Myocardial Infarction and Non-contraceptive Estrogen Use
Primary Purpose
Cardiovascular Diseases, Heart Diseases, Myocardial Infarction
Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Cardiovascular Diseases
Eligibility Criteria
No eligibility criteria
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00005185
First Posted
May 25, 2000
Last Updated
May 12, 2016
Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT00005185
Brief Title
Myocardial Infarction and Non-contraceptive Estrogen Use
Study Type
Observational
2. Study Status
Record Verification Date
May 2000
Overall Recruitment Status
Completed
Study Start Date
April 1986 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 1990 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
5. Study Description
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.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Heart Diseases, Myocardial Infarction, Menopause, Postmenopause
7. Study Design
10. Eligibility
Sex
Male
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
No eligibility criteria
12. IPD Sharing Statement
Citations:
PubMed Identifier
2725598
Citation
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.
Results Reference
background
PubMed Identifier
2294448
Citation
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.
Results Reference
background
PubMed Identifier
2343853
Citation
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.
Results Reference
background
PubMed Identifier
2356811
Citation
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.
Results Reference
background
PubMed Identifier
1415160
Citation
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.
Results Reference
background
PubMed Identifier
7709915
Citation
Palmer JR, Rosenberg L, Rao RS, Shapiro S. Coffee consumption and myocardial infarction in women. Am J Epidemiol. 1995 Apr 15;141(8):724-31. doi: 10.1093/oxfordjournals.aje.a117494.
Results Reference
background
PubMed Identifier
8434573
Citation
Rosenberg L, Palmer JR, Shapiro S. A case-control study of myocardial infarction in relation to use of estrogen supplements. Am J Epidemiol. 1993 Jan 1;137(1):54-63. doi: 10.1093/oxfordjournals.aje.a116602.
Results Reference
background
Learn more about this trial
Myocardial Infarction and Non-contraceptive Estrogen Use
We'll reach out to this number within 24 hrs