title: Randomized evaluation of intracoronary nitroprusside vs. adenosine after thrombus aspiration during primary percutaneous coronary intervention for the prevention of no-reflow in acute myocardial infarction: the REOPEN-AMI study protocol.
abstract: BACKGROUND
  Thrombus aspiration improves microvascular obstruction in patients with acute myocardial infarction treated by percutaneous coronary intervention. However, drugs such as nitroprusside and adenosine have not yet been tested as adjuncts to thrombus aspiration. Therefore, we designed a placebo-controlled, randomized, open-label, blind-examination, multicenter trial assessing the effects of intracoronary nitroprusside or adenosine on microvascular obstruction in patients undergoing primary or rescue percutaneous coronary intervention and thrombus aspiration.
  
  
  RESULTS
  Six hospitals in Italy participate in the REOPEN-AMI study. Two hundred and forty consecutive patients with acute myocardial infarction undergoing primary or rescue percutaneous coronary intervention and thrombus aspiration are randomly allocated 1: 1: 1 to receive either intracoronary nitroprusside, adenosine or placebo. The primary end-point is the incidence of ST resolution greater than 70% on surface ECG at 90 min after the procedure. Secondary end-points are: incidence of angiographic no-reflow (thrombolysis in myocardial infarction flow < or =2 or 3 with a myocardial blush grade <2); changes of left ventricular volumes at follow-up (at bidimensional echocardiography); rate of major adverse cardiac events (cardiac death, myocardial infarction, target lesion revascularization and heart failure requiring hospitalization).
  
  
  CONCLUSIONS
  REOPEN-AMI will provide important data on the efficacy and safety of intracoronary nitroprusside and adenosine as an adjunctive treatment to percutaneous coronary intervention after thrombus aspiration for patients with acute myocardial infarction.
authors.affiliation: Institute of Cardiology, Catholic University of the Sacred Heart, Italy. gniccoli73@hotmail.it
authors.forename: Giampaolo
authors.initials: G
authors.lastname: Niccoli
authors.forename: Domenico
authors.initials: D
authors.lastname: D'amario
authors.forename: Cristina
authors.initials: C
authors.lastname: Spaziani
authors.forename: Nicola
authors.initials: N
authors.lastname: Cosentino
authors.forename: Marcello
authors.initials: M
authors.lastname: Marino
authors.forename: Stefano
authors.initials: S
authors.lastname: Rigattieri
authors.forename: Paolo Lo
authors.initials: PL
authors.lastname: Schiavo
authors.forename: Maria Rosaria
authors.initials: MR
authors.lastname: De Vita
authors.forename: Fabio
authors.initials: F
authors.lastname: Tarantino
authors.forename: Antonio
authors.initials: A
authors.lastname: Bartorelli
authors.forename: Franco
authors.initials: F
authors.lastname: Fabbiocchi
authors.forename: Francesco
authors.initials: F
authors.lastname: Prati
authors.forename: Fabrizio
authors.initials: F
authors.lastname: Imola
authors.forename: Marco
authors.initials: M
authors.lastname: Valgimigli
authors.forename: Roberto
authors.initials: R
authors.lastname: Ferrari
authors.forename: Filippo
authors.initials: F
authors.lastname: Crea
mesh_terms: D000241:Adenosine / Q000008:administration & dosage*; D015906:Angioplasty, Balloon, Coronary; D002985:Clinical Protocols; D003131:Combined Modality Therapy; D017023:Coronary Angiography; D004452:Echocardiography; D004562:Electrocardiography; D006801:Humans; D007558:Italy; D009203:Myocardial Infarction / Q000150:complications / Q000175:diagnosis / Q000628:therapy*; D009599:Nitroprusside / Q000008:administration & dosage*; D054318:No-Reflow Phenomenon / Q000175:diagnosis / Q000209:etiology / Q000517:prevention & control*; D012107:Research Design; D013396:Suction; D017131:Thrombectomy / Q000379:methods*; D016896:Treatment Outcome; D014665:Vasodilator Agents / Q000008:administration & dosage*
chemical_list: D014665:Vasodilator Agents; D009599:Nitroprusside; D000241:Adenosine