Estrogen Receptors and Peripheral Artery Disease

Study Overview
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Brief Summary
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It is estimated that >200 million people have Peripheral artery disease (PAD) worldwide. PAD is related to increased morbidity or mortality in affected patients. More severe forms of PAD are surgically managed. Estrogen receptors (ERs) are strictly linked with vascular disease, and may be involved also in PAD onset and progression. This study will explore the expression of ERs, (ER-alpha, ER-beta,and a G protein-coupled of estrogen receptor -GPER-) in vessel wall of arteries of operated PAD patients, through the entire clinical spectrum of PAD.

Detailed Description
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PAD is the atherosclerotic obstruction of the arteries of the lower extremities and it is widespread especially in highly developed countries. The most common complication of PAD is critical limb ischemia with rest pain and leg ulcers. To date the pathophysiology of PAD is linked to atherosclerosis but other pathways are also under evaluation. A recent study (Serra et al) investigated the presence of ER-alfa, ER-beta, and GPER in the wall of normal and varicose veins. The aim of this observational study is to evaluate the expression and the role of estrogen receptors in patients with PAD, and undergoing surgical treatment with reconstructive arterial surgery. Therefore, we will collect tissue samples from diseased arteries that will be further analyzed for ER expression. We will then correlate the results with the clinical spectrum of the patients.

Official Title
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Molecular Analysis of Estrogen Receptors in Patients With Peripheral Artery Disease

Conditions
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Estrogen Deficiency, Peripheral Artery Disease

Intervention / Treatment
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* Procedure: arterial reconstructive open surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with peripheral artery disease (PAD) eligible to receive arterial reconstructive open surgery. Exclusion Criteria: malignancy estrogen therapy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: arterial reconstructive open surgery|Patients with peripheral artery disease (PAD) will undergo arterial reconstructive open surgery. Samples obtained from diseased arteries of lower limbs of patients undergoing arterial reconstructive open surgery will be collected and immediately preserved at -80°. Briefly, the arterial tissues will be excised, homogenized with a motor-driven homogenizer and total RNA will be isolated using Trizol reagent (Invitrogen, Milan Italy), according to the manufacturer's instructions. The expression of ER-alpha, ER-beta,and GPER will be quantified by real-time PCR using the Step One ™ sequence detection system (Applied Biosystems Inc. Milan, Italy), following the manufacturer's instruction|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Expression of ER-alpha, ER-beta,and GPER | The expression of ER-alpha, ER-beta,and GPER will be quantified by real-tome PCR using Step One ™ sequence detection system (Applied Biosystems Inc. Milan, Italy) following the manufacturer's instruction | at month 6th | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peripheral artery disease, Estrogens receptors, GPER