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OpenTrials
Completed

NCT Number: NCT02951949

Estrogen Exposure and Atherosclerosis in Postmenopausal Women

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.

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Key information

Conditions

Atherosclerosis Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Carotid Intima-Media Thickness Coronary Disease Coronary Stenoses Coronary Stenosis Estrogens Heart Diseases Menopause Myocardial Ischemia Vascular Diseases Women

Age range

45 year–85 year

Sex eligibility

Female

Study type

Observational

Primary location

Hospital Clínico Universitario

Valencia, 46010, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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..

Treatment and study plan

Primary outcomes

  1. Carotid intima-media thickness.

    Time frame: 12 weeks

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

Secondary outcomes

  1. Changes in coronary calcium score.

    Time frame: 12 weeks

    Postmenopausal women attending clinical service for health control were measured the coronary calcium score with computed tomography.

  2. Changes in coronary lumen stenosis.

    Time frame: 12 weeks

    Postmenopausal women attending clinical service for health control were measured the coronary lumen stenosis with computed tomography.

Sponsors and collaborators

Lead sponsor

University of Valencia

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Nov 1, 2016
Registry last updated
Apr 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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