Cardiovascular DiseasesNCT00318734
Examining the Link Between Trace Elements and Cardiovascular Disease Risk Factors in Young Adults
An observational study of Cardiovascular Diseases and Metabolic Syndrome X, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
Cardiovascular disease (CVD) affects millions of people in the United States; each year, more people die from CVD than from any other disease. There are many dietary and lifestyle factors that may increase the risk of developing CVD. Read more about this study
- Who is it for?
- Ages 20 to 32 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Metabolic Syndrome X, Hypertension
- How many people
- 4,362 participants
- Where
- 1 siteUnited States
- Study dates
- May 2006to Apr 2011
- 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 20 to 32 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Participating in the CARDIA study.
Who may be able to join
- Enrolled in the CARDIA study; this current study will be using existing CARDIA study data and will not be recruiting any new participants
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599-7461
About this study
Official title: Trace Elements and CVD Risk Factors Among Young Adults
Cardiovascular disease (CVD) affects millions of people in the United States; each year, more people die from CVD than from any other disease. There are many dietary and lifestyle factors that may increase the risk of developing CVD. Preliminary research has shown that the presence of certain trace elements may be associated with the development of CVD. This study will examine toenail clippings and laboratory data to evaluate the link between trace elements and CVD risk factors in young adults.
Read the detailed description
CVD is a disorder that affects the heart's ability to function normally. The most common cause of heart disease is narrowing or blockage of the coronary arteries, which supply blood to the heart. There are many risk factors for CVD, including inflammation, high blood pressure, high cholesterol, and obesity. Small quantities of trace elements, also known as micronutrients, are essential in maintaining a healthy body. Research has shown that some trace elements may be associated with the development of CVD, but more research is needed to confirm this connection. This study will examine concentrations of several trace elements in toenail samples of young adults participating in the Coronary Artery Risk Development in Young Adults (CARDIA) study. The CARDIA study is measuring changes in CVD risk factors in individuals as they age and is identifying lifestyle habits that influence those changes. The purpose of this study is to determine the link between trace elements and CVD risk factors in young adults. The results of this study may help to identify whether dietary, lifestyle, or environmental factors can be modified at a young age to prevent the development of CVD.
This study will examine laboratory and medical history data of participants who are already enrolled in the CARDIA study; there are no additional study visits specifically for this study. Toenail samples collected from participants during their Year 2 CARDIA study visit in the late 1980's will be examined to determine the presence of selenium, chromium, arsenic, and mercury. Participants' CARDIA study data will be reviewed and several CVD risk factors will be analyzed, including the thickness of heart arteries; calcium buildup within the arteries; inflammatory markers, such as high sensitivity C-reactive protein and interleukin 6; blood pressure levels; body weight; and levels of cholesterol, fat, and sugar.
- Conditions
- Cardiovascular Diseases, Metabolic Syndrome X, Hypertension, Inflammation, Atherosclerosis
- Medical subject headings
- Cardiovascular Diseases, Metabolic Syndrome, Hypertension, Inflammation, Atherosclerosis
What is being measured
The primary outcome is the main question the study is designed to answer.
CVD risk factors
Measured: 1987-2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2006 (estimated)
- Study startMay 2006
- Primary completionApr 2011
- Study completionApr 2011
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 North Carolina, Chapel HillThe 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
- 4,362 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Ka He, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00318734
- Sponsor's protocol ID
- 1335
- Other IDs
- R01HL081572-01A1
- Status last verified
- Dec 2011
- First submitted
- 25 Apr 2006
- Last updated
- 19 Apr 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trace Elements and CVD Risk Factors Among Young Adults
- ClinicalTrials.gov ID
- NCT00318734
- Acronym / sponsor ID
- 1335
- Conditions
- Cardiovascular Diseases, Metabolic Syndrome X, Hypertension, Inflammation, Atherosclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,362 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- May 2006
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 27 Apr 2006 (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.
Cardiovascular disease (CVD) affects millions of people in the United States; each year, more people die from CVD than from any other disease. There are many dietary and lifestyle factors that may increase the risk of developing CVD. Preliminary research has shown that the presence of certain trace elements may be associated with the development of CVD. This study will examine toenail clippings and laboratory data to evaluate the link between trace elements and CVD risk factors in young adults.
Detailed description
CVD is a disorder that affects the heart's ability to function normally. The most common cause of heart disease is narrowing or blockage of the coronary arteries, which supply blood to the heart. There are many risk factors for CVD, including inflammation, high blood pressure, high cholesterol, and obesity. Small quantities of trace elements, also known as micronutrients, are essential in maintaining a healthy body. Research has shown that some trace elements may be associated with the development of CVD, but more research is needed to confirm this connection. This study will examine concentrations of several trace elements in toenail samples of young adults participating in the Coronary Artery Risk Development in Young Adults (CARDIA) study. The CARDIA study is measuring changes in CVD risk factors in individuals as they age and is identifying lifestyle habits that influence those changes. The purpose of this study is to determine the link between trace elements and CVD risk factors in young adults. The results of this study may help to identify whether dietary, lifestyle, or environmental factors can be modified at a young age to prevent the development of CVD.
This study will examine laboratory and medical history data of participants who are already enrolled in the CARDIA study; there are no additional study visits specifically for this study. Toenail samples collected from participants during their Year 2 CARDIA study visit in the late 1980's will be examined to determine the presence of selenium, chromium, arsenic, and mercury. Participants' CARDIA study data will be reviewed and several CVD risk factors will be analyzed, including the thickness of heart arteries; calcium buildup within the arteries; inflammatory markers, such as high sensitivity C-reactive protein and interleukin 6; blood pressure levels; body weight; and levels of cholesterol, fat, and sugar.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 32 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Participating in the CARDIA study.
Key inclusion criteria (1 listed)
- Enrolled in the CARDIA study; this current study will be using existing CARDIA study data and will not be recruiting any new participants
Key exclusion criteria (0 listed)
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
CVD risk factors
Time frame: 1987-2010
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 19 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.
Ka He, MD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Metabolic Syndrome X, run by University of North Carolina, Chapel Hill at 1 site in United States.
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 1 inclusion and 0 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 19 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
CVD risk factors (time frame: 1987-2010). 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 19 Apr 2016.