Peripheral Artery Disease Clinical Trial
— ESTROPADOfficial title:
Molecular Analysis of Estrogen Receptors in Patients With Peripheral Artery Disease
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.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | November 2, 2020 |
Est. primary completion date | September 1, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients with peripheral artery disease (PAD) eligible to receive arterial reconstructive open surgery. Exclusion Criteria: - malignancy - estrogen therapy |
Country | Name | City | State |
---|---|---|---|
Italy | CIFL- Interuniversity Center of Phlebolymphology | Catanzaro |
Lead Sponsor | Collaborator |
---|---|
University of Catanzaro |
Italy,
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. Review. — View Citation
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. Review. — View Citation
Criqui MH, Aboyans V. Epidemiology of peripheral artery disease. Circ Res. 2015 Apr 24;116(9):1509-26. doi: 10.1161/CIRCRESAHA.116.303849. Review. Erratum in: Circ Res. 2015 Jun 19;117(1):e12. — View Citation
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. — View Citation
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. Epub 2005 Aug 30. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
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