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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00005160
First received: May 25, 2000
Last updated: June 18, 2013
Last verified: June 2013
  Purpose

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


Condition
Cardiovascular Diseases
Heart Diseases
Depression
Carotid Artery Diseases
Menopausal Complaints
Menopause

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Epidemiology of Cardiovascular Risk Factors in Women (Healthy Women Study)

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 532
Study Start Date: April 1983
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
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.

  Eligibility

Genders 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.

Criteria

Women had to be premenopausal, have an intact uterus and ovaries and have no hypertension, diabetes, heart disease, major cancer or stroke to be eligible for the study originally.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005160

Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Lewis Kuller University of Pittsburgh
  More Information

Publications:

Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00005160     History of Changes
Other Study ID Numbers: 1032, R01HL028266-26
Study First Received: May 25, 2000
Last Updated: June 18, 2013
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on November 20, 2014