Estrogen Exposure and Atherosclerosis in Postmenopausal Women

NCT02951949 | Completed DMC

• 1 other identifier: Ayudas Fundación Eresa 2008
• Study Type: observational
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

One hundred Spanish postmenopausal women accepted to be investigated for cardiovascular risk actors including clinical features, serum biochemical parameters, single nucleotide polymorphisms for estrogen receptor, and imaging parameters, carotid intima-media thickness (91 women) and coronary computed tomography (32 women). Multivariable analysis confirmed that both age and glucose level directly affected IMT. Estrogenic exposure, as measured by the allele associated with lower expression of the ER beta gene, was protective at the sinus and the wall. Findings at the coronary arteries, either moderate or high calcium index (CAC) and/or significant lumen stenosis were sporadic and did not allow for establishing association with any of the variables assessed.

Conditions

Atherosclerosis; Menopause; Estrogens; Carotid Intima-media Thickness; Coronary Stenoses; Women

Keywords

atherosclerosis, endogenous estrogens, age

Outcome Measures

Primary Outcomes (1)

• Carotid intima-media thickness.

  Postmenopausal women attending clinical service for health control were measured carotid intima-media thickness by ultrasound.

  12 weeks

Secondary Outcomes (2)

• Changes in coronary calcium score.

  12 weeks

• Changes in coronary lumen stenosis.

  12 weeks

Study Arms (1)

Postmenopausal women

Postmenopausal women attending the outpatient service of a third level hospital for health control.

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Postmenopausal women attending a clinical outpatient service in a third-level hospital for health control.

You may qualify if:

• Postmenopausal women free of previous diagnosis of cardiovascular disease, Caucasian ethnicity, urban origin, medium or medium-low socioeconomic extraction.

You may not qualify if:

• Previous diagnosis of cardiovascular disease, inability to understand the purpose and conditions of the study..

Sponsors & Collaborators

• University of Valencia: lead

Study Sites (1)

Hospital Clínico Universitario

Valencia, 46010, Spain

Location

MeSH Terms

Conditions

Atherosclerosis; Coronary Stenosis

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Coronary Disease; Myocardial Ischemia; Heart Diseases

Study Officials

• Antonio Cano, MD

  University of Valencia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor Obstetrics and Gynecology

Study Record Dates

• First Submitted: October 23, 2016
• First Posted: November 1, 2016
• Study Start: November 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: December 1, 2015
• Last Updated: April 7, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)