Estrogen Exposure and Atherosclerosis in Postmenopausal Women

Atherosclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02951949
• Other study ID #: Ayudas Fundación Eresa 2008
• Status: Completed
• Start date: November 2014
• Est. completion date: December 2015

Study information

• Verified date: April 2020
• Source: University of Valencia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: December 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 85 Years

Eligibility

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..

Related Conditions & MeSH terms

• Atherosclerosis
• Carotid Intima-media Thickness
• Coronary Stenoses
• Coronary Stenosis
• Estrogens
• Menopause
• Women

Locations

Country	Name	City	State
Spain	Hospital Clínico Universitario	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
University of Valencia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Carotid intima-media thickness.	Postmenopausal women attending clinical service for health control were measured carotid intima-media thickness by ultrasound.	12 weeks
Secondary	Changes in coronary calcium score.	Postmenopausal women attending clinical service for health control were measured the coronary calcium score with computed tomography.	12 weeks
Secondary	Changes in coronary lumen stenosis.	Postmenopausal women attending clinical service for health control were measured the coronary lumen stenosis with computed tomography.	12 weeks