Genetic Epidemiology of Change in CVD Risk Factors

December 1, 2014 updated by: Michael Hallman, The University of Texas Health Science Center, Houston

Genetic Epidemiology of Change in CVD Risk Factors (HL70568-1)

To extend knowledge of the genetic factors affecting the course of cardiovascular disease risk factor development over a substantial portion of an individual's lifetime.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

BACKGROUND:

While the onset of symptomatic cardiovascular disease (CVD) typically occurs in middle age or later, the development of the underlying pathology is clearly a long-term process, and early-state lesions having been identified at autopsy even in children. Understanding the course of CVD risk development from childhood into middle age will clearly be valuable both in understanding the pathology of CVD and in targeting preventive measures most effectively. Furthermore, while genetic factors are agreed to play a significant role in the development of CVD, most genes contributing to interindividual variation in CVD risk will have relatively small effects on risk for any given individual, even though their aggregate effects contribute significantly to CVD risk in the overall population. Relatively little is known about the effects of genetic variants on the course of CVD risk factor development in individuals over time. The Bogalusa Heart Study (BHS), which began in 1973 as a study of CVD risk factors in children but evolved to cover the development of CVD risk factors from childhood into early middle age, offers an unparalleled resource for investigating the genetic factors influencing within-individual changes over time in quantitative factors, such as serum lipids and blood pressure, related to CVD risk.

DESIGN NARRATIVE:

Approximately 1500 individuals who were examined in the BHS on at least three separate occasions over a period of up to 20 years, and who consented to participate in studies of genetic factors influencing CVD risk, will have genotypes measured at selected loci either known or strongly suspected to affect interindividual variation in CVD risk. Longitudinal multilevel regression will be used to measure the effects of variation at these loci on quantitative CVD risk factor profiles within individuals and to determine whether some gene effects on CVD risk variation are age-dependent.

Study Type

Observational

Enrollment (Actual)

1735

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

8 years to 38 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Community study of schoolchildren in Bogalusa, Louisiana, with follow-up into young adulthood. Both whites and African Americans recruited.

Description

Schoolchildren from Bogalusa, Louisiana. All children in Bogalusa public schools were eligible.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
BHS Whites
Whites from Bogalusa, Louisiana; initially recruited as schoolchildren and followed at irregular intervals (about 3 years apart on average) into adolescence and early adulthood. There were no interventions of any kind-- this was an observational study only.
BHS African Americans
African Americans from Bogalusa, Louisiana, initially recruited as schoolchildren and followed at irregular intervals (about 3 years apart on average) into adolescence and early adulthood. There were no interventions of any kind-- this was an observational study only.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Plasma lipid levels
Time Frame: Change from 8 - 18 years of age
Change from 8 - 18 years of age

Collaborators and Investigators

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

Investigators

  • Principal Investigator: David Hallman, The University of Texas Health Science Center, Houston

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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

September 1, 2001

Primary Completion (Actual)

August 1, 2005

Study Completion (Actual)

August 1, 2005

Study Registration Dates

First Submitted

May 16, 2002

First Submitted That Met QC Criteria

May 16, 2002

First Posted (Estimate)

May 17, 2002

Study Record Updates

Last Update Posted (Estimate)

December 3, 2014

Last Update Submitted That Met QC Criteria

December 1, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1171 (Comité d'Ethique de la Recherche Biomédicale (CERB))
  • R01HL070568 (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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