Rationale and design of the 'F.I.R.E.' study. A multicenter, double-blind, randomized, placebo-controlled study to measure the effect of FX06 (a fibrin-derived peptide Bbeta(15-42)) on ischemia-reperfusion injury in patients with acute myocardial infarction undergoing primary percutaneous coronary intervention.

Détails

ID Serval
serval:BIB_F784BDF5F29B
Type
Article: article d'un périodique ou d'un magazine.
Collection
Publications
Titre
Rationale and design of the 'F.I.R.E.' study. A multicenter, double-blind, randomized, placebo-controlled study to measure the effect of FX06 (a fibrin-derived peptide Bbeta(15-42)) on ischemia-reperfusion injury in patients with acute myocardial infarction undergoing primary percutaneous coronary intervention.
Périodique
Cardiology
Auteur(s)
Atar D., Huber K., Rupprecht H.J., Kopecky S.L., Schwitter J., Theek C., Brandl K., Henning R., Geudelin B.
ISSN
1421-9751 (Electronic)
ISSN-L
0008-6312
Statut éditorial
Publié
Date de publication
2007
Volume
108
Numéro
2
Pages
117-123
Langue
anglais
Notes
Publication types: Clinical Trial, Phase II ; Journal Article ; Multicenter Study ; Randomized Controlled Trial
Résumé
Immediate reopening of acutely occluded coronary arteries via primary percutaneous coronary intervention (PCI) is the treatment of choice to salvage the ischemic myocardium in the setting of ST-segment elevation myocardial infarction (STEMI). However, the sudden re-initiation of blood flow achieved with PCI can lead to a local acute inflammatory response with further endothelial and myocardial damage. This phenomenon, described as 'reperfusion injury', has been recognized for several decades, yet no pharmacologic intervention has so far succeeded in reducing myocardial damage linked to reperfusion. FX06 is a naturally occurring peptide derived from the neo-N-terminus of fibrin (Bbeta(15-42)). It prevents leukocyte migration through the gap junctions of endothelial cells. Experimental studies have shown that FX06 inhibits the binding of the proinflammatory fibrin E1 fragment to VE-cadherin expressed in the adherence junction. It represents a novel approach to reducing local and systemic inflammation, including myocardial reperfusion injury, in the adherens junction. The present multicenter, double-blind, randomized, placebo-controlled study is designed to test the hypothesis that FX06 injection during and immediately after primary PCI can reduce infarct size in patients with STEMI. The primary outcome measure of efficacy in this study is the degree of myocardial salvage calculated as the difference between the perfusion defect before and after PCI, determined by myocardial perfusion scintigraphy during rest. Further, infarct size at the end of the index hospitalization, as well as at 4 months, will be measured by cardiac magnetic resonance imaging. The present position paper describes the rationale, design and the methods utilized in this trial.
Mots-clé
Angioplasty, Balloon, Coronary, Clinical Trials Data Monitoring Committees, Conflict of Interest, Double-Blind Method, Fibrin Fibrinogen Degradation Products/therapeutic use, Humans, Magnetic Resonance Imaging, Myocardial Infarction/drug therapy, Myocardial Infarction/pathology, Myocardial Reperfusion Injury/drug therapy, Myocardial Reperfusion Injury/prevention & control, Peptide Fragments/therapeutic use, Research Design, Statistics as Topic, Tomography, Emission-Computed, Single-Photon
Pubmed
Web of science
Création de la notice
07/09/2011 18:05
Dernière modification de la notice
20/08/2019 17:23
Données d'usage