AtherosclerosisNCT00091494
Socioeconomic Patterning of Inflammation and Hemostasis - Ancillary to MESA
An observational study of Atherosclerosis and Cardiovascular Diseases, run by University of Michigan.
Trial summary
To investigate how inflammation, hemostasis, and stress may contribute to neighborhood and individual-level socioeconomic differences in cardiovascular risk. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Atherosclerosis, Cardiovascular Diseases, Heart Diseases
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- Sep 2004to 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This is an ancillary study to MESA.
Participants at NY and LA MESA sites.
About this study
To investigate how inflammation, hemostasis, and stress may contribute to neighborhood and individual-level socioeconomic differences in cardiovascular risk.
Read the detailed description
BACKGROUND:
In epidemiologic studies, associations of cardiovascular risk with individual and neighborhood socioeconomic characteristics tend to persist after adjustment for established cardiovascular risk factors suggesting that other mediators may be involved. However, evidence regarding what these mediators may be is largely absent. Elucidating the reasons for these persistent socioeconomic differences may enhance our ability to reduce these differentials and will contribute to our understanding of the causes of cardiovascular disease generally. Two biological processes, inflammation and hemostasis, have recently emerged as potentially important in the development of atherosclerosis and the precipitation of clinical cardiovascular events. Both processes have also been recently linked to psychosocial factors and stress. However, studies investigating social gradients in inflammation and hemostasis remain rare. In addition, the relation of psychosocial factors and biological markers of the stress response to inflammation and hemostasis have not been examined in large population-based studies.
DESIGN NARRATIVE:
The study is ancillary to the ongoing epidemiologic study of atherosclerosis, the Multi-Ethnic Study of Atherosclerosis (MESA). The project will collect data on stress hormones and follow- up measures of inflammation and hemostasis which are not part of the existing MESA protocol on a subsample of the cohort. The study will also collect additional data on neighborhood sources of stress for the subsample. The new data will be linked to existing MESA data.
Using newly collected data linked to the MESA, the study will investigate (1) associations of neighborhood and individual-level socioeconomic indicators with markers of inflammation and hemostasis; (2) associations of individual-level psychosocial factors and sources of chronic stress (at the individual and neighborhood level) with inflammatory markers and hemostasis; and (3) the relationship between biological markers of the stress response (such as cortisol and adrenaline/noradrenaline) and inflammation and hemostasis). Project aims will be achieved by linking MESA data to newly-collected data on neighborhood characteristics and biomarkers of inflammation, hemostasis and the stress response in MESA participants. The project is innovative in that it will span and link three levels: the social/environmental level (neighborhood characteristics and social position), the behavioral/psychological level (behavioral and psychosocial factors), and the biological level (inflammation, hemostasis, and stress hormones). The study will provide a unique opportunity to elucidate the links between socioeconomic factors, stress, inflammation and hemostasis in a large and diverse population-based sample.
- Conditions
- Atherosclerosis, Cardiovascular Diseases, Heart Diseases, Inflammation, Blood Coagulation Disorders
- Medical subject headings
- Atherosclerosis, Cardiovascular Diseases, Heart Diseases, Inflammation, Blood Coagulation Disorders
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2004 (estimated)
- Study startSep 2004
- 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 AtherosclerosisStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Investigators
- Ana Diez Roux, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00091494
- Sponsor's protocol ID
- 1268
- Other IDs
- R01HL076831
- Status last verified
- Jul 2008
- First submitted
- 9 Sep 2004
- Last updated
- 11 Apr 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Socioeconomic Patterning of Inflammation and Hemostasis - Ancillary to MESA
- ClinicalTrials.gov ID
- NCT00091494
- Acronym / sponsor ID
- 1268
- Conditions
- Atherosclerosis, Cardiovascular Diseases, Heart Diseases, Inflammation, Blood Coagulation Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Sep 2004
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 13 Sep 2004 (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 investigate how inflammation, hemostasis, and stress may contribute to neighborhood and individual-level socioeconomic differences in cardiovascular risk.
Detailed description
BACKGROUND:
In epidemiologic studies, associations of cardiovascular risk with individual and neighborhood socioeconomic characteristics tend to persist after adjustment for established cardiovascular risk factors suggesting that other mediators may be involved. However, evidence regarding what these mediators may be is largely absent. Elucidating the reasons for these persistent socioeconomic differences may enhance our ability to reduce these differentials and will contribute to our understanding of the causes of cardiovascular disease generally. Two biological processes, inflammation and hemostasis, have recently emerged as potentially important in the development of atherosclerosis and the precipitation of clinical cardiovascular events. Both processes have also been recently linked to psychosocial factors and stress. However, studies investigating social gradients in inflammation and hemostasis remain rare. In addition, the relation of psychosocial factors and biological markers of the stress response to inflammation and hemostasis have not been examined in large population-based studies.
DESIGN NARRATIVE:
The study is ancillary to the ongoing epidemiologic study of atherosclerosis, the Multi-Ethnic Study of Atherosclerosis (MESA). The project will collect data on stress hormones and follow- up measures of inflammation and hemostasis which are not part of the existing MESA protocol on a subsample of the cohort. The study will also collect additional data on neighborhood sources of stress for the subsample. The new data will be linked to existing MESA data.
Using newly collected data linked to the MESA, the study will investigate (1) associations of neighborhood and individual-level socioeconomic indicators with markers of inflammation and hemostasis; (2) associations of individual-level psychosocial factors and sources of chronic stress (at the individual and neighborhood level) with inflammatory markers and hemostasis; and (3) the relationship between biological markers of the stress response (such as cortisol and adrenaline/noradrenaline) and inflammation and hemostasis). Project aims will be achieved by linking MESA data to newly-collected data on neighborhood characteristics and biomarkers of inflammation, hemostasis and the stress response in MESA participants. The project is innovative in that it will span and link three levels: the social/environmental level (neighborhood characteristics and social position), the behavioral/psychological level (behavioral and psychosocial factors), and the biological level (inflammation, hemostasis, and stress hormones). The study will provide a unique opportunity to elucidate the links between socioeconomic factors, stress, inflammation and hemostasis in a large and diverse population-based sample.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is an ancillary study to MESA.
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
Not reported in the source record.
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 11 Apr 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.
Ana Diez Roux principal investigator
University of Michigan
Questions about this trial
What is this clinical trial studying?
An observational study of Atherosclerosis and Cardiovascular Diseases, run by University of Michigan.
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 11 Apr 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.
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 11 Apr 2016.