title: Intravenous sodium nitrite in acute ST-elevation myocardial infarction: a randomized controlled trial (NIAMI).
abstract: OBJECTIVE
  Despite prompt revascularization of acute myocardial infarction (AMI), substantial myocardial injury may occur, in part a consequence of ischaemia reperfusion injury (IRI). There has been considerable interest in therapies that may reduce IRI. In experimental models of AMI, sodium nitrite substantially reduces IRI. In this double-blind randomized placebo controlled parallel-group trial, we investigated the effects of sodium nitrite administered immediately prior to reperfusion in patients with acute ST-elevation myocardial infarction (STEMI).
  
  
  RESULTS
  A total of 229 patients presenting with acute STEMI were randomized to receive either an i.v. infusion of 70 μmol sodium nitrite (n = 118) or matching placebo (n = 111) over 5 min immediately before primary percutaneous intervention (PPCI). Patients underwent cardiac magnetic resonance imaging (CMR) at 6-8 days and at 6 months and serial blood sampling was performed over 72 h for the measurement of plasma creatine kinase (CK) and Troponin I. Myocardial infarct size (extent of late gadolinium enhancement at 6-8 days by CMR-the primary endpoint) did not differ between nitrite and placebo groups after adjustment for area at risk, diabetes status, and centre (effect size -0.7% 95% CI: -2.2%, +0.7%; P = 0.34). There were no significant differences in any of the secondary endpoints, including plasma troponin I and CK area under the curve, left ventricular volumes (LV), and ejection fraction (EF) measured at 6-8 days and at 6 months and final infarct size (FIS) measured at 6 months.
  
  
  CONCLUSIONS
  Sodium nitrite administered intravenously immediately prior to reperfusion in patients with acute STEMI does not reduce infarct size.
authors.affiliation: School of Medicine and Dentistry, University of Aberdeen, Aberdeen AB25 2ZD, UK.
authors.forename: Nishat
authors.initials: N
authors.lastname: Siddiqi
authors.affiliation: School of Medicine and Dentistry, University of Aberdeen, Aberdeen AB25 2ZD, UK.
authors.forename: Christopher
authors.initials: C
authors.lastname: Neil
authors.affiliation: School of Medicine and Dentistry, University of Aberdeen, Aberdeen AB25 2ZD, UK.
authors.forename: Margaret
authors.initials: M
authors.lastname: Bruce
authors.affiliation: School of Medicine and Dentistry, University of Aberdeen, Aberdeen AB25 2ZD, UK.
authors.forename: Graeme
authors.initials: G
authors.lastname: MacLennan
authors.affiliation: School of Medicine and Dentistry, University of Aberdeen, Aberdeen AB25 2ZD, UK.
authors.forename: Seonaidh
authors.initials: S
authors.lastname: Cotton
authors.affiliation: St George's University of London, London, UK.
authors.forename: Sofia
authors.initials: S
authors.lastname: Papadopoulou
authors.affiliation: University of Southampton, Southampton, UK.
authors.forename: Martin
authors.initials: M
authors.lastname: Feelisch
authors.affiliation: St George's Healthcare NHS Trust, London, UK.
authors.forename: Nicholas
authors.initials: N
authors.lastname: Bunce
authors.affiliation: St George's Healthcare NHS Trust, London, UK.
authors.forename: Pitt O
authors.initials: PO
authors.lastname: Lim
authors.affiliation: Brighton and Sussex University Hospitals, Sussex, UK.
authors.forename: David
authors.initials: D
authors.lastname: Hildick-Smith
authors.affiliation: The Queen Elizabeth Hospital, Adelaide, South Australia.
authors.forename: John
authors.initials: J
authors.lastname: Horowitz
authors.affiliation: University of Birmingham, Birmingham, UK.
authors.forename: Melanie
authors.initials: M
authors.lastname: Madhani
authors.affiliation: University of Edinburgh, Edinburgh, UK.
authors.forename: Nicholas
authors.initials: N
authors.lastname: Boon
authors.affiliation: School of Medicine and Dentistry, University of Aberdeen, Aberdeen AB25 2ZD, UK.
authors.forename: Dana
authors.initials: D
authors.lastname: Dawson
authors.affiliation: St George's University of London, London, UK.
authors.forename: Juan Carlos
authors.initials: JC
authors.lastname: Kaski
authors.affiliation: School of Medicine and Dentistry, University of Aberdeen, Aberdeen AB25 2ZD, UK m.p.frenneaux@abdn.ac.uk.
authors.forename: Michael
authors.initials: M
authors.lastname: Frenneaux
mesh_terms: D015415:Biomarkers / Q000378:metabolism; D002316:Cardiotonic Agents / Q000008:administration & dosage*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000188:drug therapy* / Q000473:pathology; D015425:Myocardial Reperfusion / Q000379:methods; D015428:Myocardial Reperfusion Injury / Q000473:pathology / Q000517:prevention & control; D062645:Percutaneous Coronary Intervention / Q000379:methods; D012977:Sodium Nitrite / Q000008:administration & dosage*; D016896:Treatment Outcome
chemical_list: D015415:Biomarkers; D002316:Cardiotonic Agents; D012977:Sodium Nitrite
keywords: Acute myocardial infarction; Cardioprotection; Ischaemia-reperfusion injury; Nitrite