Nitrites In Acute Myocardial Infarction trial
| 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
Contact information
Dr Seonaidh Cotton
Scientific
Scientific
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 |
Study information
| Study design | Randomised; Interventional; Design type: Treatment |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Does sodium nitrite administration reduce ischaemia-reperfusion injury in patients presenting with acute ST segment elevation myocardial infarction? |
| Study acronym | NIAMI |
| Study objectives | 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(s) | First MREC, 2 March 2011, ref:10/MRE00/83 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 08/08/2011 |
| Completion date | 31/01/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 200; UK Sample Size: 200 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 08/08/2011 |
| Date of final enrolment | 31/01/2013 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
Centre for Healthcare Randomised Trials (CHaRT)
Aberdeen
AB25 2ZD
United Kingdom
AB25 2ZD
United Kingdom
Sponsor information
University of Aberdeen (UK)
University/education
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" |
https://ror.org/016476m91 |
Funders
Funder type
Research council
Medical Research Council (MRC) (UK), ref: G1001340
Government organisation / National government
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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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 |
