Clinical trial NCT02951949: Estrogen Exposure and Atherosclerosis in Postmenopausal Women
Official title: Exposure to Endogenous Estrogens and Imaging Parameters of Atherosclerosis Burden in Postmenopausal Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atherosclerosis
Menopause
Estrogens
Carotid Intima-media Thickness
Coronary Stenoses
Women
Keywords: atherosclerosis, endogenous estrogens, age
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2016-11-01
Enrollment: 92
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Postmenopausal women attending a clinical outpatient service in a third-level hospital for health control.

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.

Eligibility criteria: 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..

Primary outcomes:
measure: Carotid intima-media thickness.
timeFrame: 12 weeks
Secondary outcomes:
measure: Changes in coronary calcium score.
timeFrame: 12 weeks
measure: Changes in coronary lumen stenosis.
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Hospital Clínico Universitario
Study officials:
affiliation: University of Valencia
name: Antonio Cano, MD
role: PRINCIPAL_INVESTIGATOR
References: