- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01460082
Endothelial Dysfunction in Acute Exacerbations of Chronic Obstructive Pulmonary Disease (COPD) (EDAECOPD)
Endothelial Dysfunction and Systemic Inflammation in Patients With Acute Exacerbations of Chronic Obstructive Pulmonary Disease
Aperçu de l'étude
Statut
Description détaillée
Chronic obstructive pulmonary disease (COPD) is a chronic inflammatory disease of the lungs; however, there is cumulating data suggesting that the inflammatory reaction associated with COPD is not restricted to the lungs but has systemic effects. Patients with COPD have increased cardiovascular morbidity and mortality. The suspected link between increased cardiovascular mortality and systemic inflammation is endothelial dysfunction, which in turn is caused by impaired activity of NO. Endothelial dysfunction has been demonstrated in patients with COPD. Furthermore there is a close correlation between endothelial dysfunction in coronary and peripheral vessels, which allows assessing flow-mediated dilation (FMD) in the brachial artery via high resolution ultrasound as an early predictor of atherosclerosis. Moreover, systemic inflammatory markers correlate with endothelial dysfunction in patients with stable COPD.
Exacerbations of COPD are episodes of worsening symptoms characterized by increased airway and systemic inflammation. If systemic inflammation is a cause of endothelial dysfunction in COPD, endothelial function would be suspected to be further impaired during exacerbation and recover thereafter. The purpose of this study is to determine a possible association between the clinical entity of exacerbation, markers of systemic inflammation and endothelial dysfunction in patients with COPD.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Vienna, L'Autriche, 1140
- 1.Department of Respiratory and Critical Care Medicine and Ludwig Boltzmann Institute for COPD, Otto-Wagner Hospital
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- presence of COPD according to standard criteria
- acute exacerbation of COPD according to recommended international criteria
- over 40 years of age
- history of at least 10 py
Exclusion Criteria:
- pneumonia
- history or signs of congestive heart failure,
- acute myocardial infarction
- thoracotomy incl. resection of lungtissue
- interstitial lung disease
- acute or chronic renal failure
- active malignancy
- autoimmune disease
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: Cas uniquement
- Perspectives temporelles: Transversale
Cohortes et interventions
Groupe / Cohorte |
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Exacerbation
The study sample will consist of patients admitted to the hospital because of an acute exacerbation of COPD
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
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change of endothelial dysfunction (impaired vasomotor reactivity due to shaer stress) confirmed by non-invasive measurement of flow mediated dilation (FMD) 6-8 weeks after acute exacerbation of COPD
Délai: Baseline, Week 6-8
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Baseline, Week 6-8
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
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change of systemic inflammation 6-8 weeks after COPD-exacerbation confirmed by inflammatory markers such as interleukin-6 (IL-6), fibrinogen levels, and C-reactive protein (CRP) levels
Délai: baseline, week 6-8
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baseline, week 6-8
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Collaborateurs et enquêteurs
Les enquêteurs
- Chercheur principal: Georg C Funk, M.D., 1. Department of Respiratory and Critical Care Medicine and Ludwig Boltzmann Institute for COPD, Otto-Wagner Hospital, Vienna, Austria
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
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
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- EDAECOPD
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