Cardiovascular DiseasesNCT00064532
Serum Sex Hormone Levels and Subclinical Atherosclerosis - Ancillary to MESA
An observational study of Cardiovascular Diseases and Atherosclerosis, run by Northwestern University.
Trial summary
To assess the associations of serum sex hormones with the presence and progression of subclinical atherosclerosis. Read more about this study
- Who is it for?
- Ages 45 to 84 years
- Conditions the study is for
- Cardiovascular Diseases, Atherosclerosis, Coronary Arteriosclerosis
- How many people
- 6,173 participants
- Where
- No sites listed yet
- Study dates
- Jul 2003to Jun 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 45 to 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Community sample of African-American, Chinese-American, Caucasian, and Hispanic residents drawn from six regions in the United States: Baltimore City and Baltimore County, Maryland; Chicago, Illinois; Forsyth County, North Carolina; Los Angeles County, California; New York, New York; and St. Paul, Minnesota.
Who may be able to join
None listed.
Who cannot join
- Age younger than 45 or older than 84 years
- Physician-diagnosed heart attack
- Physician-diagnosed angina or taking nitroglycerin
- Physician-diagnosed stroke or TIA
- Physician-diagnosed heart failure
- Current atrial fibrillation
Show all 16Show fewer
- Having undergone procedures related to cardiovascular disease (CABG, angioplasty, valve replacement, pacemaker or defibrillator implantation, any surgery on the heart or arteries)
- Active treatment for cancer
- Pregnancy
- Any serious medical condition which would prevent long-term participation
- Weight >300 pounds
- Cognitive inability as judged by the interviewer
- Living in a nursing home or on the waiting list for a nursing home
- Plans to leave the community within five years
- Language barrier (speaks other than English, Spanish, Cantonese or Mandarin)
- Chest CT scan in the past year
About this study
To assess the associations of serum sex hormones with the presence and progression of subclinical atherosclerosis.
Read the detailed description
BACKGROUND:
Throughout their lifetime, men are at higher risk of coronary heart disease (CHD) than women, however, after menopause this difference is attenuated. This observation suggests that endogenous sex hormones could be associated with CHD risk. There is some evidence indicating that the effect of sex hormones on CHD risk could be mediated, in part, by alterations in lipid levels or other CHD risk factors. However, other evidence supports an independent relationship of circulating hormone levels with CHD risk.
DESIGN NARRATIVE:
The study, which is ancillary to MESA, will examine the associations of serum sex hormone concentrations with the presence and progression of subclinical atherosclerosis in 3,259 male and 2,802 postmenopausal female participants of the Multi-Ethnic Study of Atherosclerosis (MESA). Subclinical atherosclerosis will be identified using both coronary artery calcium (CAC) and carotid intimal-medial wall thickness (IMT). Progression will be identified by the change in CAC over 3.5 years. Circulating concentrations of total (and free) testosterone (T), dehydroepiandrosterone (DHEA), 17 beta-estradiol (E2), and sex hormone binding globulin (SHBG) in stored serum samples collected at the MESA baseline exam will be assessed. Laboratory results will be merged with existing demographic, anthropometric, lifestyle, CHD risk factor, and subclinical disease data collected in MESA. Cross-sectional and prospective methods of statistical analysis will be used to assess the proposed associations. MESA is particularly well suited for disentangling the effects of hormonal factors and CHD risk factors on subclinical atherosclerosis because of the availability of high-quality data, serum samples, and CAC and IMT measurements in a large multi-ethnic population of men and women.
- Conditions
- Cardiovascular Diseases, Atherosclerosis, Coronary Arteriosclerosis, Coronary Disease, Heart Diseases
- Medical subject headings
- Cardiovascular Diseases, Atherosclerosis, Coronary Artery Disease, Coronary Disease, Heart Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Coronary artery calcium
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2003 (estimated)
- Study startJul 2003
- Primary completionJun 2008
- Study completionJun 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 Northwestern UniversityThe 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
- 6,173 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Kiang Liu, Northwestern University
- Investigators
- Susan Gapstur, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00064532
- Sponsor's protocol ID
- 1226
- Other IDs
- R01HL074338
- Status last verified
- Nov 2013
- First submitted
- 8 Jul 2003
- Last updated
- 3 Dec 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Sex Hormone Levels and Subclinical Atherosclerosis - Ancillary to MESA
- ClinicalTrials.gov ID
- NCT00064532
- Acronym / sponsor ID
- 1226
- Conditions
- Cardiovascular Diseases, Atherosclerosis, Coronary Arteriosclerosis, Coronary Disease, Heart Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,173 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jul 2003
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 10 Jul 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 assess the associations of serum sex hormones with the presence and progression of subclinical atherosclerosis.
Detailed description
BACKGROUND:
Throughout their lifetime, men are at higher risk of coronary heart disease (CHD) than women, however, after menopause this difference is attenuated. This observation suggests that endogenous sex hormones could be associated with CHD risk. There is some evidence indicating that the effect of sex hormones on CHD risk could be mediated, in part, by alterations in lipid levels or other CHD risk factors. However, other evidence supports an independent relationship of circulating hormone levels with CHD risk.
DESIGN NARRATIVE:
The study, which is ancillary to MESA, will examine the associations of serum sex hormone concentrations with the presence and progression of subclinical atherosclerosis in 3,259 male and 2,802 postmenopausal female participants of the Multi-Ethnic Study of Atherosclerosis (MESA). Subclinical atherosclerosis will be identified using both coronary artery calcium (CAC) and carotid intimal-medial wall thickness (IMT). Progression will be identified by the change in CAC over 3.5 years. Circulating concentrations of total (and free) testosterone (T), dehydroepiandrosterone (DHEA), 17 beta-estradiol (E2), and sex hormone binding globulin (SHBG) in stored serum samples collected at the MESA baseline exam will be assessed. Laboratory results will be merged with existing demographic, anthropometric, lifestyle, CHD risk factor, and subclinical disease data collected in MESA. Cross-sectional and prospective methods of statistical analysis will be used to assess the proposed associations. MESA is particularly well suited for disentangling the effects of hormonal factors and CHD risk factors on subclinical atherosclerosis because of the availability of high-quality data, serum samples, and CAC and IMT measurements in a large multi-ethnic population of men and women.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 45 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Community sample of African-American, Chinese-American, Caucasian, and Hispanic residents drawn from six regions in the United States: Baltimore City and Baltimore County, Maryland; Chicago, Illinois; Forsyth County, North Carolina; Los Angeles County, California; New York, New York; and St. Paul, Minnesota.
Key inclusion criteria (0 listed)
Key exclusion criteria (16 listed)
- Age younger than 45 or older than 84 years
- Physician-diagnosed heart attack
- Physician-diagnosed angina or taking nitroglycerin
- Physician-diagnosed stroke or TIA
- Physician-diagnosed heart failure
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
Coronary artery calcium
Time frame: Baseline
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 3 Dec 2014.
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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.
Susan Gapstur principal investigator
Northwestern University
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Atherosclerosis, run by Northwestern University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 16 exclusion criteria. 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 3 Dec 2014. 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?
Coronary artery calcium (time frame: Baseline). 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 3 Dec 2014.