title: Rationale and design of a double-blind, multicenter, randomized, placebo-controlled clinical trial of early administration of intravenous β-blockers in patients with ST-elevation myocardial infarction before primary percutaneous coronary intervention: EARLY β-blocker administration before primary PCI in patients with ST-elevation myocardial infarction trial.
abstract: BACKGROUND
  β-Blockers have a class 1a recommendation in the treatment of patients with ST-elevation myocardial infarctions (STEMIs), as they are associated with a reduced mortality, recurrent myocardial infarction, life-threatening arrhythmias, and with prevention of unfavorable left ventricular remodeling. Whether early administration before primary percutaneous coronary intervention (PCI) of intravenous β-blockers reduces the infarct size in the current era is unknown.
  
  
  OBJECTIVE
  We postulate that the early administration of β-blockers will reduce the myocardial infarcted area as assessed by magnetic resonance imaging (MRI) at 30 days.
  
  
  METHODS
  In a multinational, multicenter, double-blind, placebo-controlled, randomized trial, patients with symptoms and signs of STEMI and transferred to a hospital for primary PCI will be randomized in a 1:1 fashion to intravenous metoprolol (5 mg twice daily) administration or placebo. Before admission, study treatment will be started as soon as possible after the diagnosis of STEMI. After admission, primary PCI will be performed as per standard of care. After primary PCI, medical treatment will occur as per current guidelines in all patients, including the use of oral β-blockers. The primary end point is the myocardial infarct size as assessed by MRI at 30 days. Based on a superiority design and assuming an 18% relative infarct size reduction (from 28% to 23.5%), 408 patients are required to be enrolled, accounting for 20% drop-out (α = .05 and power = 80%).
  
  
  CONCLUSIONS
  The EARLY-BAMI trial is a multinational, multicenter, double-blind, placebo-controlled, randomized clinical trial that will investigate the impact of intravenous metoprolol administration before primary PCI for STEMI on myocardial infarct size as measured with MRI at 30 days.
authors.affiliation: Isala Klinieken, Department of Cardiology, Zwolle, The Netherlands. Electronic address: v.r.c.derks@isala.nl.
authors.forename: Vincent
authors.initials: V
authors.lastname: Roolvink
authors.affiliation: Isala Klinieken, Department of Cardiology, Zwolle, The Netherlands.
authors.forename: Saman
authors.initials: S
authors.lastname: Rasoul
authors.affiliation: Isala Klinieken, Department of Cardiology, Zwolle, The Netherlands.
authors.forename: Jan Paul
authors.initials: JP
authors.lastname: Ottervanger
authors.affiliation: Isala Klinieken, Department of Cardiology, Zwolle, The Netherlands.
authors.forename: Jan-Henk E
authors.initials: JH
authors.lastname: Dambrink
authors.affiliation: University of Groningen, University Medical Center Groningen, Department of Cardiology, Groningen, The Netherlands.
authors.forename: Erik
authors.initials: E
authors.lastname: Lipsic
authors.affiliation: University of Groningen, University Medical Center Groningen, Department of Critical Care, Groningen, The Netherlands.
authors.forename: Iwan C C
authors.initials: IC
authors.lastname: van der Horst
authors.affiliation: Meander Medisch Centrum, Department of Cardiology, Amersfoort, The Netherlands.
authors.forename: Bart
authors.initials: B
authors.lastname: de Smet
authors.affiliation: Isala Klinieken, Department of Cardiology, Zwolle, The Netherlands.
authors.forename: Elvin
authors.initials: E
authors.lastname: Kedhi
authors.affiliation: Isala Klinieken, Department of Cardiology, Zwolle, The Netherlands.
authors.forename: A T
authors.initials: AT
authors.lastname: Marcel Gosselink
authors.affiliation: Academic Medical Center, Department of Cardiology, Amersfoort, The Netherlands.
authors.forename: Jan J
authors.initials: JJ
authors.lastname: Piek
authors.affiliation: Servicio de Urgencia Medica de Madrid (SUMMA 112), Madrid, Spain.
authors.forename: Vicente
authors.initials: V
authors.lastname: Sanchez-Brunete
authors.affiliation: Centro Nacional de Investigaciones Cardiovasculares (CNIC), Madrid, Spain; Cardiovascular Institute, Hospital Clinico San Carlos, Madrid, Spain.
authors.forename: Borja
authors.initials: B
authors.lastname: Ibanez
authors.affiliation: Centro Nacional de Investigaciones Cardiovasculares (CNIC), Madrid, Spain; Cardiovascular Institute, Hospital Clinico San Carlos, Madrid, Spain; The Zena and Michael A Wiener Cardiovascular Institute, Mount Sinai School of Medicine, New York, NY.
authors.forename: Valentin
authors.initials: V
authors.lastname: Fuster
authors.affiliation: Isala Klinieken, Department of Cardiology, Zwolle, The Netherlands.
authors.forename: Arnoud W J
authors.initials: AW
authors.lastname: Van't Hof
mesh_terms: D061605:Administration, Intravenous; D000319:Adrenergic beta-Antagonists / Q000008:administration & dosage*; D003131:Combined Modality Therapy; D004311:Double-Blind Method; D061345:Early Medical Intervention; D006801:Humans; D008279:Magnetic Resonance Imaging; D008790:Metoprolol / Q000008:administration & dosage*; D009203:Myocardial Infarction / Q000473:pathology / Q000628:therapy*; D009206:Myocardium / Q000473:pathology*; D009336:Necrosis; D062645:Percutaneous Coronary Intervention / Q000379:methods*; D013997:Time Factors; D016896:Treatment Outcome; D020257:Ventricular Remodeling
chemical_list: D000319:Adrenergic beta-Antagonists; D008790:Metoprolol