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Estrogen Receptors and Chronic Venous Disease

Molecular Analysis of Estrogen Receptors in Patients With Chronic Venous Disease

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02558426
Acronym
ERCVD
Enrollment
40
Registered
2015-09-24
Start date
2015-01-31
Completion date
2015-09-30
Last updated
2015-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Estrogen Excess, Varicose Veins

Keywords

Chronic Venous Disease, Estrogen receptors, GPER

Brief summary

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.

Detailed 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.

Interventions

PROCEDUREVenous Surgery

Patients with Varicose Veins will undergo to venous surgery procedure. Samples obtained from patients undergoing surgical removal of varicose veins will be collected and immediately preserved at -80°. Briefly, the venous tissueswill be excised, homogenized with a motor-driven homogenizer and total RNA will be isolated using the Trizol reagent (Invitrogen, Milan, Italy), according to the manufacturer's instructions. 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

Sponsors

University of Catanzaro
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
expression of ERα, ERβ and GPERAt month 9thThe 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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026