Estrogen Receptors and Peripheral Artery Disease

NCT ID: NCT04419727

Last Updated: 2020-06-05

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-01-02
• Study Completion Date: 2020-11-02

Brief Summary

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

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.

Conditions

Estrogen Deficiency; Peripheral Artery Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• malignancy
• estrogen therapy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Catanzaro

OTHER

Sponsor Role: lead

Responsible Party

Prof. Raffaele Serra, MD, Ph.D.

Associate Professor of Vascular Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

University Magna Graecia of Catanzaro

Locations

CIFL- Interuniversity Center of Phlebolymphology

Catanzaro, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

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

Role: CONTACT

rserra@unicz.it

+3909613647380

Facility Contacts

Raffaele Serra, MD

Role: primary

rserra@unicz.it

+393387078043

References

Criqui MH, Aboyans V. Epidemiology of peripheral artery disease. Circ Res. 2015 Apr 24;116(9):1509-26. doi: 10.1161/CIRCRESAHA.116.303849.

Reference Type: BACKGROUND

PMID: 25908725 (View on PubMed)

Serra R, Gallelli L, Perri P, De Francesco EM, Rigiracciolo DC, Mastroroberto P, Maggiolini M, de Franciscis S. Estrogen Receptors and Chronic Venous Disease. Eur J Vasc Endovasc Surg. 2016 Jul;52(1):114-8. doi: 10.1016/j.ejvs.2016.04.020. Epub 2016 May 21.

Reference Type: BACKGROUND

PMID: 27220899 (View on PubMed)

Barton M, Prossnitz ER. Emerging roles of GPER in diabetes and atherosclerosis. Trends Endocrinol Metab. 2015 Apr;26(4):185-92. doi: 10.1016/j.tem.2015.02.003. Epub 2015 Mar 9.

Reference Type: BACKGROUND

PMID: 25767029 (View on PubMed)

Boese AC, Kim SC, Yin KJ, Lee JP, Hamblin MH. Sex differences in vascular physiology and pathophysiology: estrogen and androgen signaling in health and disease. Am J Physiol Heart Circ Physiol. 2017 Sep 1;313(3):H524-H545. doi: 10.1152/ajpheart.00217.2016. Epub 2017 Jun 16.

Reference Type: BACKGROUND

PMID: 28626075 (View on PubMed)

Kublickiene K, Svedas E, Landgren BM, Crisby M, Nahar N, Nisell H, Poston L. Small artery endothelial dysfunction in postmenopausal women: in vitro function, morphology, and modification by estrogen and selective estrogen receptor modulators. J Clin Endocrinol Metab. 2005 Nov;90(11):6113-22. doi: 10.1210/jc.2005-0419. Epub 2005 Aug 30.

Reference Type: BACKGROUND

PMID: 16131583 (View on PubMed)

Kalicinska E, Wojtas K, Majda J, Zacharski M, Skiba J, Sliwowski J, Banasiak W, Ponikowski P, Jankowska EA. Expression of sex steroid receptors and aromatase in adipose tissue in different body regions in men with coronary artery disease with and without ischemic systolic heart failure. Aging Male. 2020 Jun;23(2):141-153. doi: 10.1080/13685538.2018.1494144. Epub 2018 Sep 7.

Reference Type: BACKGROUND

PMID: 30193537 (View on PubMed)

Other Identifiers

ER.ALL.2018.31

Identifier Type: -

Identifier Source: org_study_id