- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02062216
Role of the Inflammatory Receptors in the Pathogenesis of Atherosclerosis (Receptors)
Aperçu de l'étude
Statut
Les conditions
Description détaillée
Atherosclerosis is a chronic inflammatory disease characterized by lipid deposition and macrophages/foam cell accumulation beneath the arterial intima. Immune competent cells are abundant in atherosclerotic lesions, where they produce mainly proinflammatory cytokines. Macrophages play a central role in each stage of the pathogenesis of atherosclerosis. At the beginning, the so-called foam cells contribute to the formation of early lesions; in mature plaques, macrophages constitute 50% of the cells in the lesion; finally, they are involved in the mechanisms leading to plaque rupture.
The primary objective of this study is to assess whether the inflammatory receptors play a role in the pathogenesis of atherosclerosis.
Type d'étude
Inscription (Anticipé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Francesco Pelliccia, MD
- Numéro de téléphone: 123 +39064994
- E-mail: f.pelliccia@mclink.it
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
Study Population 1 Patients with ST-elevation myocardial infarction (STEMI) with angiographic evidence of massive thrombosis in the culprit artery undergoing primary percutaneous coronary intervention (PCI)
Study Population 2 Patients with coronary artery disease in stable conditions scheduled to undergo elective percutaneous coronary intervention and patients with Class I indication to elective percutaneous coronary intervention
La description
Study Population 1 Patients with ST-elevation myocardial infarction (STEMI) with angiographic evidence of massive thrombosis in the culprit artery undergoing primary percutaneous coronary intervention (PCI)
Criteria
Inclusion Criteria:
- ST-elevation myocardial infarction
- Angiographic evidence of massive thrombosis in the culprit artery
- Indication to primary percutaneous coronary intervention (PCI)
- Able to understand and willing to sign the informed CF
Exclusion Criteria:
• Women of child bearing potential patients must demonstrate a negative pregnancy test performed within 24 hours before CT
Study Population 2 Patients with coronary artery disease in stable conditions scheduled to undergo elective percutaneous coronary intervention and patients with
Criteria
Inclusion Criteria:
- A de novo native coronary artery lesions (reference vessel diameter:2.5-3.75 mm)
- Class I indication to elective percutaneous coronary intervention
- Stable conditions and no recent acute coronary syndromes
- Normal baseline values of markers of myocardial damage (creatine kinase, creatine kinase-MB, myoglobin, and troponin I)
- Able to understand and willing to sign the informed CF
Exclusion Criteria:
• Women of child bearing potential patients must demonstrate a negative pregnancy test performed within 24 hours before CT
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
---|
STEMI
Patients with ST-elevation myocardial infarction (STEMI) with angiographic evidence of massive thrombosis in the culprit artery undergoing primary percutaneous coronary intervention (PCI)
|
STABLE ANGINA
Patients with coronary artery disease in stable conditions scheduled to undergo elective percutaneous coronary intervention and patients with Class I indication to elective percutaneous coronary intervention
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Level of the inflammatory receptors
Délai: Baseline
|
Determination of plasmatic level of the inflammatory receptors
|
Baseline
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
C-reactive protein (CPR)
Délai: Up to 24 hours after PCI
|
Changes 24 hours after PCI in C-reactive protein (CPR)
|
Up to 24 hours after PCI
|
Fibrinogen
Délai: Up to 24 hours after PCI
|
Changes 24 hours after PCI in fibrinogen
|
Up to 24 hours after PCI
|
Plasminogen activator inhibitor (PAI-1)
Délai: Up to 24 hours after PCI
|
Changes 24 hours after PCI in Plasminogen activator inhibitor (PAI-1)
|
Up to 24 hours after PCI
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
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
Autres numéros d'identification d'étude
- 81/2014/D
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