Rationale and design of the Cyclosporine to ImpRove Clinical oUtcome in ST-elevation myocardial infarction patients the CIRCUS trialReportar como inadecuado

Rationale and design of the Cyclosporine to ImpRove Clinical oUtcome in ST-elevation myocardial infarction patients the CIRCUS trial - Descarga este documento en PDF. Documentación en PDF para descargar gratis. Disponible también para leer online.

* Corresponding author 1 Hôpital Cardiovasculaire Louis Pradel 2 CHRU Montpellier - Centre Hospitalier Régional Universitaire Montpellier 3 LBP - Laboratoire de Biophotonique et Pharmacologie - UMR 7213 4 Les Hôpitaux Universitaires de Strasbourg HUS 5 CHRU Nîmes - Centre Hospitalier Régional Universitaire Nîmes 6 Cellules Dendritiques, Immunomodulation et Greffes 7 Hôpital Guillaume et René Laennec 8 Service de cardiologie Toulouse 9 Centre Hospitalier de Pau 10 Department of Cardiology 11 Cardio - BORDEAUX - Department of Cardiology 12 Radiopharmaceutiques biocliniques 13 Centre Hôspitalier Henri Duffaut 14 Hôpital Saint Joseph Saint Luc 15 Centre Hospitalier du Pays d-Aix 16 CHU - CHU Gabriel Montpied 17 Service de cardiologie 18 Clinique Lafourcade Bayonne 19 Hôpital Bichat - Claude Bernard 20 LNC - Lipides - Nutrition - Cancer U866 21 CHU Dijon 22 Centre Hospitalier Général 23 Centre Hospitalier Compiègne-Noyon 24 Hospital St-Jan Bruges 25 Service de Cardiologie 26 PMRM - Laboratoire de Protection et Remodelage du Myocarde 27 CHU Nancy - Centre hospitalier de Nancy 28 CH MULHOUSE 29 Service de Cardiologie 30 CHU Henri Mondor 31 Polyclinique Les Fleurs 32 ORPHY EA 4324 - Optimisation des régulations physiologiques 33 IGF - Institut de Génomique Fonctionnelle 34 Clinique Esquirol St Hilaire 35 Hôpital Privé Jacques Cartier Massy 36 Clinique du Diaconat 37 Grand Hopital de Charleroi 38 Centre Hospitalier Privé Claude Galien 39 LTSI - Laboratoire Traitement du Signal et de l-Image 40 Polyclinique de l-Ormeau 41 Pôle Cardiologie Interventionnelle - Coro-scanner - IRM Cardiaque 42 CHU Caen 43 Clinique de la Sauvegarde Lyon 44 Clinique du Tonkin 45 CHRU Lille - Centre Hospitalier Régional Universitaire Lille 46 Lund University Lund 47 Scandinavian Development Services AB 48 Universiteit Antwerpen Antwerpen 49 Hospital Vall d-Hebron 50 Cardioprotection

Abstract : BACKGROUND: Both acute myocardial ischemia and reperfusion contribute to cardiomyocyte death in ST-elevation myocardial infarction STEMI. The final infarct size is the principal determinant of subsequent clinical outcome in STEMI patients. In a proof-of-concept phase II trial, the administration of cyclosporine prior to primary percutaneous coronary intervention PPCI has been associated with a reduction of infarct size in STEMI patients. METHODS: CIRCUS is an international, prospective, multicenter, randomized, double-blinded, placebo-controlled trial. The study is designed to compare the efficacy and safety of cyclosporine versus placebo, in addition to revascularization by PPCI, in patients presenting with acute anterior myocardial infarction within 12 hours of symptoms onset and initial TIMI flow ≤1 in the culprit left anterior descending coronary artery. Patients are randomized in a 1:1 fashion to 2.5 mg-kg intravenous infusion of cyclosporine or matching placebo performed in the minutes preceding PCI. The primary efficacy end point of CIRCUS is a composite of 1-year all-cause mortality, rehospitalization for heart failure or heart failure worsening during initial hospitalization, and left ventricular adverse remodeling as determined by sequential transthoracic echochardiography. Secondary outcomes will be tested using a hierarchical sequence of left ventricular LV ejection fraction and absolute measurements of LV volumes. The composite of death and rehospitalization for heart failure or heart failure worsening during initial hospitalization will be further assessed at three years after the initial infarction. RESULTS: Recruitment lasted from April 2011 to February 2014. The CIRCUS trial has recruited 975 patients with acute anterior myocardial infarction. The 12-months results are expected to be available in 2015. CONCLUSIONS: The CIRCUS trial is testing the hypothesis that cyclosporine in addition to early revascularization with PPCI compared to placebo in patients with acute anterior myocardial infarction reduces the incidence of death, heart failure and adverse LV remodeling at one-year follow-up

Autor: Nathan Mewton - Thien T. Cung - Olivier Morel - Guillaume Cayla - Eric Bonnefoy-Cudraz - Gilles Rioufol - Denis Angoulvant - Patr

Fuente: https://hal.archives-ouvertes.fr/


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