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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: | NCT00005496 |
To examine markers of underlying chronic inflammation and infection as potential risk factors for future myocardial infarction (MI), stroke (CVA), and venous thromboembolism (VTE) in plasma samples collected at baseline from healthy participants in the Physicians' Health Study (PHS).
Condition |
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Cardiovascular Diseases Coronary Disease Cerebrovascular Accident Myocardial Infarction Venous Thromboembolism Heart Diseases Infection Chlamydia Infections Cytomegalovirus Infections Helicobacter Infections Herpesviridae Infections Inflammation |
Study Type: | Observational |
Study Design: | Natural History, Case Control |
Study Start Date: | September 1998 |
Estimated Study Completion Date: | August 2002 |
BACKGROUND:
The PHS is a cohort which included 14,916 men initially free of cardiovascular disease and cancer who provided plasma samples at study entry in 1982. These men were randomly assigned in a factorial design to aspirin or beta-carotene therapy, and have been followed prospectively for the occurrence of vascular disease.
DESIGN NARRATIVE:
Employing a nested case-control design, baseline plasma samples are assayed for four markers of inflammation (interleukin-6, TNF-alpha, soluble ICAM, soluble VCAM) and four markers of chronic infection (antibody titers directed against Chlamydia pneumoniae, Helicobacter pylori, Herpes simplex virus, and cytomegalovirus). Case subjects are those study participants who have subsequently developed MI (N=550), CVA (N=400), or VTE (N=200).
Control subjects are selected from those study participants who remained healthy during follow-up and are matched to the cases by age, smoking status, and follow-up time. Data on usual cardiovascular risk factors, lipid parameters, and hemostatic markers of risk are already available in the PHS and will be used to evaluate the results for potential confounding and effect modification. Since the PHS was a randomized trial of low-dose aspirin for its initial 5 years, this cohort also provides the unique opportunity to investigate whether the use of an agent with anti-inflammatory properties modifies the risk of subsequent thrombosis among those with underlying inflammation. Indeed, this intriguing hypothesis has recently been raised regarding data relating another marker of inflammation, C-reactive protein, to future risks of myocardial infarction and stroke.
These analyses will take advantage of an existing blood bank from a well-characterized large cohort with many years of follow-up and high quality end-point verification. Thus, this study could provide an efficient and cost-effective mechanism to evaluate the posited, but unproven roles of inflammation and infection as risk factors for future cardiovascular disease.
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
No eligibility criteria
Study ID Numbers: | 5014 |
Study First Received: | May 25, 2000 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00005496 History of Changes |
Health Authority: | United States: Federal Government |
Bacterial Infections Cerebral Infarction Myocardial Ischemia Helicobacter Infections Arteriosclerosis Brain Diseases Cytomegalovirus Cerebrovascular Disorders Thromboembolism 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 Venous Thromboembolism Genital Diseases, Male Thrombosis Herpesviridae Infections Inflammation Virus Diseases Coronary Disease |
Bacterial Infections Communicable Diseases Sexually Transmitted Diseases, Bacterial Cerebral Infarction Myocardial Ischemia Arteriosclerosis Helicobacter Infections Brain Diseases Infection Cerebrovascular Disorders Thromboembolism 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 Venous Thromboembolism Genital Diseases, Male |