Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005446
Status:
COMPLETED
Last Update Posted:
2015-12-31
First Post:
2000-05-25
Brief Title:
Endogenous Estrogen and Coronary Heart Disease in Women
Sponsor:
NYU Langone Health
Organization:
NYU Langone Health
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2015-12
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 investigate the relation between endogenous levels of estrogen in postmenopausal women and the subsequent development of coronary heart disease
Detailed Description:
BACKGROUND
Studies suggest that estrogen replacement therapy ERT lowers the risk of coronary heart disease in postmenopausal women However it is not known whether higher endogenous levels of estrogens in the postmenopausal period likewise have a protective effect
DESIGN NARRATIVE
The study used an existing resource of frozen blood samples from a cohort of 7058 postmenopausal women enrolled between 1985 and 1991 for a study of endogenous hormones and cancer The cohort was followed up to identify incident cases of coronary heart disease One hundred thirty cases of coronary heart disease defined as nonfatal myocardial infarction or death from coronary heart disease were expected to occur by the end of follow-up A nested case-control study was conducted in which each case was matched to two women from the cohort who were the same age as the case donated blood around the same time and were alive and free of heart disease as of the date of diagnosis of the case Frozen serum samples from cases and their matched controls were analyzed for total estradiol bioavailable estradiol the estradiol fraction not bound to sex hormone binding globulin estrone total cholesterol and high- and low-density lipoprotein cholesterol Conditional logistic regression for matched sets were employed to determine whether estrogen levels were lower in the cases than their matched controls The association between estrogen levels and cholesterol fractions was also investigated
Studies suggest that estrogen replacement therapy ERT lowers the risk of coronary heart disease in postmenopausal women However it is not known whether higher endogenous levels of estrogens in the postmenopausal period likewise have a protective effect
DESIGN NARRATIVE
The study used an existing resource of frozen blood samples from a cohort of 7058 postmenopausal women enrolled between 1985 and 1991 for a study of endogenous hormones and cancer The cohort was followed up to identify incident cases of coronary heart disease One hundred thirty cases of coronary heart disease defined as nonfatal myocardial infarction or death from coronary heart disease were expected to occur by the end of follow-up A nested case-control study was conducted in which each case was matched to two women from the cohort who were the same age as the case donated blood around the same time and were alive and free of heart disease as of the date of diagnosis of the case Frozen serum samples from cases and their matched controls were analyzed for total estradiol bioavailable estradiol the estradiol fraction not bound to sex hormone binding globulin estrone total cholesterol and high- and low-density lipoprotein cholesterol Conditional logistic regression for matched sets were employed to determine whether estrogen levels were lower in the cases than their matched controls The association between estrogen levels and cholesterol fractions was also investigated
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 |
|---|---|---|---|
| R29HL052123 | NIH | None | httpsreporternihgovquickSearchR29HL052123 |