Inflammation, Infection, and Future Cardiovascular Risk

March 15, 2016 updated by: National Heart, Lung, and Blood Institute (NHLBI)
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).

Study Overview

Status

Completed

Conditions

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 100 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

No eligibility criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Paul Ridker, Brigham and Women's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 1998

Study Completion (Actual)

August 1, 2002

Study Registration Dates

First Submitted

May 25, 2000

First Submitted That Met QC Criteria

May 25, 2000

First Posted (Estimate)

May 26, 2000

Study Record Updates

Last Update Posted (Estimate)

March 16, 2016

Last Update Submitted That Met QC Criteria

March 15, 2016

Last Verified

February 1, 2005

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5014
  • R01HL058755 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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