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Nitrites In Acute Myocardial Infarction trial
ISRCTN ISRCTN57596739
DOI 10.1186/ISRCTN57596739
ClinicalTrials.gov identifier
EudraCT number 2010-023571-26
Public title Nitrites In Acute Myocardial Infarction trial
Scientific title Does sodium nitrite administration reduce ischaemia-reperfusion injury in patients presenting with acute ST segment elevation myocardial infarction?
Acronym NIAMI
Serial number at source 9748
Study hypothesis 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)?

Where possible, written consent will be sought prior to the intervention. However in the emergency setting, verbal agreement will be sought from eligible patients.
Lay summary Not provided at time of registration
Ethics approval First MREC, 2 March 2011, ref:10/MRE00/83
Study design Randomised; Interventional; Design type: Treatment
Countries of recruitment United Kingdom
Disease/condition/study domain Cardiovascular Disease: Coronary Artery
Participants - inclusion criteria 1. Men or women
2. Aged at least 18 years to 55 years
3. Presenting within 12 hours of the onset of chest pain who have ST segment elevation of more 1mm elevation in limb leads or 2mm elevation in two contiguous chest leads and for whom the clinical decision has been made to treat with primary PCI will be eligible for enrolment
4. Occlusion of the culprit related artery (TIMI grade 0 or TIMI grade 1) will also be required for inclusion
5. Eligible patients will be of North European descent
Participants - exclusion criteria 1. Historical or ECG evidence of previous myocardial infarction
2. Patients with prior coronary artery bypass grafting (CABG)
3. Prior revascularization procedure where this procedure (PCI) was performed in the same territory as the current infarct
4. Known or suspected pregnancy
5. Contra-indications to MRI
6. Patients with cardiac arrest or cardiogenic shock
7. Patients with left main coronary occlusion
8. Patients with known moderate to severe renal failure (estimated GFR < 30mls/min), or liver failure
9. Patients with prior thrombolysis for this event
Anticipated start date 08/08/2011
Anticipated end date 31/01/2013
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants Planned Sample Size: 200; UK Sample Size: 200
Interventions 1. Treatment: sterile solution containing 70 micromol sodium nitrite dissolved in 5ml water injected intravenously over 2 and a half to 5 minutes
2. Placebo: sterile solution containing 0.9%w/v sodium chloride in 5ml water injected intravenously over 2 and a half to 5 minutes
3. The active treatment and placebo will look identical so that patients and clinical staff remain blind to the allocation
4. Followed up after 6 months
Primary outcome measure(s) The difference in final infarct size between sodium nitrite and placebo groups both measured using MRI between 10-14 days following the acute myocardial infarction and corrected for area at risk
Secondary outcome measure(s) 1. Plasma creatine kinase and Troponin I for 72 hours post MI
2. LV ejection fraction measured by MRI between days 10-14
3. LV ejection fraction measured by MRI at 6 months
4. LV end systolic volume index
Sources of funding Medical Research Council (MRC) (UK), ref: G1001340
Trial website https://www.abdn.ac.uk/chart/niami
Publications 2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/23648219
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24639423
Contact name Dr  Seonaidh  Cotton
  Address Centre for Healthcare Randomised Trials (CHaRT)
Health Services Research Unit
3rd Floor, Health Sciences Building, Polwarth Building , Foresterhill
  City/town Aberdeen
  Zip/Postcode AB25 2ZD
  Country United Kingdom
  Email s.c.cotton@abdn.ac.uk
Sponsor University of Aberdeen (UK)
  Address Research and Innovation
University Office,
King's College
  City/town Aberdeen
  Zip/Postcode AB24 3FX
  Country United Kingdom
  Tel +44 (0)1224 272 000
  Email
  Sponsor website: http://www.abdn.ac.uk/
Date applied 29/09/2011
Last edited 19/03/2014
Date ISRCTN assigned 29/09/2011
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