Cardiovascular Diseases Clinical Trial
To investigate the relation between endogenous levels of estrogen in postmenopausal women and the subsequent development of coronary heart disease.
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 7,058
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.
;
Observational Model: Case Control, Time Perspective: Retrospective
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