Cardiovascular Diseases Clinical Trial
To evaluate whether the use of noncontraceptive estrogen influenced the incidence of first myocardial infarction in women.
BACKGROUND:
The use of noncontraceptive estrogens declined after evidence was published that they
increase the risk of endometrial cancer. Nonetheless, they are still used commonly and for
long periods, especially by hysterectomized women. Use of the drugs has increased recently,
perhaps because the drugs have been recommended as prophylaxis against osteoporosis. The
drugs are also being promoted for use in conjunction with a progestin, because it is thought
that the combination may protect against endometrial cancer. Little is known about the
effects of these drug regimens on myocardial infarction risk, and some progestins (in
particular the 19-norprogestins) are thought to influence lipid profiles unfavorably.
Insofar as myocardial infarction is a major cause of morbidity and mortality in women beyond
age 49, an effect of these drugs, either beneficial or adverse, on myocardial infarction
risk is of considerable public health importance.
DESIGN NARRATIVE:
The design was that of a case-control study. Cases were selected from women admitted for the
first episode of myocardial infarction to any of the participating hospitals in the Boston
area. For each case, a control was selected from town lists of women living in the same
neighborhood as the case and in the same five year age group. Cases were interviewed by
telephone after discharge from the hospital, and the corresponding control was interviewed
within a week or two of the case interview.
Information was obtained on: the timing and duration of non-contraceptive estrogen use, the
names of the preparations and reasons for starting and stopping each episode of use; other
drug use particularly oral contraceptives, aspirin, phenylpropanolamine; age at menopause;
cigarette smoking; height and weight; histories of previous myocardial infarction,
hypertension, pre-eclamptic toxemia, diabetes mellitus, angina pectoris and abnormal serum
lipids; reproductive history; alcohol and coffee consumption; personality type based on the
Framingham Type A Scale; family history of myocardial infarction; exercise; socioeconomic
and life style factors; number of physician visits in last two years and total number of
hospital admissions.
The study completion date listed in this record was obtained from the "End Date" entered in
the Protocol Registration and Results System (PRS) record.
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