Examining the Link Between Trace Elements and Cardiovascular Disease Risk Factors in Young Adults

April 15, 2016 updated by: University of North Carolina, Chapel Hill

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

4362

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599-7461
        • University of North Carolina at Chapel Hill

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 32 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participating in the CARDIA study.

Description

Inclusion Criteria:

  • Enrolled in the CARDIA study; this current study will be using existing CARDIA study data and will not be recruiting any new participants

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
CVD risk factors
Time Frame: 1987-2010
1987-2010

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina, Chapel Hill

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Ka He, MD, University of North Carolina, Chapel Hill

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Primary Completion (Actual)

April 1, 2011

Study Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

April 25, 2006

First Submitted That Met QC Criteria

April 25, 2006

First Posted (Estimate)

April 27, 2006

Study Record Updates

Last Update Posted (Estimate)

April 19, 2016

Last Update Submitted That Met QC Criteria

April 15, 2016

Last Verified

December 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1335
  • R01HL081572-01A1 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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