- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00005547
Infection and Cardiovascular Disease
Aperçu de l'étude
Statut
Description détaillée
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.
Type d'étude
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Plan d'étude
Comment l'étude est-elle conçue ?
Collaborateurs et enquêteurs
Les enquêteurs
- Michael Davidson, Medlantic Research Institute
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Ischémie
- Processus pathologiques
- Nécrose
- Ischémie myocardique
- Maladies vasculaires
- Troubles cérébrovasculaires
- Maladies du cerveau
- Maladies du système nerveux central
- Maladies du système nerveux
- Maladies virales
- Maladies sexuellement transmissibles
- Artériosclérose
- Maladies artérielles occlusives
- Attributs de la maladie
- Infections par le virus de l'ADN
- Infections bactériennes à Gram négatif
- Infections bactériennes
- Infections bactériennes et mycoses
- Infections à Herpesviridae
- Infarctus
- Infections à Chlamydiacées
- Maladies sexuellement transmissibles, bactériennes
- Infarctus du myocarde
- Maladies cardiaques
- Accident vasculaire cérébral
- Maladie coronarienne
- Maladies cardiovasculaires
- Infections
- Maladies transmissibles
- Athérosclérose
- Infections à Helicobacter
- Infections à cytomégalovirus
- Infections à Chlamydia
Autres numéros d'identification d'étude
- 5091
- R01HL062233 (Subvention/contrat des NIH des États-Unis)
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