal tear is an attractive minimally invasive technique, which can represent an alternative to surgical repair especially in high risk patients.

详细描述

Objectives: this study aims to characterize mechanical properties of ascending aorta (AA) in patients, with and without aortic dissection.

Materials and methods : comprised an in vivo and ex vivo studies performed in 2 groups of patients : (1) patients admitted for acute type A dissection and treated with surgical procedure ; (2) healthy control group selected among patients without any ascending aorta pathology and who underwent transoesophageal echocardiography for various indications.

In vivo study : Strain, distensibility, stiffness index and pressure strain elastic modulus (Ep) were calculated from aortic diameter variation in response to pressure variation. Aortic diameters were measured using transoesophageal echocardiography.

Ex vivo study : biaxial tensile testing were performed on aortic wall samples. Dissected aortic samples were collected from patients who underwent surgical repair and healthy samples from unused donors hearts and lungs. Mechanical characterization was combined to a histological and microstructural analysis of aortic wall. The latter was conducted using multiphoton microscopy to visualize elastin and collagen fibers.

Results :

研究设计

研究类型
Observational
时间视角
Prospective

入排标准

年龄范围
50 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged 50 to 85 years
  • The information given search,
  • Aortic dissection evolving for less than 15 days confirmed

排除标准

  • the acute aortic dissections against-indicated for aortic surgery (patient age, stroke or multiple organ failure)
  • Iatrogenic dissections,
  • Dissections related to congenital or hereditary disorder (abnormal connective tissue) or those occurring in subjects with a bicuspid aortic valve,
  • Intramural hematomas type A,
  • Patients under guardianship or trusteeship deprived of liberty.

结局指标

主要结局

measure the elastic properties of aortic wall

时间窗: one day

The distensibility, aortic strain will be measured as a function of changes of aortic diameter and pulse pressure.

Measurement of aortic diameters

时间窗: one day

The measurement will be done by transesophageal echocardiography simultaneously to the cuff brachial artery pressure.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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