AzTrials
AzTrials

Cardiovascular DiseasesNCT00058669

CVD Risk Factors and Sexual Identity in Women

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 examine potential differences in the prevalence and pattern of risk factors for coronary heart disease in a sample of 500 self-identified lesbians and 500 heterosexual women, matched for age, socioeconomic status, and ethnicity. Read more about this study

Who is it for?
Ages 35 years and older, women onlyHealthy volunteers can take part
How many people
1,174 participants
Where
No sites listed yet
Study dates
Mar 2003to Feb 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 35 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Women over 35 Years age without cvd

Over 35 Years old no cvd

About this study

To examine potential differences in the prevalence and pattern of risk factors for coronary heart disease in a sample of 500 self-identified lesbians and 500 heterosexual women, matched for age, socioeconomic status, and ethnicity.

Read the detailed description

BACKGROUND:

Coronary heart disease (CHD) is the leading cause of mortality among women living in the United States, regardless of race and ethnicity and is likely the leading cause of mortality among lesbians. However, in various reports since 1994, the National Institute of Mental Health, the Centers for Disease Control and Prevention, the American Medical Association, the American Public Health Association, and the Institute of Medicine (IOM) have pointed out that health care and health research affecting lesbian women are inadequate. As women, lesbians share many of the same health concerns of all women. However, as emphasized in the IOM Report on Lesbian Health "factors assumed to place women at risk for or to protect them against health disorders may not be present at the same levels or operate in the same way for lesbians". The IOM report also recognizes that "women who self-identify as lesbian may also experience stressors not commonly faced by heterosexual women" and that "it is important to understand the factors that are unique to lesbians and their impact on lesbians' health". Data which do exist from household surveys and studies utilizing convenience samples indicate that women who identify as lesbian may differ from heterosexual women in several important factors which contribute to the development of CHD. However, to date there has not been a comprehensive examination of CHD risk in a large sample of women who identify as lesbian or an examination of how their pattern of risk factors or overall risk for CHD may differ from a sample of demographically similar heterosexual women.

DESIGN NARRATIVE:

The study is a case-control, cross-sectional survey that includes both behavior (alcohol, smoking, substance use, physical activity) and physiological (lipids, blood pressure, adiposity) measures. Self-identified lesbian women will be age, education, and racially matched to heterosexual women. The study will test the hypotheses that the prevalence and pattern of coronary heart disease (CHD) risk factors are different between lesbians and heterosexual women. The study will also determine the absolute and relative risk estimates for CHD based on the Framingham multiple-risk-factor assessment equations, and test the hypothesis that lesbians are at increased risk of CHD compared to heterosexual women.

Medical subject headings
Cardiovascular Diseases, Heart Diseases, Coronary Disease

What is being measured

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

  1. risk of cardiovascular disease

    Framingham risk profile

    Measured: single visit

Timeline

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

  1. First posted11 Apr 2003 (estimated)
  2. Study startMar 2003
  3. Primary completionFeb 2008
  4. Study completionFeb 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
Cross-sectional
Enrolment
1,174 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00058669
Sponsor's protocol ID
1210
Other IDs
R01HL067052
Status last verified
Jan 2016
First submitted
10 Apr 2003
Last updated
5 Jan 2016
Results posted
No
Data monitoring committee
No

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 5 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?

risk of cardiovascular disease (time frame: single visit). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 5 Jan 2016.

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