Family Heart Study - Subclinical Atherosclerosis Network (FHS-SCAN)

This study has been completed.
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Michael Province, Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00024596
First received: September 21, 2001
Last updated: December 21, 2015
Last verified: December 2015
  Purpose
To determine familial and non-familial causes for susceptibility to atherosclerosis and the inflammatory response.

Condition
Cardiovascular Diseases
Heart Diseases
Atherosclerosis
Coronary Arteriosclerosis

Study Type: Observational
Study Design: Observational Model: Family-Based
Time Perspective: Cross-Sectional

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Biospecimen Retention:   Samples With DNA
Stored DNA, lymphoblasts

Enrollment: 3389
Study Start Date: September 2001
Study Completion Date: August 2006
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
Groups/Cohorts
Caucasian Families
Largest 3-generational Caucasian Families from Family Heart Study (Classic) with average family size of 10 N=2767 Subjects from 512 families. Approximately half are random sample families from FamHS-Classic, and half are high-familial CHD risk families from FamHS-Classic. 4 Field sites were Raleigh-Durham North Carolina; Minneapolis, MN; Framingham MA; and Salt Lake City, UT.
African-American Families
622 subjects from 2-3 generational 212 African-American families originally recruited from the HyperGEN study in Birmingham AL. These are hypertension enriched families.

Detailed Description:

BACKGROUND:

Atherosclerotic cardiovascular disease, along with its related health expenditures, mortality, and morbidity, remains among the most significant health-related conditions in the United States and other developed countries. The substantial resources that have been expended to investigate this problem have led to significant scientific advances in the basic biology, clinical management, epidemiology, and public health intervention approaches. Despite these real advances, there remains much more to be done in terms of understanding the basic biological and social processes, treatment, and public health programs.

Just as earlier research was effective in identifying a variety of epidemiologic risk factors for cardiovascular disease, recent advances make it possible to bring to bear a variety of new and powerful tools to detailed study of the basic processes involved in atherogenesis. Application of these tools, in combination with synthesis of prior basic and epidemiologic results, provides a powerful approach that is more model-driven than many previous studies.

DESIGN NARRATIVE:

The Subclinical Atherosclerosis Network is a multicenter study of the genetic epidemiology of coronary and aortic calcification and of inflammatory markers. It examines two areas of great interest in contemporary vascular medicine, namely vascular calcification and inflammation in approximately 3000 persons who have been recruited to the Family Heart Study, with additional persons of African American descent contributed by the HyperGEN Study. Considerable data, including a large number of genotypes, have been collected in the Family Heart Study. The subjects will be brought back for additional data collection, including the measurement of inflammatory markers and coronary and aortic calcification by computed tomography (CT).

The network will quantify coronary and aortic artery calcium volume in 441 selected, informative pedigrees ( approximately 3,000 individuals) previously examined and extensively genotyped ( approximately 400 markers spanning the genome) by the NHLBI Family Heart Study, in order to identify genes associated with human atherosclerosis. An additional 275 African American sibships (approximately 600 individuals, also examined and comparably genotyped) will be included to address these study questions in this high-risk population. Assessment of the inter-individual variability in the inflammatory burden and the host response, and the extensive metabolic, behavioral, and environmental data already collected on these pedigrees will provide enhanced phenotypic homogeneity and increased analytic power in assessing the genetic basis of atherosclerosis.

State of the art laboratory and statistical methods will be used to find, localize and characterize the influence of predisposing genes to atherosclerosis and the inflammatory response. Novel genetic analysis methods will be used to address the issues of phenotypic, genetic and population heterogeneity, epistasis, complex interactions among the genetic and environmental risk factors, and to optimize the detection of genomic regions affecting phenotypic susceptibility.

  Eligibility

Ages Eligible for Study:   up to 100 Years   (Child, Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
No eligibility criteria
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00024596

Sponsors and Collaborators
Washington University School of Medicine
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
OverallOfficial: John Carr Wake Forest University
OverallOfficial: John Eckfeldt University of Minnesota, MN
OverallOfficial: R. Ellison Boston University
OverallOfficial: Gerardo Heiss University of North Carolina
OverallOfficial: James Hixson University of Texas
OverallOfficial: Steven Hunt University of Utah
OverallOfficial: Cora Lewis University of Alabama at Birmingham
OverallOfficial: James Pankow University of Minnesota, MN
OverallOfficial: Michael Province Washington University School of Medicine
OverallOfficial: Lynne Wagenknecht Wake Forest University
  More Information

Publications:
Responsible Party: Michael Province, Professor of Genetics and Biostatistics, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00024596     History of Changes
Other Study ID Numbers: 985  R01HL088215 
Study First Received: September 21, 2001
Last Updated: December 21, 2015
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Cardiovascular Diseases
Heart Diseases
Atherosclerosis
Arteriosclerosis
Coronary Artery Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Vascular Diseases
Coronary Disease

ClinicalTrials.gov processed this record on August 25, 2016