Estrogen Exposure and Atherosclerosis in Postmenopausal Women

Completed

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

• Registration Number: NCT02951949
• Lead Sponsor: University of Valencia

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.

Detailed Description

One hundred postmenopausal women living in the urban area of Valencia were invited to participate in a cross-sectional study in which a list of clinical and analytical risk factors for cardiovascular disease were assessed. Clinical factors included weight, waist circumference, body mass index and blood pressure. Analytical parameters included lipidogram, serum glucose and insulin, thyroid hormones (TSH and total T4), vitamin D, ultra-sensitive C-reactive protein, estradiol, and osteoprotegerin. Imaging studies were performed to identify the atherosclerotic burden at the carotid artery (intima-media thickness, measured by a high frequency ultrasound probe), and the coronaries (both coronary artery calcium(CAC) score and the degree of lumen stenosis). Genetic susceptibility was measured by studying single nucleotide polymorphisms of the estrogen receptor. The independent effect of each variable was analyzed with multivariate analysis.

Study Timeline

• Study Start: 2014-11
• Primary Completion: 2015-07
• Study Completion: 2015-12
• Study First Submitted: 2016-10-23
• Study First Submitted QC: 2016-10-30
• Study First Posted: 2016-11-01
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-03
• Last Update Posted: 2020-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 92

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Carotid intima-media thickness.	12 weeks	Postmenopausal women attending clinical service for health control were measured carotid intima-media thickness by ultrasound.

Secondary Outcome Measures

Name	Time	Method
Changes in coronary calcium score.	12 weeks	Postmenopausal women attending clinical service for health control were measured the coronary calcium score with computed tomography.
Changes in coronary lumen stenosis.	12 weeks	Postmenopausal women attending clinical service for health control were measured the coronary lumen stenosis with computed tomography.

Trial Locations

Locations (1)

Hospital Clínico Universitario; 🇪🇸 Valencia, Spain