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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)

Siddiqi, N; Bruce, M; Neil, CJ; Jagpal, B; Maclennon, G; Cotton, SC; Papadopoulo, SA; Bunce, N; Lim, P; Schwarz, K; et al. 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 (2013) 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). JOURNAL OF TRANSLATIONAL MEDICINE, 11 (116). ISSN 1479-5876 https://doi.org/10.1186/1479-5876-11-116
SGUL Authors: Kaski, Juan Carlos Bunce, Nicholas Harry

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Abstract

BACKGROUND: Whilst advances in reperfusion therapies have reduced early mortality from acute myocardial infarction, heart failure remains a common complication, and may develop very early or long after the acute event. Reperfusion itself leads to further tissue damage, a process described as ischaemia-reperfusion-injury (IRI), which contributes up to 50% of the final infarct size. In experimental models nitrite administration potently protects against IRI in several organs, including the heart. In the current study we investigate whether intravenous sodium nitrite administration immediately prior to percutaneous coronary intervention (PCI) in patients with acute ST segment elevation myocardial infarction will reduce myocardial infarct size. This is a phase II, randomised, placebo-controlled, double-blinded and multicentre trial. METHODS AND OUTCOMES: The aim of this trial is to determine whether a 5 minute systemic injection of sodium nitrite, administered immediately before opening of the infarct related artery, results in significant reduction of IRI in patients with first acute ST elevation myocardial infarction (MI). The primary clinical end point is the difference in infarct size between sodium nitrite and placebo groups measured using cardiovascular magnetic resonance imaging (CMR) performed at 6-8 days following the AMI and corrected for area at risk (AAR) using the endocardial surface area technique. Secondary end points include (i) plasma creatine kinase and Troponin I measured in blood samples taken pre-injection of the study medication and over the following 72 hours; (ii) infarct size at six months; (iii) Infarct size corrected for AAR measured at 6-8 days using T2 weighted triple inversion recovery (T2-W SPAIR or STIR) CMR imaging; (iv) Left ventricular (LV) ejection fraction measured by CMR at 6-8 days and six months following injection of the study medication; and (v) LV end systolic volume index at 6-8 days and six months. FUNDING,ETHICS AND REGULATORY APPROVALS: This study is funded by a grant from the UK Medical Research Council. This protocol is approved by the Scotland A Research Ethics Committee and has also received clinical trial authorisation from the Medicines and Healthcare products Regulatory Agency (MHRA) (EudraCT number: 2010-023571-26).

Item Type: Article
Additional Information: PubMed ID: 23648219 © 2013 Siddiqi et al.; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Keywords: Science & Technology, Life Sciences & Biomedicine, Medicine, Research & Experimental, Research & Experimental Medicine, Ischaemia-reperfusion-injury, Myocardial infarction, Sodium nitrite, Primary percutaneous coronary intervention, Cardioprotection, THERAPY, MECHANISMS, HEART, OXIDE, ANGIOPLASTY, ADMISSION, SURVIVORS, SALVAGE
SGUL Research Institute / Research Centre: Academic Structure > Molecular and Clinical Sciences Research Institute (MCS)
Journal or Publication Title: JOURNAL OF TRANSLATIONAL MEDICINE
ISSN: 1479-5876
Dates:
DateEvent
6 May 2013Published
PubMed ID: 23648219
Web of Science ID: 23648219
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URI: https://openaccess.sgul.ac.uk/id/eprint/101208
Publisher's version: https://doi.org/10.1186/1479-5876-11-116

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