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Estrogen Receptors and Peripheral Artery Disease (ESTROPAD)

U

University of Catanzaro

Status

Unknown

Conditions

Peripheral Artery Disease
Estrogen Deficiency

Treatments

Procedure: arterial reconstructive open surgery

Study type

Observational

Funder types

Other

Identifiers

NCT04419727
ER.ALL.2018.31

Details and patient eligibility

About

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.

Full description

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.

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients with peripheral artery disease (PAD) eligible to receive arterial reconstructive open surgery.

Exclusion criteria

  • malignancy
  • estrogen therapy

Trial contacts and locations

1

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Central trial contact

Raffaele Serra, M.D., Ph.D.

Data sourced from clinicaltrials.gov

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