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

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ClinicalTrials.gov Identifier: NCT00024596
Recruitment Status : Completed
First Posted : September 21, 2001
Last Update Posted : December 22, 2015
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Michael Province, Washington University School of Medicine

September 21, 2001
September 21, 2001
December 22, 2015
September 2001
August 2006   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00024596 on ClinicalTrials.gov Archive Site
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Family Heart Study - Subclinical Atherosclerosis Network (FHS-SCAN)
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To determine familial and non-familial causes for susceptibility to atherosclerosis and the inflammatory response.

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.

Observational
Observational Model: Family-Based
Time Perspective: Cross-Sectional
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Retention:   Samples With DNA
Description:
Stored DNA, lymphoblasts
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  • Cardiovascular Diseases
  • Heart Diseases
  • Atherosclerosis
  • Coronary Arteriosclerosis
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  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3389
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August 2006
August 2006   (Final data collection date for primary outcome measure)
No eligibility criteria
Sexes Eligible for Study: All
up to 100 Years   (Child, Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
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NCT00024596
985
R01HL088215 ( U.S. NIH Grant/Contract )
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Michael Province, Washington University School of Medicine
Washington University School of Medicine
National Heart, Lung, and Blood Institute (NHLBI)
Investigator: John Carr Wake Forest University
Investigator: John Eckfeldt University of Minnesota, MN
Investigator: R. Ellison Boston University
Investigator: Gerardo Heiss University of North Carolina
Investigator: James Hixson University of Texas
Investigator: Steven Hunt University of Utah
Investigator: Cora Lewis University of Alabama at Birmingham
Investigator: James Pankow University of Minnesota, MN
Investigator: Michael Province Washington University School of Medicine
Investigator: Lynne Wagenknecht Wake Forest University
Washington University School of Medicine
December 2015