Plain English Summary
Not provided at time of registration
Trial website
Contact information
Type
Scientific
Primary contact
Dr Seonaidh Cotton
ORCID ID
Contact details
Centre for Healthcare Randomised Trials (CHaRT)
Health Services Research Unit
3rd Floor
Health Sciences Building
Polwarth Building
Foresterhill
Aberdeen
AB25 2ZD
United Kingdom
s.c.cotton@abdn.ac.uk
Additional identifiers
EudraCT number
2010-023571-26
ClinicalTrials.gov number
Protocol/serial number
9748
Study information
Scientific title
Does sodium nitrite administration reduce ischaemia-reperfusion injury in patients presenting with acute ST segment elevation myocardial infarction?
Acronym
NIAMI
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.
Ethics approval
First MREC, 2 March 2011, ref:10/MRE00/83
Study design
Randomised; Interventional; Design type: Treatment
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Cardiovascular Disease: Coronary Artery
Intervention
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
Intervention type
Other
Phase
Phase II/III
Drug names
Primary outcome measure
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 measures
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
Overall trial start date
08/08/2011
Overall trial end date
31/01/2013
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 200; UK Sample Size: 200
Participant 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
Recruitment start date
08/08/2011
Recruitment end date
31/01/2013
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Centre for Healthcare Randomised Trials (CHaRT)
Aberdeen
AB25 2ZD
United Kingdom
Sponsor information
Organisation
University of Aberdeen (UK)
Sponsor details
Research and Innovation
University Office
King's College
Aberdeen
AB24 3FX
United Kingdom
+44 (0)1224 272 000
Sponsor type
University/education
Website
Funders
Funder type
Research council
Funder name
Medical Research Council (MRC) (UK), ref: G1001340
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/23648219
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24639423
Publication citations
-
Protocol
Siddiqi N, Bruce M, Neil CJ, Jagpal B, Maclennon G, Cotton SC, Papadopoulo SA, Bunce N, Lim P, Schwarz K, Singh S, Hildick-Smith D, Horowitz JD, Madhani M, Boon N, Kaski JC, Dawson D, Frenneaux MP, Protocol: does sodium nitrite administration reduce ischaemia-reperfusion injury in patients presenting with acute ST segment elevation myocardial infarction? Nitrites in acute myocardial infarction (NIAMI)., J Transl Med, 2013, 11, 116, doi: 10.1186/1479-5876-11-116.
-
Results
Siddiqi N, Neil C, Bruce M, MacLennan G, Cotton S, Papadopoulou S, Feelisch M, Bunce N, Lim PO, Hildick-Smith D, Horowitz J, Madhani M, Boon N, Dawson D, Kaski JC, Frenneaux M, , Intravenous sodium nitrite in acute ST-elevation myocardial infarction: a randomized controlled trial (NIAMI)., Eur. Heart J., 2014, 35, 19, 1255-1262, doi: 10.1093/eurheartj/ehu096.