Nitrites in Acute Myocardial Infarction — NIAMI  

Acute ST Elevation Myocardial Infarction Clinical Trial

Official title: Does Sodium Nitrite Administration Reduce Ischaemia-reperfusion Injury in Patients Presenting With Acute ST Segment Elevation Myocardial Infarction?

Status Completed

Clinical Trial Summary

The research question to be addressed is "Does a 2.5 - 5 minute systemic intravenous injection of sodium nitrite administered immediately before opening of the infarct related artery result in significant reduction of ischaemia reperfusion injury in patients with first acute ST elevation myocardial infarction (MI)?"

Clinical Trial Description

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 2/3 study, the investigators 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 percutaneous coronary intervention. Those who give verbal agreement to take part will receive a 2.5-5 minute injection of sodium nitrite (or placebo) immediately prior to the blocked artery being opened with percutaneous coronary intervention. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute ST Elevation Myocardial Infarction
• Infarction
• Myocardial Infarction

• NCT number: NCT01388504
• Study type: Interventional
• Source: University of Aberdeen
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: July 2011
• Completion date: January 2014