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Estrogen Receptors and Chronic Venous Disease (ERCVD)

U

University of Catanzaro

Status

Completed

Conditions

Estrogen Excess
Varicose Veins

Treatments

Procedure: Venous Surgery

Study type

Observational

Funder types

Other

Identifiers

NCT02558426
ER.ALL.2013.31

Details and patient eligibility

About

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.

Full description

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.

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.

Although ERs are also suspected to be involved in the underlying etiology, the exact molecular mechanism responsible for development of CVD as well as the relationship with the wide range of clinical manifestations of CVD remains to be elucidated and the aim of this study is to explore the expression of estrogen receptors in vessel wall of varicose veins collected from patients with varicose veins through the entire clinical spectrum of CVD.

Enrollment

40 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • Concomitant Peripheral Artery Disease
  • Previous Venous Thromboembolism

Trial design

40 participants in 1 patient group

CVD patients
Description:
Patients with CVD at various stages (C2-C6 of CEAP classification of CVD) with varicose veins and eligible to receive Open Venous Surgery.
Treatment:
Procedure: Venous Surgery

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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