Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00081705
Status:
COMPLETED
Last Update Posted:
2016-07-29
First Post:
2004-04-19
Brief Title:
Estrogen Receptor Variants HDL and Atherosclerosis
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2008-01
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 measure the association between estrogen receptor variants and the extent of atherosclerosis in the thoracic and abdominal aorta and the right coronary artery in subjects in the PDAY study
Detailed Description:
BACKGROUND
Increased levels of HDL cholesterol are associated with lower rates of clinical and anatomic atherosclerosis even in adolescents and young adults In premenopausal women estrogen-associated increases in HDL may account for their low rates of coronary heart disease CHD events Recently a sequence variant in the estrogen receptor-alpha ER-alpha gene ER-alpha IVS1-397 TC has been linked to twofold greater increases in HDL cholesterol in response to hormone replacement therapy HRT However it remains unclear whether this sequence variant also augments HDL levels in the setting of premenopausal estrogen exposure and whether such differences translate into greater reductions in atherosclerosis risk The study uses the cohort of the Pathobiology of Atherosclerosis in Youth PDAY study a large cross-sectional autopsy study of the extent of atherosclerosis in subjects aged 15 to 34 years The detailed descriptions of atherosclerotic lesions combined with data on cardiovascular risk factors and access to tissue for DNA extraction makes this an ideal cohort in which to examine the association between ER-alpha IVS1-397 genotypes HDL levels and development of early atherosclerosis
DESIGN NARRATIVE
The overall goal for this study is to measure the association between the estrogen receptor ER- IVS1-401 TC polymorphism and extent of abdominal aorta thoracic artery and right coronary artery atherosclerosis in Pathobiological Determinants of Atherosclerosis in Youth PDAY subjects The investigators will use DNA extracted from liver specimens in order to measure the ER polymorphisms The extent of atherosclerosis will be defined as the percent of intimal area involved with fatty streaks or raised lesions using previously established PDAY definitions However percent involvement of fatty streaks alone and the percent involvement of the individual components of raised lesions fibrous plaques complicated lesions and calcified lesions will be analyzed separately Available data on risk factors smoking diabetes hyperlipidemia hypertension will permit reducing confounding of the results by allowing adjustments for effects of the major risk factors for coronary heart disease The Department of Pathology at Louisiana State University Health Sciences Center LSUHSC has been designated by the National Heart Lung and Blood Institute to centralize maintain and distribute the valuable material collected through the combined efforts of the cooperating institutions for further studies in atherosclerosis LSUHSC will provide DNA for polymorphism analysis and assist in data analysis Polymorphism determination will occur at Wake Forest
Increased levels of HDL cholesterol are associated with lower rates of clinical and anatomic atherosclerosis even in adolescents and young adults In premenopausal women estrogen-associated increases in HDL may account for their low rates of coronary heart disease CHD events Recently a sequence variant in the estrogen receptor-alpha ER-alpha gene ER-alpha IVS1-397 TC has been linked to twofold greater increases in HDL cholesterol in response to hormone replacement therapy HRT However it remains unclear whether this sequence variant also augments HDL levels in the setting of premenopausal estrogen exposure and whether such differences translate into greater reductions in atherosclerosis risk The study uses the cohort of the Pathobiology of Atherosclerosis in Youth PDAY study a large cross-sectional autopsy study of the extent of atherosclerosis in subjects aged 15 to 34 years The detailed descriptions of atherosclerotic lesions combined with data on cardiovascular risk factors and access to tissue for DNA extraction makes this an ideal cohort in which to examine the association between ER-alpha IVS1-397 genotypes HDL levels and development of early atherosclerosis
DESIGN NARRATIVE
The overall goal for this study is to measure the association between the estrogen receptor ER- IVS1-401 TC polymorphism and extent of abdominal aorta thoracic artery and right coronary artery atherosclerosis in Pathobiological Determinants of Atherosclerosis in Youth PDAY subjects The investigators will use DNA extracted from liver specimens in order to measure the ER polymorphisms The extent of atherosclerosis will be defined as the percent of intimal area involved with fatty streaks or raised lesions using previously established PDAY definitions However percent involvement of fatty streaks alone and the percent involvement of the individual components of raised lesions fibrous plaques complicated lesions and calcified lesions will be analyzed separately Available data on risk factors smoking diabetes hyperlipidemia hypertension will permit reducing confounding of the results by allowing adjustments for effects of the major risk factors for coronary heart disease The Department of Pathology at Louisiana State University Health Sciences Center LSUHSC has been designated by the National Heart Lung and Blood Institute to centralize maintain and distribute the valuable material collected through the combined efforts of the cooperating institutions for further studies in atherosclerosis LSUHSC will provide DNA for polymorphism analysis and assist in data analysis Polymorphism determination will occur at Wake Forest
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL072941 | NIH | None | httpsreporternihgovquickSearchR01HL072941 |