NIAMI - Nitrites in Acute Myocardial Infarction

• Research type

  Research Study

• Full title

  Does nitrite reduce ischaemia-reperfusion injury in patients with acute ST segment elevation myocardial infarction?

• IRAS ID

  63380

• Contact name

  Michael Frenneaux

• Sponsor organisation

  Norfolk and Norwich NHS Foundation Trust

• Eudract number

  2010-023571-26

• Research summary

  There are estimated to be 125,000 acute myocardial infarctions (heart attacks) in the UK every year. Although substantial progress has been made in reducing the infarct size by prompt opening of the infarct related artery (with thrombolytic therapy or percutaneous coronary intervention (PCI)), effective therapy to further reduce the infarct size would substantially reduce the risk of the patient subsequently developing heart failure.There is a growing body of evidence from studies in animals that the use of nitrites may help in reducing the infarct size, although this has not been tested in man.In this phase 2 study, we propose to investigate the effect of sodium nitrite injection on infarct size. Eligible patients will be males aged 18 and over and females aged 55 and over, presenting within 12 hours of the onset of chest pain, who are suitable for treatment with PCI. Those who give verbal agreement to take part will receive a 5 minute injection of sodium nitrite (or placebo) immediately prior to the blocked artery being opened with PCI. The primary outcome is final infarct size which will be assessed by MRI (medical resonance imaging) scan 10-14 days after the injection of sodium nitrite or placebo. Secondary outcomes are left ventricular ejection fraction (how well the heart is pumping blood) measured at 10-14 days and 6 months after the injection of sodium nitrite or placebo using MRI and levels of plasma creatine kinase and Troponin I (both of which measure the amount of heart muscle damage) over the 72 hours after injection of sodium nitrite or placebo.

• REC name

  Scotland A REC

• REC reference

  10/MRE00/83

• Date of REC Opinion

  2 Mar 2011

• REC opinion

  Further Information Favourable Opinion