Estrogen Receptors and Peripheral Artery Disease
ESTROPAD
Molecular Analysis of Estrogen Receptors in Patients With Peripheral Artery Disease
1 other identifier
observational
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2020
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 2, 2020
CompletedFirst Submitted
Initial submission to the registry
June 3, 2020
CompletedFirst Posted
Study publicly available on registry
June 5, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 2, 2020
CompletedJune 5, 2020
June 1, 2020
8 months
June 3, 2020
June 3, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Interventions
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
Eligibility Criteria
Patients with peripheral artery disease (PAD) eligible to receive arterial reconstructive open surgery
You may qualify if:
- Patients with peripheral artery disease (PAD) eligible to receive arterial reconstructive open surgery.
You may not qualify if:
- malignancy
- estrogen therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CIFL- Interuniversity Center of Phlebolymphology
Catanzaro, 88100, Italy
Related Publications (6)
Criqui MH, Aboyans V. Epidemiology of peripheral artery disease. Circ Res. 2015 Apr 24;116(9):1509-26. doi: 10.1161/CIRCRESAHA.116.303849.
PMID: 25908725BACKGROUNDSerra 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.
PMID: 27220899BACKGROUNDBarton 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.
PMID: 25767029BACKGROUNDBoese 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.
PMID: 28626075BACKGROUNDKublickiene 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.
PMID: 16131583BACKGROUNDKalicinska 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.
PMID: 30193537BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Raffaele Serra, M.D., Ph.D.
University Magna Graecia of Catanzaro
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Vascular Surgery
Study Record Dates
First Submitted
June 3, 2020
First Posted
June 5, 2020
Study Start
January 2, 2020
Primary Completion
September 1, 2020
Study Completion
November 2, 2020
Last Updated
June 5, 2020
Record last verified: 2020-06
Data Sharing
- IPD Sharing
- Will not share