Myocardial Infarction and Non-Contraceptive Estrogen Use
| Tracking Information | |
|---|---|
| First Received Date ICMJE | May 25, 2000 |
| Last Updated Date | June 23, 2005 |
| Start Date ICMJE | April 1986 |
| 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 NCT00005185 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 Non-Contraceptive Estrogen Use |
| Official Title ICMJE | Not Provided |
| Brief Summary | To evaluate whether the use of noncontraceptive estrogen influenced the incidence of first myocardial infarction in women. |
| Detailed Description | 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. |
| 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 | March 1990 |
| 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 | NCT00005185 |
| Other Study ID Numbers ICMJE | 1063 |
| 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 | May 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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