Cardiovascular Diseases Clinical Trial
To investigate the role of chronic infection as a risk factor for vascular disease in a study of Native Americans. The primary focus is on the two most common agents Chlamydia pneumoniae and cytomegalovirus with a secondary emphasis on Helicobacter pylori.
BACKGROUND:
Recent studies have associated evidence of Chlamydia pneumoniae infection with coronary and
carotid atherosclerosis and evidence of increased infection with cytomegalovirus (CMV) in
patients developing restenosis or with atherosclerosis. Several other common pathogens have
been less consistently associated with atherosclerosis. Altered parameters of inflammation
and hemostasis have been identified as prognostic factors of myocardial infarction and have
been linked as possible pathogenetic mechanisms. Recent studies have indicated that
peripheral blood mononuclear cells (PBMC) from patients with coronary artery disease
frequently include Chlamydia pneumoniae DNA and stimulation of PBMCs can reflect an
unsuccessful host cellular immune response to CMV associated with elevated C-reactive
protein (CRP).
DESIGN NARRATIVE:
The study has both a nested case-control design and a nested cohort design within the Strong
Heart Study (SHS), an ongoing cohort study of 4,549 American Indians. The study utilizes
previously collected specimens, baseline data, and the ultrasound measurement of carotid
wall thickness (IMT) in SHS participants. Within the initial SHS cohort, 400 definite cases
of incident myocardial infarction, coronary heart disease, and stroke are compared with 400
control individuals with no such diagnoses and matched for age, gender, and residence. Their
prior serum specimens are analyzed for Chlamydia pneumoniae-specific IgG, IgM antibody, for
cytomegalovirus-specific IgG antibody, and for C-reactive protein (CRP). In addition, assays
are performed for antibodies to Helicobacter pylori, hepatitis A virus, (HAV) and herpes
simplex virus (HSV) type 1 and 2. Correlations are made with baseline parameters of lipids,
coagulation, and adjusted for potential confounding variables of tobacco use, pneumonia, and
altered pulmonary function. An additional analysis of a subcohort, the above 400 controls,
is performed looking at the outcome of their carotid IMT, a parameter of subclinical
atherosclerosis, in relation to serologic results indicating a prior exposure to CMV,
Chlamydia pneumoniae, and/or other pathogens approximately eight years preceding ultrasound
testing. Both case-control and cohort analysis are stratified by levels of hemostasis and
inflammation, including CRP, fibrinogen, Lp(a), and plasminogen-activator inhibitor-1. A
separate nested substudy performed on peripheral blood mononuclear cells (PBMCs),
prospectively collected from 80 cases and 80 controls, examines the host T-cell
proliferative response to CMV and other pathogens in relation to disease and also searches
for a chronic persistent infection with Chlamydia pneumoniae evidence by DNA detection.
The study completion date listed in this record was obtained from the "End Date" entered in
the Protocol Registration and Results System (PRS) record.
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