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Sponsored by: |
National Heart, Lung, and Blood Institute (NHLBI) |
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Information provided by: | National Heart, Lung, and Blood Institute (NHLBI) |
ClinicalTrials.gov Identifier: | NCT00005547 |
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.
Condition |
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Cardiovascular Diseases Coronary Disease Cerebrovascular Accident Heart Diseases Myocardial Infarction Infection Chlamydia Infections Cytomegalovirus Infections Helicobacter Infections Atherosclerosis |
Study Type: | Observational |
Study Design: | Natural History, Defined Population |
Study Start Date: | April 1999 |
Estimated Study Completion Date: | June 2003 |
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.
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
No eligibility criteria
Study ID Numbers: | 5091 |
Study First Received: | May 25, 2000 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00005547 History of Changes |
Health Authority: | United States: Federal Government |
Atherosclerosis Bacterial Infections Cerebral Infarction Myocardial Ischemia Arteriosclerosis Helicobacter Infections Brain Diseases Cytomegalovirus Cerebrovascular Disorders Gram-Negative Bacterial Infections Genital Diseases, Female Necrosis Chlamydia Infections Cytomegalic Inclusion Disease Brain Ischemia |
Cytomegalovirus Infections Myocardial Infarction Arterial Occlusive Diseases Heart Diseases Stroke Vascular Diseases Central Nervous System Diseases Ischemia Genital Diseases, Male Herpesviridae Infections Coronary Disease Virus Diseases Sexually Transmitted Diseases DNA Virus Infections Brain Infarction |
Atherosclerosis Bacterial Infections Communicable Diseases Sexually Transmitted Diseases, Bacterial Cerebral Infarction Myocardial Ischemia Helicobacter Infections Arteriosclerosis Brain Diseases Infection Cerebrovascular Disorders Gram-Negative Bacterial Infections Genital Diseases, Female Necrosis Pathologic Processes |
Chlamydiaceae Infections Chlamydia Infections Brain Ischemia Cytomegalovirus Infections Cardiovascular Diseases Myocardial Infarction Arterial Occlusive Diseases Heart Diseases Nervous System Diseases Stroke Vascular Diseases Central Nervous System Diseases Ischemia Genital Diseases, Male Herpesviridae Infections |