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Estrogen Exposure and Atherosclerosis in Postmenopausal Women

Exposure to Endogenous Estrogens and Imaging Parameters of Atherosclerosis Burden in Postmenopausal Women

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02951949
Enrollment
92
Registered
2016-11-01
Start date
2014-11-30
Completion date
2015-12-31
Last updated
2020-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

atherosclerosis, endogenous estrogens, age

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.

Interventions

None listed

Sponsors

University of Valencia
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
Age
45 Years to 85 Years
Healthy volunteers
Yes

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..

Design outcomes

Primary

MeasureTime frameDescription
Carotid intima-media thickness.12 weeksPostmenopausal women attending clinical service for health control were measured carotid intima-media thickness by ultrasound.

Secondary

MeasureTime frameDescription
Changes in coronary calcium score.12 weeksPostmenopausal women attending clinical service for health control were measured the coronary calcium score with computed tomography.
Changes in coronary lumen stenosis.12 weeksPostmenopausal women attending clinical service for health control were measured the coronary lumen stenosis with computed tomography.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026