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Postmenopausal Progestins, MI and Stroke
This study has been completed.
First Received: May 25, 2000   Last Updated: June 23, 2005   History of Changes
Sponsored by: National Heart, Lung, and Blood Institute (NHLBI)
Information provided by: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT00005220
  Purpose

To evaluate the cardiovascular effects of postmenopausal hormone replacement therapy and the suspected beneficial effects on myocardial infarction and stroke.


Condition
Cardiovascular Diseases
Heart Diseases
Coronary Disease
Cerebrovascular Accident
Myocardial Infarction
Postmenopause

MedlinePlus related topics: Coronary Artery Disease Heart Attack Heart Diseases
U.S. FDA Resources
Study Type: Observational
Study Design: Natural History

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: April 1988
Estimated Study Completion Date: January 1999
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.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

No eligibility criteria

  Contacts and Locations
No Contacts or Locations Provided
  More Information

Publications:
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.
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.
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.
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.
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.
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.
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. Review.
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.
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.

Study ID Numbers: 1099
Study First Received: May 25, 2000
Last Updated: June 23, 2005
ClinicalTrials.gov Identifier: NCT00005220     History of Changes
Health Authority: United States: Federal Government

Study placed in the following topic categories:
Arterial Occlusive Diseases
Heart Diseases
Cerebral Infarction
Myocardial Ischemia
Stroke
Vascular Diseases
Central Nervous System Diseases
Ischemia
Arteriosclerosis
Brain Diseases
Cerebrovascular Disorders
Coronary Disease
Necrosis
Progestins
Brain Ischemia
Brain Infarction
Infarction
Myocardial Infarction
Coronary Artery Disease

Additional relevant MeSH terms:
Arterial Occlusive Diseases
Heart Diseases
Cerebral Infarction
Myocardial Ischemia
Nervous System Diseases
Stroke
Vascular Diseases
Central Nervous System Diseases
Arteriosclerosis
Ischemia
Brain Diseases
Cerebrovascular Disorders
Coronary Disease
Necrosis
Pathologic Processes
Brain Ischemia
Cardiovascular Diseases
Brain Infarction
Infarction
Myocardial Infarction
Coronary Artery Disease

ClinicalTrials.gov processed this record on May 07, 2009