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临床试验/NCT03030521
NCT03030521已完成不适用

The Roles of Intraluminal Pressure and the Dilation of Tunica Media in the Development of Aortic Dissection

Wuhan Asia Heart Hospital1 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2017年1月30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
8
试验地点
1
主要终点
The number of patients with a positive result of the aortic delamination test

研究概览

简要总结

Aortic dissection is defined as the separation of aortic medial lamellae. It is unknown why some aortic dissection are limited in extent while other aortic dissection extend extensively. The investigators hypothesize that the medial layers are separated as a result of the uneven dilation and dislocation of the inner and outer layers, and if this hypothesis is ture, dilation is necessary to the development of aortic dissection. In this study, an in vitro experiment was performed to test whether dilation is essential to the development of aortic dissection.

Participants will be recruited from patients with aortic repair surgery in Wuhan Asian Heart Hospital. A piece of aortic wall will be dissected to reconstruct aorta during operation. Firstly, the dissected aortic wall is sampled for routine pathological examination. Secondly, the remaining tissue is cut into a 2cm by 2cm sheet, then an incision was made on the inner surface of the tissue sheet. The outer 0.5mm media will not be incised. Thirdly, the tissue sheet is used to seal a hole in a syringe with the incision faced inside, and tissue sheet of the experimental group was bound by a band to restrict its dilation in the next step. Fourthly, the syringe is filled with blue stain, and a mechanical test is performed. Fifthly, for the experimental group, the band is removed, and the syringe is filled with red stain. The mechanical test is performed again. Finally, the tissue sheet is released and cut into several parts to show whether the inner and outer media layers are separated by the blue stain or the red stain.

详细描述

The mechanical test: the syringe's pressure will increase gradually to a target level, and then decrease gradually to 0 Mpa, and this process is repeated for about 60 times.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients with aortic repair surgery.

排除标准

  • the dissected aortic wall is not big enough to be cut into a 2cm by 2cm sheet after routine pathological examination.

结局指标

主要结局

The number of patients with a positive result of the aortic delamination test

时间窗: 1 month

whether the inner and outer media layers are separated by the blue stain or the red stain.

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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