ISRCTN ISRCTN57596739
DOI https://doi.org/10.1186/ISRCTN57596739
EudraCT/CTIS number 2010-023571-26
Secondary identifying numbers 9748
Submission date
29/09/2011
Registration date
29/09/2011
Last edited
19/03/2014
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Dr Seonaidh Cotton
Scientific

Centre for Healthcare Randomised Trials (CHaRT)
Health Services Research Unit
3rd Floor, Health Sciences Building, Polwarth Building , Foresterhill
Aberdeen
AB25 2ZD
United Kingdom

Email s.c.cotton@abdn.ac.uk

Study information

Study designRandomised; Interventional; Design type: Treatment
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)GP practice
Study typeDiagnostic
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleDoes sodium nitrite administration reduce ischaemia-reperfusion injury in patients presenting with acute ST segment elevation myocardial infarction?
Study acronymNIAMI
Study objectivesDoes 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.
Ethics approval(s)First MREC, 2 March 2011, ref:10/MRE00/83
Health condition(s) or problem(s) studiedCardiovascular Disease: Coronary Artery
Intervention1. 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
Intervention typeOther
Primary outcome measureThe 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 measures1. 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
Overall study start date08/08/2011
Completion date31/01/2013

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participantsPlanned Sample Size: 200; UK Sample Size: 200
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment08/08/2011
Date of final enrolment31/01/2013

Locations

Countries of recruitment

  • Scotland
  • United Kingdom

Study participating centre

Centre for Healthcare Randomised Trials (CHaRT)
Aberdeen
AB25 2ZD
United Kingdom

Sponsor information

University of Aberdeen (UK)
University/education

Research and Innovation
University Office
King's College
Aberdeen
AB24 3FX
Scotland
United Kingdom

Phone +44 (0)1224 272 000
Website http://www.abdn.ac.uk/
ROR logo "ROR" https://ror.org/016476m91

Funders

Funder type

Research council

Medical Research Council (MRC) (UK), ref: G1001340
Government organisation / National government
Alternative name(s)
Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 06/05/2013 Yes No
Results article results 14/05/2014 Yes No
HRA research summary 28/06/2023 No No