Family Heart Study - Subclinical Atherosclerosis Network (FHS-SCAN)
NCT ID: NCT00024596
Last Updated: 2015-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
3389 participants
OBSERVATIONAL
2001-09-30
2006-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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FAMILY_BASED
CROSS_SECTIONAL
Study Groups
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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.
No interventions assigned to this group
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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
100 Years
ALL
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
Washington University School of Medicine
OTHER
Responsible Party
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Michael Province
Professor of Genetics and Biostatistics
Principal Investigators
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John Carr
Role:
Wake Forest University
John Eckfeldt
Role:
University of Minnesota
R. Ellison
Role:
Boston University
Gerardo Heiss
Role:
University of North Carolina
James Hixson
Role:
University of Texas
Steven Hunt
Role:
University of Utah
Cora Lewis
Role:
University of Alabama at Birmingham
James Pankow
Role:
University of Minnesota
Michael Province
Role:
Washington University School of Medicine
Lynne Wagenknecht
Role:
Wake Forest University
References
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Djousse L, Arnett DK, Carr JJ, Eckfeldt JH, Hopkins PN, Province MA, Ellison RC; Investigators of the NHLBI FHS. Dietary linolenic acid is inversely associated with calcified atherosclerotic plaque in the coronary arteries: the National Heart, Lung, and Blood Institute Family Heart Study. Circulation. 2005 Jun 7;111(22):2921-6. doi: 10.1161/CIRCULATIONAHA.104.489534. Epub 2005 May 31.
Ellison RC, Zhang Y, Wagenknecht LE, Eckfeldt JH, Hopkins PN, Pankow JS, Djousse L, Carr JJ. Relation of the metabolic syndrome to calcified atherosclerotic plaque in the coronary arteries and aorta. Am J Cardiol. 2005 May 15;95(10):1180-6. doi: 10.1016/j.amjcard.2005.01.046.
Other Identifiers
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985
Identifier Type: -
Identifier Source: org_study_id