title: A single-center prospective randomized controlled trial evaluating the safety and efficacy of IntraCoronary Erythropoietin delivery BEfore Reperfusion: gauging infarct size in patients with acute ST-segment elevation myocardial infarction. Study design and rationale of the 'ICEBERG Trial'.
abstract: BACKGROUND
  Erythropoietin (EPO) protected the myocardium from ischemia and reperfusion injury in preclinical studies. However, whether EPO can reduce myocardial injury in patients with acute myocardial infarction (MI) is controversial. The inconsistent results of previous studies have been attributed to differences in the doses, timing, and routes of administration of EPO. In this study, we will evaluate intracoronary treatment with a long-acting EPO analog, darbepoetin-α, administered immediately before reperfusion in patients with acute anterior ST-segment elevation MI.
  
  
  METHODS
  This trial will be a single-center, prospective, randomized, two-arm, controlled trial with blind evaluation of the endpoints. At the time of the primary percutaneous coronary intervention, 80 patients will randomly receive one of the following treatments immediately before the first ballooning: intracoronary darbepoetin-α (ARANESP®; Jeil-Kirin Pharm., Korea) 300μg (n=40) or saline (n=40), administered via the over-the-wire balloon system. The objectives of this study are to evaluate the safety and efficacy of intracoronary darbepoetin-α therapy.
  
  
  CONCLUSIONS
  This is the first study to evaluate the safety and efficacy of intracoronary darbepoetin-α treatment in patients with acute MI.
authors.affiliation: Department of Internal Medicine, Seoul National University College of Medicine, Cardiovascular Center, Seoul National University Bundang Hospital, Seongnam, South Korea.
authors.forename: Jung-Won
authors.initials: JW
authors.lastname: Suh
authors.forename: Yeonyee E
authors.initials: YE
authors.lastname: Yoon
authors.forename: Il-Young
authors.initials: IY
authors.lastname: Oh
authors.forename: Chang-Hwan
authors.initials: CH
authors.lastname: Yoon
authors.forename: Young-Seok
authors.initials: YS
authors.lastname: Cho
authors.forename: Tae-Jin
authors.initials: TJ
authors.lastname: Youn
authors.forename: In-Ho
authors.initials: IH
authors.lastname: Chae
authors.forename: Dong-Ju
authors.initials: DJ
authors.lastname: Choi
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D003331:Coronary Vessels; D000068256:Darbepoetin alfa; D004562:Electrocardiography; D004921:Erythropoietin / Q000008:administration & dosage* / Q000031:analogs & derivatives; D006397:Hematinics / Q000008:administration & dosage; D006801:Humans; D008875:Middle Aged; D009203:Myocardial Infarction / Q000188:drug therapy* / Q000473:pathology / Q000503:physiopathology; D015425:Myocardial Reperfusion; D011446:Prospective Studies; D012107:Research Design
chemical_list: D006397:Hematinics; D004921:Erythropoietin; D000068256:Darbepoetin alfa