Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00064532
Status:
COMPLETED
Last Update Posted:
2014-12-03
First Post:
2003-07-08
Brief Title:
Serum Sex Hormone Levels and Subclinical Atherosclerosis - Ancillary to MESA
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2013-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To assess the associations of serum sex hormones with the presence and progression of subclinical atherosclerosis
Detailed Description:
BACKGROUND
Throughout their lifetime men are at higher risk of coronary heart disease CHD than women however after menopause this difference is attenuated This observation suggests that endogenous sex hormones could be associated with CHD risk There is some evidence indicating that the effect of sex hormones on CHD risk could be mediated in part by alterations in lipid levels or other CHD risk factors However other evidence supports an independent relationship of circulating hormone levels with CHD risk
DESIGN NARRATIVE
The study which is ancillary to MESA will examine the associations of serum sex hormone concentrations with the presence and progression of subclinical atherosclerosis in 3259 male and 2802 postmenopausal female participants of the Multi-Ethnic Study of Atherosclerosis MESA Subclinical atherosclerosis will be identified using both coronary artery calcium CAC and carotid intimal-medial wall thickness IMT Progression will be identified by the change in CAC over 35 years Circulating concentrations of total and free testosterone T dehydroepiandrosterone DHEA 17 beta-estradiol E2 and sex hormone binding globulin SHBG in stored serum samples collected at the MESA baseline exam will be assessed Laboratory results will be merged with existing demographic anthropometric lifestyle CHD risk factor and subclinical disease data collected in MESA Cross-sectional and prospective methods of statistical analysis will be used to assess the proposed associations MESA is particularly well suited for disentangling the effects of hormonal factors and CHD risk factors on subclinical atherosclerosis because of the availability of high-quality data serum samples and CAC and IMT measurements in a large multi-ethnic population of men and women
Throughout their lifetime men are at higher risk of coronary heart disease CHD than women however after menopause this difference is attenuated This observation suggests that endogenous sex hormones could be associated with CHD risk There is some evidence indicating that the effect of sex hormones on CHD risk could be mediated in part by alterations in lipid levels or other CHD risk factors However other evidence supports an independent relationship of circulating hormone levels with CHD risk
DESIGN NARRATIVE
The study which is ancillary to MESA will examine the associations of serum sex hormone concentrations with the presence and progression of subclinical atherosclerosis in 3259 male and 2802 postmenopausal female participants of the Multi-Ethnic Study of Atherosclerosis MESA Subclinical atherosclerosis will be identified using both coronary artery calcium CAC and carotid intimal-medial wall thickness IMT Progression will be identified by the change in CAC over 35 years Circulating concentrations of total and free testosterone T dehydroepiandrosterone DHEA 17 beta-estradiol E2 and sex hormone binding globulin SHBG in stored serum samples collected at the MESA baseline exam will be assessed Laboratory results will be merged with existing demographic anthropometric lifestyle CHD risk factor and subclinical disease data collected in MESA Cross-sectional and prospective methods of statistical analysis will be used to assess the proposed associations MESA is particularly well suited for disentangling the effects of hormonal factors and CHD risk factors on subclinical atherosclerosis because of the availability of high-quality data serum samples and CAC and IMT measurements in a large multi-ethnic population of men and women
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL074338 | NIH | None | httpsreporternihgovquickSearchR01HL074338 |