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临床试验/NCT02558426
NCT02558426已完成不适用

Molecular Analysis of Estrogen Receptors in Patients With Chronic Venous Disease

University of Catanzaro0 个研究点目标入组 40 人开始时间: 2015年1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
40
主要终点
expression of ERα, ERβ and GPER

研究概览

简要总结

Chronic Venous Disease (CVD) is a very common problem affecting western adult population. To date the pathophysiology of CVD development encloses several theories such as the role of extracellular matrix (ECM) components alterations, the alteration of Matrix Metalloproteinases (MMPs) and other related molecules, the endothelial dysfunction, and several genetic factors but none of these could properly explain its genesis. Estrogen Receptors may be involved in CDV pathogenesis. Endogenous estrogens are important regulators of vascular homeostasis and they act mainly via three different ERs which are expressed in the cardiovascular system: ERα, ERβ, and a G protein-coupled estrogen receptor termed GPER. of this study is to explore the expression of estrogen receptors in vessel wall of varicose veins through the entire clinical spectrum of CVD.

详细描述

Chronic Venous Disease (CVD) is a very common problem affecting western adult population with a prevalence of < 10%, among individuals younger than 30 years for both sex, and with a prevalence of 57% and 77%, in men and women aged ≥ 70 years respectively, and may be frequently associated with other clinical manifestations.

The spectrum of CVD ranges from varicose veins to leg edema, and serious dermal clinical manifestations consisting of hyperpigmentation, eczema, lipodermatosclerosis, and venous skin ulceration.

To date the pathophysiology of CVD development encloses several theories such as the role of extracellular matrix (ECM) components alterations, the alteration of Matrix Metalloproteinases (MMPs) and other related molecules, the endothelial dysfunction, and several genetic factors but none of these could properly explain its genesis.

A recent study (Serra R et al) showed a higher prevalence of CVD among patients with Breast Cancer (BC) respect to general population, especially in those patients that were positive to estrogen receptor (ER) expression.

The presence of ERs was investigated in the walls of normal and varicose veins by Mashiah A. et al, previously, and they documented that increased concentrations of estrogen receptors were found in varicose vein segments respect to healthy controls and this was particularly evident in females.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with Chronic Venous Disease and varicose veins eligible to receive open venous surgery procedure

排除标准

  • Concomitant Peripheral Artery Disease
  • Previous Venous Thromboembolism

结局指标

主要结局

expression of ERα, ERβ and GPER

时间窗: At month 9th

The expression of ERα, ERβ and GPER will be quantified by real-time PCR using the Step OneTM sequence detection system (Applied Biosystems Inc., Milan, Italy), following the manufacturer's instructions

次要结局

未报告次要终点

研究者

发起方
University of Catanzaro
申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. Raffaele Serra, MD, Ph.D.

Assistant Professor of Surgery

University of Catanzaro

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