- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00005173
Myocardial Infarction and Past Oral Contraceptive Use
Study Overview
Status
Detailed Description
BACKGROUND:
In the mid 1980s, it was known that current oral contraceptive use (in the preceding month) increased the risk of myocardial infarction three to four-fold. Evidence seemed to indicate that past use lasting a total of five or more years was associated with a residual two-fold increase in myocardial infarction risk among women 40 to 49 years old. Since the incidence of the disease started to become appreciable beyond age 49, it was of public health importance to reexamine the evidence in a data base which included women aged 50 or older to determine how long the increased risk persisted and whether it varied according to the formulation of the preparation used. An increase in risk that persisted after discontinuation of oral contraceptive use would have major public health implications since millions of women have used or will use oral contraceptives for long periods.
DESIGN NARRATIVE:
The design was that of a case-control study. Cases were identified by weekly telephone calls to the coronary care units of 78 hospitals in greater Boston, Southern Connecticut, and Westchester County. Nurse-interviewers administered standard interviews to cases convalescing on medical wards after discharge from coronary care units and to controls identified in the same hospitals. Histories of oral contraceptive use, including the timing and duration of use and the name of the preparations, were recorded along with information on other drug use and myocardial infarction risk factors such as cigarette smoking. Data were collected for three years.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
Study Type
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Study Plan
How is the study designed?
Collaborators and Investigators
Publications and helpful links
General Publications
- Palmer JR, Rosenberg L, Shapiro S. "Low yield" cigarettes and the risk of nonfatal myocardial infarction in women. N Engl J Med. 1989 Jun 15;320(24):1569-73. doi: 10.1056/NEJM198906153202401.
- Palmer JR, Rosenberg L, Shapiro S. Stature and the risk of myocardial infarction in women. Am J Epidemiol. 1990 Jul;132(1):27-32. doi: 10.1093/oxfordjournals.aje.a115639.
- Rosenberg L, Palmer JR, Lesko SM, Shapiro S. Oral contraceptive use and the risk of myocardial infarction. Am J Epidemiol. 1990 Jun;131(6):1009-16. doi: 10.1093/oxfordjournals.aje.a115592.
- Rosenberg L, Palmer JR, Shapiro S. Decline in the risk of myocardial infarction among women who stop smoking. N Engl J Med. 1990 Jan 25;322(4):213-7. doi: 10.1056/NEJM199001253220401.
- Palmer JR, Rosenberg L, Shapiro S. Reproductive factors and risk of myocardial infarction. Am J Epidemiol. 1992 Aug 15;136(4):408-16. doi: 10.1093/oxfordjournals.aje.a116513.
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1048
- R01HL030225 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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