Safety and Effectiveness of Intra-coronary Nitrite in Acute Myocardial Infarction
Condition: Myocardial Infarction; Reperfusion Injury; Myocardial Ischemia; Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases; Myocardial Infarction; Myocardial Ischemia; Reperfusion Injury; Infarction; Ischemia
Study type: Interventional
Phase: Phase 2

Summary: 
      Despite advances in the treatment of heart attacks the complications and death rates from
      failure of the heart to pump properly after treatment remain high. A heart attack occurs when
      one or more of the arteries that supply blood to the heart become blocked, causing the heart
      to be starved of oxygen and nutrients. This results in damage to the heart and so the the
      heart pumps less well. The main treatment for a heart attack is balloon treatment to open the
      blocked artery (called primary angioplasty). Whilst re-opening the artery is essential and
      allows blood to flow to the area of the heart starved of oxygen, this process also causes
      damage itself (called reperfusion injury) and increases the size of the heart attack further.
      Currently there are no treatments available that reduce this reperfusion injury. The
      investigators and others have shown that a substance called sodium nitrite reduces
      reperfusion injury in experimental models of a heart attack. The aim of this research is to
      perform a trial to investigate whether during a heart attack, an infusion of sodium nitrite
      into the damaged artery protects against reperfusion injury and reduces heart attack size in
      patients.
    

Detailed description: 
      Coronary heart disease is still the commonest cause of death in the UK (in the main as a
      consequence of acute myocardial infarction (AMI)). Presently, timely and effective
      reperfusion with primary percutaneous coronary intervention (PPCI) remains the most effective
      treatment strategy for limiting infarct size, preserving left ventricular ejection fraction
      (LVEF), and improving the clinical outcomes in such patients. However, substantial mortality
      and morbidity rates still persist with respect to longer term outcome. One of the main
      determinants of prognosis after AMI is the size of the infarct. Thus, identification of
      additional strategies that might decrease infarct size is desirable.

      Evidence from pre-clinical studies suggests that inorganic nitrite administration reduces
      infarct size in animal models of AMI. In this study we aim to translate these findings into
      man. We will test the hypothesis that in patients with STEMI undergoing PPCI, an
      intra-coronary injection of nitrite, initiated prior to establishment of full reperfusion
      reduces infarct size through prevention of ischemia-reperfusion injury.
    

Intervention name(s): Sodium Nitrite; Sodium Chloride Placebo
Intervention type(s): Drug; Drug
Intervention description(s): A bolus of sodium nitrite solution (1.8 micromol in 10 ml PRe-diluted in 0.9% sodium chloride in a syringe) will be delivered over 30-60 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).
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment