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Postmenopausal Progestins, MI and Stroke

Primary Purpose

Cardiovascular Diseases, Heart Diseases, Coronary Disease

Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
University of Washington
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Cardiovascular Diseases

Eligibility Criteria

undefined - 100 Years (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

No eligibility criteria

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    May 25, 2000
    Last Updated
    February 8, 2016
    Sponsor
    University of Washington
    Collaborators
    National Heart, Lung, and Blood Institute (NHLBI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00005220
    Brief Title
    Postmenopausal Progestins, MI and Stroke
    Study Type
    Observational

    2. Study Status

    Record Verification Date
    June 2000
    Overall Recruitment Status
    Completed
    Study Start Date
    April 1988 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    January 1999 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    University of Washington
    Collaborators
    National Heart, Lung, and Blood Institute (NHLBI)

    4. Oversight

    5. Study Description

    Brief Summary
    To evaluate the cardiovascular effects of postmenopausal hormone replacement therapy and the suspected beneficial effects on myocardial infarction and stroke.
    Detailed Description
    BACKGROUND: Post-menopausal women who use estrogens generally experience at once a reduced risk of coronary heart disease and, at the same time, an increased risk of endometrial cancer. In order to protect the endometrium from unopposed estrogens, many physicians now recommend the addition of a progestin during 10-13 days of the cycle. Progestins may be implicated in the increased risk of myocardial infarction in women on oral contraceptives. DESIGN NARRATIVE: This was a case-control study. The computerized files of the Group Health Cooperative (GHC) in Seattle were used to identify cases. All postmenopausal women, aged 40 to 79, were eligible as cases if, according to World Health Organization criteria, they presented with a fatal or non-fatal myocardial infarction. A random sample of women listed in the enrollment files at GHC served as a source of potential controls. Review of the out-patient medical records, performed by an assistant blind to case-control status ensured that all study subjects met the same criteria. Telephone interviews were used to obtain information about exposure to postmenopausal hormones as well as known risk factors. The computerized pharmacy records at GHC provided additional information about exposure. Frequency matching controlled for the potential confounding effects of age and year of presentation. Stratification and logistic regression were used in data analysis. The study was renewed in 1995 to make more precise some of the indeterminate findings related to current use, cumulative dose and duration of use but also to extend the assessment of the risk or benefit to incident strokes. The study ended in January, 1999.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cardiovascular Diseases, Heart Diseases, Coronary Disease, Cerebrovascular Accident, Myocardial Infarction, 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
    8872841
    Citation
    Lahad A, Heckbert SR, Patrick DL, Psaty BM. Hostility, aggression and the association with hypertension in post-menopausal women. J Hum Hypertens. 1996 Sep;10 Suppl 3:S115-21.
    Results Reference
    background
    PubMed Identifier
    1853865
    Citation
    Psaty BM, Cheadle A, Curry S, McKenna T, Koepsell TD, Wickizer T, VonKorff M, Diehr P, Perrin EB, Wagner EH. Sampling elderly in the community: a comparison of commercial telemarketing lists and random digit dialing techniques for assessing health behaviors and health status. Am J Epidemiol. 1991 Jul 1;134(1):96-106. doi: 10.1093/oxfordjournals.aje.a115997.
    Results Reference
    background
    PubMed Identifier
    2066748
    Citation
    Koepsell TD, Martin DC, Diehr PH, Psaty BM, Wagner EH, Perrin EB, Cheadle A. Data analysis and sample size issues in evaluations of community-based health promotion and disease prevention programs: a mixed-model analysis of variance approach. J Clin Epidemiol. 1991;44(7):701-13. doi: 10.1016/0895-4356(91)90030-d.
    Results Reference
    background
    PubMed Identifier
    7487254
    Citation
    Lemaitre RN, Heckbert SR, Psaty BM, Siscovick DS. Leisure-time physical activity and the risk of nonfatal myocardial infarction in postmenopausal women. Arch Intern Med. 1995 Nov 27;155(21):2302-8.
    Results Reference
    background
    PubMed Identifier
    7637142
    Citation
    Psaty BM, Heckbert SR, Koepsell TD, Siscovick DS, Raghunathan TE, Weiss NS, Rosendaal FR, Lemaitre RN, Smith NL, Wahl PW, et al. The risk of myocardial infarction associated with antihypertensive drug therapies. JAMA. 1995 Aug 23-30;274(8):620-5.
    Results Reference
    background
    PubMed Identifier
    8002685
    Citation
    Psaty BM, Heckbert SR, Atkins D, Lemaitre R, Koepsell TD, Wahl PW, Siscovick DS, Wagner EH. The risk of myocardial infarction associated with the combined use of estrogens and progestins in postmenopausal women. Arch Intern Med. 1994 Jun 27;154(12):1333-9.
    Results Reference
    background
    PubMed Identifier
    8512434
    Citation
    Psaty BM, Heckbert SR, Atkins D, Siscovick DS, Koepsell TD, Wahl PW, Longstreth WT Jr, Weiss NS, Wagner EH, Prentice R, et al. A review of the association of estrogens and progestins with cardiovascular disease in postmenopausal women. Arch Intern Med. 1993 Jun 28;153(12):1421-7.
    Results Reference
    background
    PubMed Identifier
    9201007
    Citation
    Heckbert SR, Weiss NS, Koepsell TD, Lemaitre RN, Smith NL, Siscovick DS, Lin D, Psaty BM. Duration of estrogen replacement therapy in relation to the risk of incident myocardial infarction in postmenopausal women. Arch Intern Med. 1997 Jun 23;157(12):1330-6.
    Results Reference
    background
    PubMed Identifier
    9278907
    Citation
    Lahad A, Heckbert SR, Koepsell TD, Psaty BM, Patrick DL. Hostility, aggression and the risk of nonfatal myocardial infarction in postmenopausal women. J Psychosom Res. 1997 Aug;43(2):183-95. doi: 10.1016/s0022-3999(96)00369-8.
    Results Reference
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    Postmenopausal Progestins, MI and Stroke

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