Epidemiology of Cardiovascular Risk Factors in Women (Healthy Women Study)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00005160
Recruitment Status : Completed
First Posted : May 26, 2000
Last Update Posted : January 13, 2016
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
University of Pittsburgh

Brief Summary:
To determine cardiovascular risk factors and the change in risk factors during and following the menopause.

Condition or disease
Cardiovascular Diseases Heart Diseases Depression Carotid Artery Diseases Menopausal Syndrome

Detailed Description:


In 1983, when the Healthy Women Study began, there was a paucity of epidemiological studies of cardiovascular risk factor changes and risk of heart disease related to natural menopause. The Healthy Women Study was one of the few in which the status of premenopausal women was followed carefully through and subsequent to the menopause. The study also included detailed behavioral and biological measures, as well as important environmental factors related to the determinants of these risk factors.


A cross-sectional study was conducted to determine the relationship between risk factors, behavioral, psychosocial, and other environmental determinants. A five year longitudinal follow-up of the women evaluated changes over time in risk factors related to the perimenopausal and postmenopausal periods. Longitudinal follow-up after the menopause continues in order to determine the relationships among changes in behavior, hormones, habits, and risk factors.

The women had home interviews, baseline examinations, follow-up of menstrual cycles, and a six-month self-administered questionnaire. Risk factors studied included behavioral factors, glucose and insulin, obesity, exercise, cigarette smoking, nutrition, lipoproteins, blood pressure, and hormones. Surgical menopause and the use of exogenous hormones were also studied. Although not part of the original protocol, measurements of fat distribution, coagulation factors, apoproteins, sodium-lithium counter-transport, and sodium-hydrogen exchange in platelets were added.

The study was renewed in 1995 to continue follow-up to determine characteristics of changes in risk factors, behavioral/psychological attributes and to determine the relationship between risk factors, and their changes and atherosclerotic plaque and wall thickness. Studies are conducted on the interrelationship of lifestyle and behavioral attributed to sex-steroid hormones and insulin and the level of hormones to atherosclerosis. A determination is made of the association of lifestyle to amount and distribution of body fat measured by DEXA and CT of the abdomen.

The study has been renewed several times and ends in November of 2007.

Study Type : Observational
Actual Enrollment : 532 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Epidemiology of Cardiovascular Risk Factors in Women (Healthy Women Study)
Study Start Date : April 1983
Actual Primary Completion Date : November 2008
Actual Study Completion Date : November 2008

Primary Outcome Measures :
  1. Predictors of coronary and aortic calcium and carotid intima media thickness and plaque in postmenopausal women at the fourth follow-up of the study [ Time Frame: yearly ]

Biospecimen Retention:   Samples Without DNA
Plasma and serum samples from baseline and follow up exams stored at -80 degrees Celsius in the Department of Epidemiology, Graduate School of Public Health, University of Pittsburgh.

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Ages Eligible for Study:   20 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
The study began in 1983-84, baseline age was 48, median age was 47. The first EBT examination was added to the study at the approximate time of the 8th postmenopausal visit in 1992-93. 249 women in this grant period.

Inclusion criteria: Women had to be premenopausal and have an intact uterus and ovaries

Exclusion criteria: hypertension, diabetes, heart disease, major cancer or stroke

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00005160

Sponsors and Collaborators
University of Pittsburgh
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Lewis Kuller University of Pittsburgh


Responsible Party: University of Pittsburgh Identifier: NCT00005160     History of Changes
Other Study ID Numbers: 1032
R01HL028266-26 ( U.S. NIH Grant/Contract )
First Posted: May 26, 2000    Key Record Dates
Last Update Posted: January 13, 2016
Last Verified: January 2016

Additional relevant MeSH terms:
Cardiovascular Diseases
Heart Diseases
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases