Atherosclerosis Clinical Trial
Official title:
Exposure to Endogenous Estrogens and Imaging Parameters of Atherosclerosis Burden in Postmenopausal Women
Verified date | April 2020 |
Source | University of Valencia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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.. |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Clínico Universitario | Valencia |
Lead Sponsor | Collaborator |
---|---|
University of Valencia |
Spain,
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 |
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