Introduction: Despite reperfusion therapy for acute myocardial infarction (AMI), heart failure remains a major sequel.Reperfusion leads to further damage, described as ischemiareperfusion-injury (IRI).This contributes up to 50% of the final infarct size.In pre-clinical models nitrite potently protects against IRI in the heart and other organs.Hypothesis: Intravenous (iv) sodium nitrite, administered immediately before opening of the infarctrelated artery, results in significant reduction of IRI in patients with acute ST elevation MI (STEMI).Methods: In this phase II, randomised, placebo-controlled, double-blind, multicentre trial, 220 patients with first acute STEMI and TIMI 0 or 1 flow were randomised in a double-blind fashion to 70micromol iv sodium nitrite or matching placebo over 5 minutes immediately preceding opening of the infarct-related artery.The primary end point was the difference in infarct size between sodium nitrite and placebo groups using cardiovascular magnetic resonance imaging (CMR) at 6-8 days following AMI, adjusted for area at risk (AAR), diabetes status and center.Secondary end points comprised (i) Infarct size (CMR) at six months; (ii) plasma CK and Troponin I measured over 72 hours after injection of the study medication; (iii) Infarct size corrected for AAR measured using T2 weighted CMR; (iv) left ventricular (LV) ejection fraction and LV end systolic volume index measured by CMR at 6-8 days and at six months.Results: Infarct size at 6-8 days by CMR did not differ between nitrite and placebo groups (effect size -0.7% 95%CI -2.2,+0.7;p=0.34).There were no significant differences in the predefined secondary end points.There was no treatment effect in non-diabetics, but in diabetics was -4.5% (95%CI -8.8,-0.2;p=0.041) but the interaction was not significant (p=0.067).Conclusion: Sodium nitrite administered iv immediately prior to reperfusion in patients with acute STEMI did not reduce infarct size.A potential benefit in diabetics warrants further study.Funding, Ethics,
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