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临床试验/NCT02060071
NCT02060071Unknown4 期

Endothelial Progenitors in Aortic Stenosis: Association With Aortic Stenosis Progression, Severity, Symptoms and Left Ventricular Function Assessed by 2D Strain Echocardiography

Kaplan Medical Center2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2011年7月1日最近更新:
适应症

试验速览

阶段
4 期
发起方
入组人数
200
试验地点
2
主要终点
Cardiac death or need for intervantion in correlation to endothelial progenitor cells

研究概览

简要总结

There is a correlation between endothelial progenitor cells (stem cells) and stenosis of the aortic valve.

详细描述

Degenerative aortic valve (AV) stenosis (AS) is the most common valvular disease and increases in prevalence with age. Severe aortic valve stenosis accounts for considerable disease and death, especially in older patients. Aortic valve stenosis is the primary indication for valve replacement in western countries, and the number will only increase as elderly people are a growing subpopulation. Measures to identify AV disease earlier, to identify factors that influence disease progression and treat AV disease pharmacologically or with less invasive approaches would be a significant improvement over the current standard of care. These advances will only be possible with a better understanding the mechanisms underlying valve development and disease. Preliminary data suggest a novel pathophysiological concept for impaired valvular endothelial cells regeneration, leading to the progression of age-associated calcific AV disease and a potential treatment target is the disrupted endothelial cell layer of the valve leaflet.

The research objectives are:

  1. To assess the number and function of endothelial progenitor cellss and apoptotic endothelial progenitor cellss in patients with mild, moderate and severe aortic stenosis.
  2. To study the association between aortic stenosis progression, severity, symptoms and left ventricular function and the number and function of circulating endothelia progenitor cells. By understanding the correlation between valve severity, left ventricular longitudinal function and endothelial progenitor cells we will indentify high risk patients population that need early intervention. We hope to add new information on the pathogenesis of aortic stenosis and to indentify factors that predict disease progression.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 92 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with Aortic stenosis
  • Control with aortic stenosis

排除标准

  • 未提供

结局指标

主要结局

Cardiac death or need for intervantion in correlation to endothelial progenitor cells

时间窗: 4 years

We will assess wether endothelial progenitor cells can predict outcome

次要结局

未报告次要终点

研究者

发起方
Kaplan Medical Center
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sara Shimoni

MD, Director of non Invasive Cardiology Unit

Kaplan Medical Center

研究点 (2)

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