Cardiovascular Diseases Clinical Trial
To investigate the relationship between genetic variation in genes for inflammation and carotid artery atherosclerosis.
BACKGROUND:
Atherosclerotic vascular disease is a major source of morbidity and mortality. Inflammation
plays an important role in atherosclerosis. The tools to systematically study the extent to
which genetic variation determines risk of and progression of atherosclerosis are only now
becoming available.
DESIGN NARRATIVE:
The study will evaluate the role of genetic variation in inflammatory pathway genes at 29
loci on the risk and progression of carotid artery atherosclerotic disease (CAAD). Genes to
be evaluated include those potentially involved in plaque initiation and progression. The
investigators will evaluate single nucleotide polymorphisms (SNPs) informative for the
common locus haplotypes. Choice of informative polymorphisms for evaluation is based on the
genes' evolutionary history. They will evaluate progression effects in subjects with CAAD
followed longitudinally by noninvasive magnetic resonance (MR) techniques over 3 years. Risk
will be evaluated by case-control comparisons. In additions to evaluating genetic
polymorphisms, they will evaluate the intervening phenotypes of protein level for
fibrinogen, C-reactive protein, serum amyloid A, and interleukin-6. Independence of genetic
predictors from traditional cardiovascular risk factors will be evaluated.
The major specific aims are: Aim 1. Test for inflammatory genetic effects and protein level
in CAAD progression in 550 subjects with CAAD (275 with 15-49% and 275 with 50-79% baseline
CAAD stenosis) evaluated by 3-year magnetic resonance image follow-up of percent lumen
stenosis; Aim 2. Determine whether the variation in the inflammatory genes or protein levels
predicts 810 case vs. 810 control status with a case distribution of 335 subject with
15-49%, 275 with 50-75% and 200 with >80% carotid artery stenosis at baseline. Age (onset of
vascular disease for cases, current age for controls)-, sex-, race-, and hospital-matched
controls will have less than 15% stenosis on carotid duplex ultrasound. Genes that are
implicated in disease may eventually allow targeted therapy.
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N/A
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