Cardiovascular DiseasesNCT00081679
SES, Health Behaviors and CVD Among Vietnam-Era Twins
An observational study of Cardiovascular Diseases and Heart Diseases, run by The Miriam Hospital.
Trial summary
To further characterize the nature of the association between socioeconomic status (SES), health behaviors and early cardiovascular disease in the Vietnam Era Twin (VET) Registry, a sample of over 4,000 twin pairs. Read more about this study
- Who is it for?
- Ages 45 to 65 years, men only
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Jun 2004to May 2007
- 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 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
No eligibility criteria
About this study
To further characterize the nature of the association between socioeconomic status (SES), health behaviors and early cardiovascular disease in the Vietnam Era Twin (VET) Registry, a sample of over 4,000 twin pairs.
Read the detailed description
BACKGROUND:
Cardiovascular disease (CVD) affects approximately 60,800,000 Americans each year, claiming the lives of nearly one million of these people (American Heart Association, 2001). CVD is likely to be complex in etiology, reflecting the combined effect of both genes and environment, as well as gene x gene and gene x environment interaction. Examination of environmental factors thought to affect CVD risk in the context of a genetically informative design can help elucidate the relative contribution of genetic and environmental factors and potentially aid in identifying environmental factors that may interact with genetic vulnerability in predicting CVD. Cardiovascular morbidity and mortality are over-represented among individuals in lower socioeconomic strata, as are behaviors that increase the likelihood of cardiovascular events, including smoking, heavy alcohol consumption and physical inactivity (Adler et al., 1994; Anderson \& Armstead, 1995). Thus, it is commonly assumed that socioeconomic status (SES) serves as an important environmental influence on health and health behaviors. Twin studies partition genetic and environmental variance and detect gene x environment interaction and provide a unique opportunity to study the association between SES and health.
DESIGN NARRATIVE:
The study will characterize the nature of the association between socioeconomic status (SES), health behaviors and cardiovascular disease (CVD) in the existing Vietnam Era Twin (VET) registry, a sample of over 4000 male twin pairs with a mean age of 51 in 1999. Specifically, the study will: 1) determine how strongly environmental factors contribute to individual differences in SES, health behaviors and CVD, relative to genetic factors; 2) examine whether measures of SES are associated with health behaviors and CVD mortality when controlling for concomitant genetic influences; and 3) investigate whether SES interacts with genetic vulnerabilities to predict health behaviors and CVD (gene x environment interaction). Using VETdatasets, the primary method of analysis will be twin structural equation modeling.
- Conditions
- Cardiovascular Diseases, Heart Diseases
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2004 (estimated)
- Study startJun 2004
- Primary completionMay 2007
- Study completionMay 2007
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.
- 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
Sponsor and investigators
- Lead sponsor
- The Miriam Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Investigators
- Jeanne McCaffery, The Miriam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00081679
- Sponsor's protocol ID
- 1247
- Other IDs
- R01HL072819
- Status last verified
- Jan 2008
- First submitted
- 19 Apr 2004
- Last updated
- 16 Apr 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SES, Health Behaviors and CVD Among Vietnam-Era Twins
- ClinicalTrials.gov ID
- NCT00081679
- Acronym / sponsor ID
- 1247
- Conditions
- Cardiovascular Diseases, Heart Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- The Miriam HospitalUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jun 2004
- Primary completion
- May 2007 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 21 Apr 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 further characterize the nature of the association between socioeconomic status (SES), health behaviors and early cardiovascular disease in the Vietnam Era Twin (VET) Registry, a sample of over 4,000 twin pairs.
Detailed description
BACKGROUND:
Cardiovascular disease (CVD) affects approximately 60,800,000 Americans each year, claiming the lives of nearly one million of these people (American Heart Association, 2001). CVD is likely to be complex in etiology, reflecting the combined effect of both genes and environment, as well as gene x gene and gene x environment interaction. Examination of environmental factors thought to affect CVD risk in the context of a genetically informative design can help elucidate the relative contribution of genetic and environmental factors and potentially aid in identifying environmental factors that may interact with genetic vulnerability in predicting CVD. Cardiovascular morbidity and mortality are over-represented among individuals in lower socioeconomic strata, as are behaviors that increase the likelihood of cardiovascular events, including smoking, heavy alcohol consumption and physical inactivity (Adler et al., 1994; Anderson \& Armstead, 1995). Thus, it is commonly assumed that socioeconomic status (SES) serves as an important environmental influence on health and health behaviors. Twin studies partition genetic and environmental variance and detect gene x environment interaction and provide a unique opportunity to study the association between SES and health.
DESIGN NARRATIVE:
The study will characterize the nature of the association between socioeconomic status (SES), health behaviors and cardiovascular disease (CVD) in the existing Vietnam Era Twin (VET) registry, a sample of over 4000 male twin pairs with a mean age of 51 in 1999. Specifically, the study will: 1) determine how strongly environmental factors contribute to individual differences in SES, health behaviors and CVD, relative to genetic factors; 2) examine whether measures of SES are associated with health behaviors and CVD mortality when controlling for concomitant genetic influences; and 3) investigate whether SES interacts with genetic vulnerabilities to predict health behaviors and CVD (gene x environment interaction). Using VETdatasets, the primary method of analysis will be twin structural equation modeling.
Study design
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 16 Apr 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.
Jeanne McCaffery
The Miriam Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Heart Diseases, run by The Miriam Hospital.
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 16 Apr 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.
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 16 Apr 2014.