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临床试验/NCT01993485
NCT01993485已完成不适用

The Effect of Transaortic Valve Replacement on the Endothelial Integrity and Function

Heinrich-Heine University, Duesseldorf1 个研究点 分布在 1 个国家实际入组 61 人开始时间: 2013年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
61
试验地点
1
主要终点
endothelial function

研究概览

简要总结

Degenerative aortic valve stenosis (AVS) is the leading cause of aortic valve morbidity with a prevalence of 2-7% at ages above 65 years, with ever-increasing incidence especially in the 8th decades. AVS is independently associated with atheroclerosis risk factors and clinically apparent CV disease indicating that the degeneration of the aortic valve may represent an atheroclerosis-like process involving both, the aortic valve as well as the vascular system, respectivel. It is still unknown whether the endothelial function is affected as an manifestation of the atherosclerotic process, changes in the driving mechanical forces as WSS downstream of the valve, or other factors beyond physical pressure effects.

The investigators hypothesized that altered haemodynamics may at least partly be responsible for observed endothelial dysfunction in patients with AVS. Therefore, the aim of this study is to investigate whether the resolution of AVS by transaortic valve implacement (TAVI) affects WSS, improves endothelial dysfunction and decreases levels of circulating EMPs as markers of endothelial integrity.

研究设计

研究类型
观察性
观察模型
队列研究
时间视角
前瞻性

入排标准

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

入选标准

  • aortic valve stenosis
  • screened for TAVI
  • written informed consent

排除标准

  • no written informed consent
  • Patients with acute infections (CRP> 0.5 mg / dL)
  • Patients with Atrial Fibrillation
  • Patients with inflammatory and malignant diseases

结局指标

主要结局

endothelial function

时间窗: Changes from Baseline in endothelial function at 3 months

endothelial function will be measured by flow mediated dilation (FMD)

plasma levels of circulating microparticles (MPs)

时间窗: Changes from Baseline in Plasma Levels of MPs at 3 months

次要结局

  • arterial stiffness(Changes from Baseline in arterial stiffness at 3 months)
  • blood pressure(Changes from Baseline in Hemodynamics at 3 months)
  • heart rate(Changes from Baseline in Hemodynamics at 3 months)

研究者

发起方
Heinrich-Heine University, Duesseldorf
申办方类型
其他
责任方
主要研究者
主要研究者

Klinik für Kardiologie, Pneumologie und Angiologie

Division of Cardiology, Pulmonary Diseases, Vascular Medicine

Heinrich-Heine University, Duesseldorf

研究点 (1)

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标识符

NCT 编号
NCT01993485
其他研究编号
MP TAVI

日期

首次提交
(12年前)
首次发布
(12年前)
主要完成日期
研究完成日期
最近核实
最近更新
(12年前)

监管与共享

FDA 监管药物
否
是否有结果
否

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