AzTrials
AzTrials

Estrogen DeficiencyESTROPADNCT04419727

Estrogen Receptors and Peripheral Artery Disease

An observational study of Estrogen Deficiency and Peripheral Artery Disease, run by University of Catanzaro at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
arterial reconstructive open surgery
Type of treatment
Surgery or procedure
How many people
40 participants
Where
1 siteItaly
Study dates
2 Jan 2020to 2 Nov 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with peripheral artery disease (PAD) eligible to receive arterial reconstructive open surgery

Who may be able to join

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

Who cannot join

  • malignancy
  • estrogen therapy

Trial locations and contacts

1 site in 1 country.

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

+3909613647380

rserra@unicz.it

Italy1 site, 1 recruiting

  • CIFL- Interuniversity Center of Phlebolymphology

    Catanzaro, 88100

    Raffaele Serra, MD, +393387078043, rserra@unicz.it

    Recruiting

Other trials in Italy

About this study

Official 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.

Read the 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.

Being tested
arterial reconstructive open surgery
Keywords
Peripheral artery disease, Estrogens receptors, GPER
Medical subject headings
Peripheral Arterial Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • arterial reconstructive open surgeryProcedure or 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 being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: at month 6th

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jun 2020
  2. Study start2 Jan 2020
  3. Primary completion1 Sep 2020 (estimated)
  4. Study completion2 Nov 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04419727
Sponsor's protocol ID
ER.ALL.2018.31
Acronym
ESTROPAD
Status last verified
Jun 2020
First submitted
3 Jun 2020
Last updated
5 Jun 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

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

    PubMed 25908725

  • 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.

    PubMed 27220899

  • 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.

    PubMed 25767029

  • 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.

    PubMed 28626075

  • 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.

    PubMed 16131583

  • 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.

    PubMed 30193537

Questions about this trial

What is this clinical trial studying?

An observational study of Estrogen Deficiency and Peripheral Artery Disease, run by University of Catanzaro at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 5 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Raffaele Serra, M.D., Ph.D. (+3909613647380, rserra@unicz.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Expression of ER-alpha, ER-beta,and GPER (time frame: at month 6th). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04419727, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in