Genetic Epidemiology of Change in CVD Risk Factors

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00037440
• Other study ID #: 1171
• Secondary ID: R01HL070568
• Status: Completed
• Phase: N/A
• First received: May 16, 2002
• Last updated: December 1, 2014
• Start date: September 2001
• Est. completion date: August 2005

Study information

• Verified date: December 2014
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1735
• Est. completion date: August 2005
• Est. primary completion date: August 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 8 Years to 38 Years

Eligibility

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

Study Design

Observational Model: Ecologic or Community, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Heart Diseases

Intervention

Genetic:
• Polymorphisms measured

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	National Heart, Lung, and Blood Institute (NHLBI)

References & Publications (1)

Hallman DM, Srinivasan SR, Chen W, Boerwinkle E, Berenson GS. The beta(2)-adrenergic receptor Arg16-gly polymorphism and interactions involving beta(2)- and beta(3)-adrenergic receptor polymorphisms are associated with variations in longitudinal serum lipid profiles: the Bogalusa Heart Study. Metabolism. 2004 Sep;53(9):1184-91. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma lipid levels		Change from 8 - 18 years of age	No