A randomised, double-blind, placebo-controlled trial assessing the safety and efficacy of intracoronary NITRITE infusion during Acute Myocardial Infarction

INTERVENTION: Sodium Chloride, Placebo 10mls Intra‐coronary at time of PPCI; Sodium Nitrite, Study IMP 10mls 1.8% intra‐coronary during PPCI The experimental intervention is a bolus of sodium nitrite solution (1.8 micromol in 10 ml (pre‐diluted in 0.9% sodium chloride in a syringe) which will be delivered over 30 seconds via intracoronary injection initiated during the re‐establishment of antegrade epicardial flow with PPCI. The control intervention is a bolus of 0.9% sodium chloride solution (prepared with an identical appearance to the sodium nitrite). CONDITION: Topic: Cardiovascular; Subtopic: Cardiovascular (all Subtopics); Disease: Atherothrombosis ; Circulatory System ; Acute myocardial infarction PRIMARY OUTCOME: Creatine Kinase AUC first 48 hours after PPCI SECONDARY OUTCOME: 1. Infarct size on CMR; Timepoint(s): 48 hours and 6 months; 2. Myocardial salvage index (MSI) on CMR; Timepoint(s): 48 hours; 3. Troponin T AUC; Timepoint(s): 1st 48 hours after PPCI INCLUSION CRITERIA: 1. Patients aged at least 18 years, upper age limit 80 years, male and female 2. Acute ST‐elevation myocardial infarction with ECG showing at least 2 mm of ST segment elevation in 2 or more limb leads or 1mm in 2 or more contiguous chest leads, or new left bundle branch block 3. Haemodynamically stable 4. Estimated symptom to balloon or aspiration time < 6 hours 5. A signed and dated written informed consent prior to admission to the study 6. Angiographicallly 6.1. Primary Percutaneous Coronary Intervention (PPCI) indicated for revascularisation 6.2. Single epicardial artery to be treated 6.3. Expected ability to use the over the wire balloon for delivery of nitrite