title: Granulocyte-colony stimulating factor for large anterior ST-elevation myocardial infarction: rationale and design of the prospective randomized phase III STEM-AMI OUTCOME trial.
abstract: BACKGROUND
  Granulocyte-colony stimulating factor (G-CSF) has been clinically tested in ST-elevation myocardial infarction (STEMI) with mixed results. Our 3-year follow-up data from STEM-AMI trial documented a sustained benefit of G-CSF on adverse ventricular remodeling after large anterior STEMI, when administered early and at a high-dose in patients with left ventricular (LV) dysfunction. The Aim of the present trial is to establish whether G-CSF improves hard clinical long-term outcomes.
  
  
  METHODS
  The STEM-AMI OUTCOME is a prospective, multicenter, randomized, open-label, phase III trial. It will include 1,530 patients with anterior STEMI undergoing primary percutaneous coronary intervention 2 to 24 hours after symptoms onset and with LV ejection fraction ≤45% after successful reperfusion. Patients will be randomized 1:1 to G-CSF and/or standard treatment. The primary end point is a reduced occurrence of all-cause death, recurrence of myocardial infarction, or hospitalization due to heart failure in G-CSF-treated patients. Left ventricular remodeling will be assessed via cardiac ultrasound and a substudy with cardiac magnetic resonance will be carried out in 120 subjects. Accrual and follow-up periods will last 3 and 2 years, respectively.
  
  
  CONCLUSIONS
  The STEM-AMI OUTCOME study is designed to be a rigorous controlled phase III trial with adequate statistical power to conclusively assess efficacy of G-CSF treatment in STEMI.
authors.affiliation: Cardiology Unit and Intensive and Coronary Care Unit, San Gerardo Hospital, Monza, Italy. Electronic address: felice.achilli@gmail.com.
authors.forename: Felice
authors.initials: F
authors.lastname: Achilli
authors.affiliation: Cardiology Unit and Intensive and Coronary Care Unit, San Gerardo Hospital, Monza, Italy.
authors.forename: Cristina
authors.initials: C
authors.lastname: Malafronte
authors.affiliation: Cardiology Unit and Intensive and Coronary Care Unit, San Gerardo Hospital, Monza, Italy.
authors.forename: Francesca
authors.initials: F
authors.lastname: Cesana
authors.affiliation: Department of Cardiology, San Leopoldo Mandic Hospital, Merate, Italy.
authors.forename: Stefano
authors.initials: S
authors.lastname: Maggiolini
authors.affiliation: Department of Cardiology, Cardarelli Hospital, Napoli, Italy.
authors.forename: Ciro
authors.initials: C
authors.lastname: Mauro
authors.affiliation: Cardiology Unit and Intensive and Coronary Care Unit, Fondazione Policlinico San Matteo IRCCS, Pavia, Italy.
authors.forename: Gaetano M
authors.initials: GM
authors.lastname: De Ferrari
authors.affiliation: Department of Cardiology, Alessandro Manzoni Hospital, Lecco, Italy.
authors.forename: Laura
authors.initials: L
authors.lastname: Lenatti
authors.affiliation: Cardiology Department, Bolognini Hospital, Seriate, Italy.
authors.forename: Maurizio
authors.initials: M
authors.lastname: Tespili
authors.affiliation: Cardiology Unit, Misericordia Hospital, Grosseto, Italy.
authors.forename: Paola
authors.initials: P
authors.lastname: Pasqualini
authors.affiliation: Department of Cardiology, Bassini Hospital, Cinisello Balsamo, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Gentile
authors.affiliation: Laboratory of Vascular Pathology, Istituto Dermopatico dell'Immacolata IRCCS, Rome, Italy.
authors.forename: Maurizio C
authors.initials: MC
authors.lastname: Capogrossi
authors.affiliation: Research Center of the Italian Association of Hospital Cardiologists (ANMCO), Florence, Italy.
authors.forename: Aldo
authors.initials: A
authors.lastname: Maggioni
authors.affiliation: Per il Tuo Cuore Onlus Foundation, Florence, Italy.
authors.forename: Attilio
authors.initials: A
authors.lastname: Maseri
authors.affiliation: Department of Cardiovascular Imaging, Cardiac Magnetic Resonance Unit, Centro Cardiologico Monzino IRCCS, Milan, Italy.
authors.forename: Gianluca
authors.initials: G
authors.lastname: Pontone
authors.affiliation: Immunology and Functional Genomics Unit, Centro Cardiologico Monzino IRCCS, Milan, Italy.
authors.forename: Gualtiero I
authors.initials: GI
authors.lastname: Colombo
authors.affiliation: Vascular Biology and Regenerative Medicine Unit, Centro Cardiologico Monzino IRCCS, and Cardiovascular Section, Department of Clinical Sciences and Community Health, University of Milan, Milan, Italy.
authors.forename: Giulio
authors.initials: G
authors.lastname: Pompilio
mesh_terms: D000368:Aged; D017023:Coronary Angiography; D004562:Electrocardiography; D005260:Female; D005500:Follow-Up Studies; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage*; D006801:Humans; D007269:Injections, Intra-Arterial; D019028:Magnetic Resonance Imaging, Cine; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D062645:Percutaneous Coronary Intervention / Q000379:methods*; D011446:Prospective Studies; D013997:Time Factors; D016896:Treatment Outcome; D016277:Ventricular Function, Left; D020257:Ventricular Remodeling
chemical_list: D016179:Granulocyte Colony-Stimulating Factor