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Cardiovascular DiseasesNCT00005160

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

An observational study of Cardiovascular Diseases and Heart Diseases, run by University of Pittsburgh.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To determine cardiovascular risk factors and the change in risk factors during and following the menopause. Read more about this study

Who is it for?
Ages 20 to 100 years, women onlyHealthy volunteers can take part
How many people
532 participants
Where
No sites listed yet
Study dates
Apr 1983to Nov 2008
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 100 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

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

About this study

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

Read the 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.

Medical subject headings
Cardiovascular Diseases, Heart Diseases, Depression, Carotid Artery Diseases

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: yearly

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 May 2000 (estimated)
  2. Study startApr 1983
  3. Primary completionNov 2008
  4. Study completionNov 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
532 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00005160
Sponsor's protocol ID
1032
Other IDs
R01HL028266-26
Status last verified
Jan 2016
First submitted
25 May 2000
Last updated
13 Jan 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • Meilahn E, Ferrell R, Kiss J, Temple A, Green F, Humphries S, Kuller L. Genetic determination of coagulation factor VIIc levels among healthy middle-aged women. Thromb Haemost. 1995 Apr;73(4):623-5.

    PubMed 7495069

  • Matthews KA, Kuller LH, Wing RR, Meilahn EN, Plantinga P. Prior to use of estrogen replacement therapy, are users healthier than nonusers? Am J Epidemiol. 1996 May 15;143(10):971-8. doi: 10.1093/oxfordjournals.aje.a008678.

    PubMed 8629615

  • Walker VR, Dombi GW, Gutai JP, Wade DD, Swartz KH, Liu H, Schroeder RR. Semiautomated method for the quantitation of plasma or sera androstenedione, testosterone, and dihydrotestosterone in population studies. Anal Biochem. 1996 Feb 15;234(2):194-203. doi: 10.1006/abio.1996.0072.

    PubMed 8714598

  • Bromberger JT, Matthews KA. A longitudinal study of the effects of pessimism, trait anxiety, and life stress on depressive symptoms in middle-aged women. Psychol Aging. 1996 Jun;11(2):207-13. doi: 10.1037//0882-7974.11.2.207.

    PubMed 8795049

  • Bromberger JT, Matthews KA. A "feminine" model of vulnerability to depressive symptoms: a longitudinal investigation of middle-aged women. J Pers Soc Psychol. 1996 Mar;70(3):591-8. doi: 10.1037//0022-3514.70.3.591.

    PubMed 8851743

  • Bromberger JT, Matthews KA, Kuller LH, Wing RR, Meilahn EN, Plantinga P. Prospective study of the determinants of age at menopause. Am J Epidemiol. 1997 Jan 15;145(2):124-33. doi: 10.1093/oxfordjournals.aje.a009083.

    PubMed 9006309

  • Evans RW, Sankey SS, Hauth BA, Sutton-Tyrrell K, Kamboh MI, Kuller LH. Effect of sample storage on quantitation of lipoprotein(a) by an enzyme-linked immunosorbent assay. Lipids. 1996 Nov;31(11):1197-203. doi: 10.1007/BF02524295.

    PubMed 8934453

  • Lassila HC, Tyrrell KS, Matthews KA, Wolfson SK, Kuller LH. Prevalence and determinants of carotid atherosclerosis in healthy postmenopausal women. Stroke. 1997 Mar;28(3):513-7. doi: 10.1161/01.str.28.3.513.

    PubMed 9056604

  • D'Elio MA, Ness RB, Matthews KA, Kuller LH. Are life stress and social support related to parity in women? Behav Med. 1997 Summer;23(2):87-94. doi: 10.1080/08964289709596732.

    PubMed 9309348

  • Meilahn EN, Kuller LH, Stein EA, Caggiula AW, Matthews KA. Characteristics associated with apoprotein and lipoprotein lipid levels in middle-aged women. Arteriosclerosis. 1988 Sep-Oct;8(5):515-20. doi: 10.1161/01.atv.8.5.515.

    PubMed 3142451

  • Egeland GM, Matthews KA, Kuller LH, Kelsey SF. Characteristics of noncontraceptive hormone users. Prev Med. 1988 Jul;17(4):403-11. doi: 10.1016/0091-7435(88)90039-4.

    PubMed 3217373

  • Matthews KA, Kelsey SF, Meilahn EN, Kuller LH, Wing RR. Educational attainment and behavioral and biologic risk factors for coronary heart disease in middle-aged women. Am J Epidemiol. 1989 Jun;129(6):1132-44. doi: 10.1093/oxfordjournals.aje.a115235.

    PubMed 2729252

  • Wing RR, Bunker CH, Kuller LH, Matthews KA. Insulin, body mass index, and cardiovascular risk factors in premenopausal women. Arteriosclerosis. 1989 Jul-Aug;9(4):479-84. doi: 10.1161/01.atv.9.4.479.

    PubMed 2665702

  • Matthews KA, Meilahn E, Kuller LH, Kelsey SF, Caggiula AW, Wing RR. Menopause and risk factors for coronary heart disease. N Engl J Med. 1989 Sep 7;321(10):641-6. doi: 10.1056/NEJM198909073211004.

    PubMed 2488072

  • Wing RR, Kuller LH, Bunker C, Matthews K, Caggiula A, Meihlan E, Kelsey S. Obesity, obesity-related behaviors and coronary heart disease risk factors in black and white premenopausal women. Int J Obes. 1989;13(4):511-9.

    PubMed 2793303

Questions about this trial

What is this clinical trial studying?

An observational study of Cardiovascular Diseases and Heart Diseases, run by University of Pittsburgh.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00005160, which also lists 63 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2016.

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