Genetic Epidemiology of Change in CVD Risk Factors

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Michael Hallman, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT00037440
First received: May 16, 2002
Last updated: December 1, 2014
Last verified: December 2014
  Purpose

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.


Condition Intervention
Cardiovascular Diseases
Heart Diseases
Genetic: Polymorphisms measured

Study Type: Observational
Study Design: Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Genetic Epidemiology of Change in CVD Risk Factors (HL70568-1)

Further study details as provided by The University of Texas Health Science Center, Houston:

Primary Outcome Measures:
  • Plasma lipid levels [ Time Frame: Change from 8 - 18 years of age ] [ Designated as safety issue: No ]

Enrollment: 1735
Study Start Date: September 2001
Study Completion Date: August 2005
Primary Completion Date: August 2005 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
Genetic: Polymorphisms measured
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.
Genetic: Polymorphisms measured

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.

  Eligibility

Ages Eligible for Study:   8 Years to 38 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

Criteria

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

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00037440

Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
Principal Investigator: David Hallman The University of Texas Health Science Center, Houston
  More Information

Publications:
Responsible Party: Michael Hallman, Assistant Professor, Epidemiology and Disease Control, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT00037440     History of Changes
Other Study ID Numbers: 1171, R01HL070568
Study First Received: May 16, 2002
Last Updated: December 1, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 26, 2015