Condition category
Circulatory System
Date applied
29/09/2011
Date assigned
29/09/2011
Last edited
19/03/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

https://www.abdn.ac.uk/chart/niami

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 measures

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

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

http://www.abdn.ac.uk/

Funders

Funder type

Research council

Funder name

Medical Research Council (MRC) (UK), ref: G1001340

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

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

Results - basic reporting

Publication summary

2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/23648219
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24639423

Publication citations

  1. 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.

  2. 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.

Additional files

Editorial Notes