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Inflammation, Infection, and Future Cardiovascular Risk

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ClinicalTrials.gov Identifier: NCT00005496
Recruitment Status : Completed
First Posted : May 26, 2000
Last Update Posted : March 16, 2016
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)

Brief Summary:
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 or disease
Cardiovascular Diseases Coronary Disease Cerebrovascular Accident Myocardial Infarction Venous Thromboembolism Heart Diseases Infection Chlamydia Infections Cytomegalovirus Infections Helicobacter Infections Herpesviridae Infections Inflammation

Detailed Description:

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.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.


Study Type : Observational
Study Start Date : September 1998
Actual Study Completion Date : August 2002

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U.S. FDA Resources





Information from the National Library of Medicine

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Ages Eligible for Study:   up to 100 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria
No eligibility criteria

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00005496


Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
OverallOfficial: Paul Ridker Brigham and Women's Hospital

Publications:

ClinicalTrials.gov Identifier: NCT00005496     History of Changes
Other Study ID Numbers: 5014
R01HL058755 ( U.S. NIH Grant/Contract )
First Posted: May 26, 2000    Key Record Dates
Last Update Posted: March 16, 2016
Last Verified: February 2005

Additional relevant MeSH terms:
Infection
Communicable Diseases
Inflammation
Infarction
Cardiovascular Diseases
Heart Diseases
Myocardial Infarction
Thromboembolism
Venous Thromboembolism
Coronary Disease
Coronary Artery Disease
Stroke
Cytomegalovirus Infections
Helicobacter Infections
Chlamydia Infections
Herpesviridae Infections
Pathologic Processes
Ischemia
Necrosis
Myocardial Ischemia
Vascular Diseases
Embolism and Thrombosis
Arteriosclerosis
Arterial Occlusive Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
DNA Virus Infections
Virus Diseases