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

Completed

• Conditions: Cardiovascular Diseases; Carotid Artery Diseases; Menopausal Syndrome; Heart Diseases; Depression

• Registration Number: NCT00005160
• Lead Sponsor: University of Pittsburgh

Brief Summary

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

Detailed Description

BACKGROUND:

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.

DESIGN NARRATIVE:

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 Timeline

• Study Start: 1983-04
• Study First Submitted: 2000-05-25
• Study First Submitted QC: 2000-05-25
• Study First Posted: 2000-05-26
• Primary Completion: 2008-11
• Study Completion: 2008-11
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-12
• Last Update Posted: 2016-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 532

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Predictors of coronary and aortic calcium and carotid intima media thickness and plaque in postmenopausal women at the fourth follow-up of the study	yearly