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    Randomized phase 2 trial of intracoronary nitrite during acute myocardial infarction 
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    Randomized phase 2 trial of intracoronary nitrite during acute myocardial infarction

    Volume
    116
    Pagination
    437 - 447
    DOI
    10.1161/CIRCRESAHA.116.305082
    Journal
    Circulation Research
    Issue
    3
    ISSN
    0009-7330
    Metadata
    Show full item record
    Abstract
    © 2014 American Heart Association, Inc. Rationale: 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. Methods and 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 a reduction in myocardial salvage index (P=0.05) and 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.
    Authors
    Jones, DA; Pellaton, C; Velmurugan, S; Rathod, KS; Andiapen, M; Antoniou, S; Van Eijl, S; Webb, AJ; Westwood, MA; Parmar, MK
    URI
    http://qmro.qmul.ac.uk/xmlui/handle/123456789/7741
    Collections
    • Centre for Clinical Pharmacology [931]
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