title: Randomized phase 2 trial of intracoronary nitrite during acute myocardial infarction.
abstract: BACKGROUND
  Preclinical evidence demonstrates that inorganic nitrite, after its in situ conversion to nitric oxide, attenuates consequent myocardial reperfusion injury.
  
  
  OBJECTIVE
  We investigated whether intracoronary injection of nitrite during primary percutaneous coronary intervention might improve infarct size in ST-elevated myocardial infarction.
  
  
  RESULTS
  Patients undergoing primary percutaneous coronary intervention (n=80) were randomized to receive intracoronary (10 mL) sodium nitrite (1.8 μmol) or NaCl (placebo) before balloon inflation. The primary end point was infarct size assessed by measuring creatine kinase release. Secondary outcomes included infarct size assessed by troponin T release and by cardiac MRI on day 2. Baseline characteristics were similar between the groups. No evidence of differences in creatine kinase release (P=0.92), troponin T (P=0.85), or cardiac MRI-assessed infarct size (P=0.254) were evident. In contrast, there was an improvement [corrected] in myocardial salvage index (P=0.05) and reduction in [corrected] major adverse cardiac event at 1 year (2.6% versus 15.8%; P=0.04) in the nitrite group. In a 66-patient subgroup with thrombolysis in myocardial infarction ≤1 flow, there was reduced serum creatine kinase (P=0.030) and a 19% reduction in cardiac MRI-determined infarct size (P=0.034) with nitrite. No adverse effects of nitrite were detected.
  
  
  CONCLUSIONS
  In this phase II study, intracoronary nitrite infusion did not alter infarct size, although a trend to improved myocardial salvage index and a significant reduction in major adverse cardiac event was evident. In a subgroup of patients with thrombolysis in myocardial infarction flow ≤1, nitrite reduced infarct size and major adverse cardiac event and improved myocardial salvage index, indicating that a phase III clinical trial assessing intracoronary nitrite administration as an adjunct to percutaneous coronary intervention in ST-elevated myocardial infarction patients is warranted.
  
  
  BACKGROUND
  http://www.clinicaltrials.gov. Unique identifier: NCT01584453.
authors.affiliation: From the Barts National Institute for Health Research Cardiovascular Biomedical Research Unit, William Harvey Research Institute, Barts and The London Medical School (D.A.J., S.V., K.S.R., S.A., S.v.E., A.J.W., A.M., A.A.); and Department of Cardiology, London Chest Hospital, Barts Health NHS Trust (D.A.J., C.P., S.V., M.A., M.A.W., A.M.), and MRC Clinical Trials Unit at UCL (M.K.P.), University College London, Aviation House, Kingsway, London, UK.
authors.forename: Daniel A
authors.initials: DA
authors.lastname: Jones
authors.affiliation: From the Barts National Institute for Health Research Cardiovascular Biomedical Research Unit, William Harvey Research Institute, Barts and The London Medical School (D.A.J., S.V., K.S.R., S.A., S.v.E., A.J.W., A.M., A.A.); and Department of Cardiology, London Chest Hospital, Barts Health NHS Trust (D.A.J., C.P., S.V., M.A., M.A.W., A.M.), and MRC Clinical Trials Unit at UCL (M.K.P.), University College London, Aviation House, Kingsway, London, UK.
authors.forename: Cyril
authors.initials: C
authors.lastname: Pellaton
authors.affiliation: From the Barts National Institute for Health Research Cardiovascular Biomedical Research Unit, William Harvey Research Institute, Barts and The London Medical School (D.A.J., S.V., K.S.R., S.A., S.v.E., A.J.W., A.M., A.A.); and Department of Cardiology, London Chest Hospital, Barts Health NHS Trust (D.A.J., C.P., S.V., M.A., M.A.W., A.M.), and MRC Clinical Trials Unit at UCL (M.K.P.), University College London, Aviation House, Kingsway, London, UK.
authors.forename: Shanti
authors.initials: S
authors.lastname: Velmurugan
authors.affiliation: From the Barts National Institute for Health Research Cardiovascular Biomedical Research Unit, William Harvey Research Institute, Barts and The London Medical School (D.A.J., S.V., K.S.R., S.A., S.v.E., A.J.W., A.M., A.A.); and Department of Cardiology, London Chest Hospital, Barts Health NHS Trust (D.A.J., C.P., S.V., M.A., M.A.W., A.M.), and MRC Clinical Trials Unit at UCL (M.K.P.), University College London, Aviation House, Kingsway, London, UK.
authors.forename: Krishnaraj Sinha
authors.initials: KS
authors.lastname: Rathod
authors.affiliation: From the Barts National Institute for Health Research Cardiovascular Biomedical Research Unit, William Harvey Research Institute, Barts and The London Medical School (D.A.J., S.V., K.S.R., S.A., S.v.E., A.J.W., A.M., A.A.); and Department of Cardiology, London Chest Hospital, Barts Health NHS Trust (D.A.J., C.P., S.V., M.A., M.A.W., A.M.), and MRC Clinical Trials Unit at UCL (M.K.P.), University College London, Aviation House, Kingsway, London, UK.
authors.forename: Mervyn
authors.initials: M
authors.lastname: Andiapen
authors.affiliation: From the Barts National Institute for Health Research Cardiovascular Biomedical Research Unit, William Harvey Research Institute, Barts and The London Medical School (D.A.J., S.V., K.S.R., S.A., S.v.E., A.J.W., A.M., A.A.); and Department of Cardiology, London Chest Hospital, Barts Health NHS Trust (D.A.J., C.P., S.V., M.A., M.A.W., A.M.), and MRC Clinical Trials Unit at UCL (M.K.P.), University College London, Aviation House, Kingsway, London, UK.
authors.forename: Sotiris
authors.initials: S
authors.lastname: Antoniou
authors.affiliation: From the Barts National Institute for Health Research Cardiovascular Biomedical Research Unit, William Harvey Research Institute, Barts and The London Medical School (D.A.J., S.V., K.S.R., S.A., S.v.E., A.J.W., A.M., A.A.); and Department of Cardiology, London Chest Hospital, Barts Health NHS Trust (D.A.J., C.P., S.V., M.A., M.A.W., A.M.), and MRC Clinical Trials Unit at UCL (M.K.P.), University College London, Aviation House, Kingsway, London, UK.
authors.forename: Sven
authors.initials: S
authors.lastname: van Eijl
authors.affiliation: From the Barts National Institute for Health Research Cardiovascular Biomedical Research Unit, William Harvey Research Institute, Barts and The London Medical School (D.A.J., S.V., K.S.R., S.A., S.v.E., A.J.W., A.M., A.A.); and Department of Cardiology, London Chest Hospital, Barts Health NHS Trust (D.A.J., C.P., S.V., M.A., M.A.W., A.M.), and MRC Clinical Trials Unit at UCL (M.K.P.), University College London, Aviation House, Kingsway, London, UK.
authors.forename: Andrew J
authors.initials: AJ
authors.lastname: Webb
authors.affiliation: From the Barts National Institute for Health Research Cardiovascular Biomedical Research Unit, William Harvey Research Institute, Barts and The London Medical School (D.A.J., S.V., K.S.R., S.A., S.v.E., A.J.W., A.M., A.A.); and Department of Cardiology, London Chest Hospital, Barts Health NHS Trust (D.A.J., C.P., S.V., M.A., M.A.W., A.M.), and MRC Clinical Trials Unit at UCL (M.K.P.), University College London, Aviation House, Kingsway, London, UK.
authors.forename: Mark A
authors.initials: MA
authors.lastname: Westwood
authors.affiliation: From the Barts National Institute for Health Research Cardiovascular Biomedical Research Unit, William Harvey Research Institute, Barts and The London Medical School (D.A.J., S.V., K.S.R., S.A., S.v.E., A.J.W., A.M., A.A.); and Department of Cardiology, London Chest Hospital, Barts Health NHS Trust (D.A.J., C.P., S.V., M.A., M.A.W., A.M.), and MRC Clinical Trials Unit at UCL (M.K.P.), University College London, Aviation House, Kingsway, London, UK.
authors.forename: Mahesh K
authors.initials: MK
authors.lastname: Parmar
authors.affiliation: From the Barts National Institute for Health Research Cardiovascular Biomedical Research Unit, William Harvey Research Institute, Barts and The London Medical School (D.A.J., S.V., K.S.R., S.A., S.v.E., A.J.W., A.M., A.A.); and Department of Cardiology, London Chest Hospital, Barts Health NHS Trust (D.A.J., C.P., S.V., M.A., M.A.W., A.M.), and MRC Clinical Trials Unit at UCL (M.K.P.), University College London, Aviation House, Kingsway, London, UK.
authors.forename: Anthony
authors.initials: A
authors.lastname: Mathur
authors.affiliation: From the Barts National Institute for Health Research Cardiovascular Biomedical Research Unit, William Harvey Research Institute, Barts and The London Medical School (D.A.J., S.V., K.S.R., S.A., S.v.E., A.J.W., A.M., A.A.); and Department of Cardiology, London Chest Hospital, Barts Health NHS Trust (D.A.J., C.P., S.V., M.A., M.A.W., A.M.), and MRC Clinical Trials Unit at UCL (M.K.P.), University College London, Aviation House, Kingsway, London, UK. a.ahluwalia@qmul.ac.uk.
authors.forename: Amrita
authors.initials: A
authors.lastname: Ahluwalia
mesh_terms: D000368:Aged; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000188:drug therapy*; D012977:Sodium Nitrite / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D012977:Sodium Nitrite
keywords: acute myocardial infarction; nitric oxide; percutaneous coronary intervention