Cardiovascular DiseasesNCT00058669
CVD Risk Factors and Sexual Identity in Women
An observational study of Cardiovascular Diseases and Heart Diseases, run by University of Pittsburgh.
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
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases, Coronary Disease
- 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.
- Conditions
- Cardiovascular Diseases, Heart Diseases, Coronary Disease
- 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.
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.
- First posted11 Apr 2003 (estimated)
- Study startMar 2003
- Primary completionFeb 2008
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Nina Markovic, University of Pittsburgh
- Investigators
- nina markovivc, phd, Principal investigator, University of Pittsburgh
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
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CVD Risk Factors and Sexual Identity in Women
- ClinicalTrials.gov ID
- NCT00058669
- Acronym / sponsor ID
- 1210
- Conditions
- Cardiovascular Diseases, Heart Diseases, Coronary Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,174 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Mar 2003
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 11 Apr 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 35 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women over 35 Years age without cvd
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
risk of cardiovascular disease
Time frame: single visit
Framingham risk profile
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
nina markovivc, phd principal investigator
University of Pittsburgh
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.