Myocardial Infarction and Past Oral Contraceptive Use
| Tracking Information | |
|---|---|
| First Received Date ICMJE | May 25, 2000 |
| Last Updated Date | June 23, 2005 |
| Start Date ICMJE | April 1985 |
| Primary Completion Date | Not Provided |
| Current Primary Outcome Measures ICMJE | Not Provided |
| Original Primary Outcome Measures ICMJE | Not Provided |
| Change History | Complete list of historical versions of study NCT00005173 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | Not Provided |
| Original Secondary Outcome Measures ICMJE | Not Provided |
| Current Other Outcome Measures ICMJE | Not Provided |
| Original Other Outcome Measures ICMJE | Not Provided |
| Descriptive Information | |
| Brief Title ICMJE | Myocardial Infarction and Past Oral Contraceptive Use |
| Official Title ICMJE | Not Provided |
| Brief Summary | To evaluate whether the long-term use of oral contraceptives, after discontinuation, was associated with an increased incidence of first nonfatal myocardial infarction among women above the age of 50. |
| 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. |
| Study Type ICMJE | Observational |
| Study Design ICMJE | Observational Model: Natural History |
| Target Follow-Up Duration | Not Provided |
| Biospecimen | Not Provided |
| Sampling Method | Not Provided |
| Study Population | Not Provided |
| Condition ICMJE |
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| Intervention ICMJE | Not Provided |
| Study Group/Cohort (s) | Not Provided |
| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | Not Provided |
| Completion Date | April 1989 |
| Primary Completion Date | Not Provided |
| Eligibility Criteria ICMJE | No eligibility criteria |
| Gender | Male |
| Ages | Not Provided |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | Not Provided |
| Administrative Information | |
| NCT Number ICMJE | NCT00005173 |
| Other Study ID Numbers ICMJE | 1048 |
| Has Data Monitoring Committee | Not Provided |
| Responsible Party | Not Provided |
| Study Sponsor ICMJE | National Heart, Lung, and Blood Institute (NHLBI) |
| Collaborators ICMJE | Not Provided |
| Investigators ICMJE | Not Provided |
| Information Provided By | National Heart, Lung, and Blood Institute (NHLBI) |
| Verification Date | July 2000 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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