We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Infection and Cardiovascular Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00005547
Recruitment Status : Completed
First Posted : May 26, 2000
Last Update Posted : February 18, 2016
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease
Cardiovascular Diseases Coronary Disease Cerebrovascular Accident Heart Diseases Myocardial Infarction Infection Chlamydia Infections Cytomegalovirus Infections Helicobacter Infections Atherosclerosis

Detailed Description:

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.

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 Design

Study Type : Observational
Study Start Date : April 1999
Study Completion Date : June 2003

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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): NCT00005547


Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
OverallOfficial: Michael Davidson Medlantic Research Institute
More Information

Publications:
ClinicalTrials.gov Identifier: NCT00005547     History of Changes
Other Study ID Numbers: 5091
R01HL062233 ( U.S. NIH Grant/Contract )
First Posted: May 26, 2000    Key Record Dates
Last Update Posted: February 18, 2016
Last Verified: January 2005

Additional relevant MeSH terms:
Infection
Communicable Diseases
Infarction
Cardiovascular Diseases
Heart Diseases
Myocardial Infarction
Atherosclerosis
Coronary Disease
Coronary Artery Disease
Stroke
Cytomegalovirus Infections
Helicobacter Infections
Chlamydia Infections
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Gram-Negative Bacterial Infections
Bacterial Infections
Chlamydiaceae Infections