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Inflammation, Infection, and Future Cardiovascular Risk

This study has been completed.
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI) Identifier:
First received: May 25, 2000
Last updated: March 15, 2016
Last verified: February 2005
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).

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

Resource links provided by NLM:

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: September 1998
Study Completion Date: August 2002
Detailed Description:


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.


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.


Ages Eligible for Study:   up to 100 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
No eligibility criteria
  Contacts and Locations
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Please refer to this study by its identifier: NCT00005496

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

Publications: Identifier: NCT00005496     History of Changes
Other Study ID Numbers: 5014
R01HL058755 ( U.S. NIH Grant/Contract )
Study First Received: May 25, 2000
Last Updated: March 15, 2016

Additional relevant MeSH terms:
Communicable Diseases
Cardiovascular Diseases
Heart Diseases
Myocardial Infarction
Venous Thromboembolism
Coronary Disease
Coronary Artery Disease
Cytomegalovirus Infections
Helicobacter Infections
Chlamydia Infections
Herpesviridae Infections
Pathologic Processes
Myocardial Ischemia
Vascular Diseases
Embolism and Thrombosis
Arterial Occlusive Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
DNA Virus Infections
Virus Diseases processed this record on July 27, 2017