Evidence map›Paper›PMID 25512434›Full record

Trial reportCirculation research2015

Randomized phase 2 trial of intracoronary nitrite during acute myocardial infarction.

Daniel A Jones, Cyril Pellaton, Shanti Velmurugan, Krishnaraj Sinha Rathod, Mervyn Andiapen, Sotiris Antoniou, Sven van Eijl, Andrew J Webb, Mark A Westwood, Mahesh K Parmar and 2 more

Erratum issued 3 registry-linked trialsOpen access · bronzeAbstract readClinical Trial, Phase IIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Circulation research, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 3 registered trials, which are not on this map. Cited by 46 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
46citing papers in PubMed, 1 pooled it
8.4field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01584453 phase2completednot on this map

A Randomised, Double-blind, Placebo-controlled Trial Assessing the Safety and Efficacy of Intracoronary Nitrite Infusion During Acute Myocardial Infarction

TypeinterventionalSponsorBarts & The London NHS TrustRan2012 to 2016Enrolled80ConditionsMyocardial Infarction, Reperfusion Injury, Myocardial Ischemia, Cardiovascular DiseasesArmsSodium Nitrite, Sodium Chloride Placebo
NCT03183830 phase1completednot on this mapstarted 2017, after this paper: background citation

A Double-blind, Randomised, Placebo-controlled Parallel Study to Investigate the Influence of Dietary Nitrate on Skin Inflammation in Healthy Volunteers

TypeinterventionalSponsorQueen Mary University of LondonRan2017 to 2020Enrolled24ConditionsCardiovascular Diseases, Inflammation, Inflammation, SkinArmsNitrate-rich Beetroot Juice, Nitrate-deplete Beetroot Juice
NCT03511248 phase2terminatednot on this mapstarted 2018, after this paper: background citation

Investigation of Dietary Nitrate Optimisation by Hyperuricaemia Stratification in Heart Failure

TypeinterventionalSponsorQueen Mary University of LondonRan2018 to 2025Enrolled2ConditionsHeart Failure, Heart Failure, SystolicArmsNitrate-rich Beetroot Juice, Nitrate-deplete Beetroot Juice
3 · Its place in the literature

Who cites it

46 citing papers in PubMed, 1 synthesis or guideline pooled it, 107 citations in OpenAlex.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

12 authors at 2 institutions in 1 country.

Daniel A JonesFrom the Barts National Institute for Health Research Cardiovascular Biomedical Research Unit, William Harvey Research Institute, Barts and The London Medical School (D.A.J., S.V., K.S.R., S.A., S.v.E., A.J.W., A.M., A.A.); and Department of Cardiology, London Chest Hospital, Barts Health NHS Trust (D.A.J., C.P., S.V., M.A., M.A.W., A.M.), and MRC Clinical Trials Unit at UCL (M.K.P.), University College London, Aviation House, Kingsway, London, UK.
Cyril PellatonFrom the Barts National Institute for Health Research Cardiovascular Biomedical Research Unit, William Harvey Research Institute, Barts and The London Medical School (D.A.J., S.V., K.S.R., S.A., S.v.E., A.J.W., A.M., A.A.); and Department of Cardiology, London Chest Hospital, Barts Health NHS Trust (D.A.J., C.P., S.V., M.A., M.A.W., A.M.), and MRC Clinical Trials Unit at UCL (M.K.P.), University College London, Aviation House, Kingsway, London, UK.
Shanti VelmuruganFrom the Barts National Institute for Health Research Cardiovascular Biomedical Research Unit, William Harvey Research Institute, Barts and The London Medical School (D.A.J., S.V., K.S.R., S.A., S.v.E., A.J.W., A.M., A.A.); and Department of Cardiology, London Chest Hospital, Barts Health NHS Trust (D.A.J., C.P., S.V., M.A., M.A.W., A.M.), and MRC Clinical Trials Unit at UCL (M.K.P.), University College London, Aviation House, Kingsway, London, UK.
Krishnaraj Sinha RathodFrom the Barts National Institute for Health Research Cardiovascular Biomedical Research Unit, William Harvey Research Institute, Barts and The London Medical School (D.A.J., S.V., K.S.R., S.A., S.v.E., A.J.W., A.M., A.A.); and Department of Cardiology, London Chest Hospital, Barts Health NHS Trust (D.A.J., C.P., S.V., M.A., M.A.W., A.M.), and MRC Clinical Trials Unit at UCL (M.K.P.), University College London, Aviation House, Kingsway, London, UK.
Mervyn AndiapenFrom the Barts National Institute for Health Research Cardiovascular Biomedical Research Unit, William Harvey Research Institute, Barts and The London Medical School (D.A.J., S.V., K.S.R., S.A., S.v.E., A.J.W., A.M., A.A.); and Department of Cardiology, London Chest Hospital, Barts Health NHS Trust (D.A.J., C.P., S.V., M.A., M.A.W., A.M.), and MRC Clinical Trials Unit at UCL (M.K.P.), University College London, Aviation House, Kingsway, London, UK.
Sotiris AntoniouFrom the Barts National Institute for Health Research Cardiovascular Biomedical Research Unit, William Harvey Research Institute, Barts and The London Medical School (D.A.J., S.V., K.S.R., S.A., S.v.E., A.J.W., A.M., A.A.); and Department of Cardiology, London Chest Hospital, Barts Health NHS Trust (D.A.J., C.P., S.V., M.A., M.A.W., A.M.), and MRC Clinical Trials Unit at UCL (M.K.P.), University College London, Aviation House, Kingsway, London, UK.
Sven van EijlFrom the Barts National Institute for Health Research Cardiovascular Biomedical Research Unit, William Harvey Research Institute, Barts and The London Medical School (D.A.J., S.V., K.S.R., S.A., S.v.E., A.J.W., A.M., A.A.); and Department of Cardiology, London Chest Hospital, Barts Health NHS Trust (D.A.J., C.P., S.V., M.A., M.A.W., A.M.), and MRC Clinical Trials Unit at UCL (M.K.P.), University College London, Aviation House, Kingsway, London, UK.
Andrew J WebbFrom the Barts National Institute for Health Research Cardiovascular Biomedical Research Unit, William Harvey Research Institute, Barts and The London Medical School (D.A.J., S.V., K.S.R., S.A., S.v.E., A.J.W., A.M., A.A.); and Department of Cardiology, London Chest Hospital, Barts Health NHS Trust (D.A.J., C.P., S.V., M.A., M.A.W., A.M.), and MRC Clinical Trials Unit at UCL (M.K.P.), University College London, Aviation House, Kingsway, London, UK.
Mark A WestwoodFrom the Barts National Institute for Health Research Cardiovascular Biomedical Research Unit, William Harvey Research Institute, Barts and The London Medical School (D.A.J., S.V., K.S.R., S.A., S.v.E., A.J.W., A.M., A.A.); and Department of Cardiology, London Chest Hospital, Barts Health NHS Trust (D.A.J., C.P., S.V., M.A., M.A.W., A.M.), and MRC Clinical Trials Unit at UCL (M.K.P.), University College London, Aviation House, Kingsway, London, UK.
Mahesh K ParmarFrom the Barts National Institute for Health Research Cardiovascular Biomedical Research Unit, William Harvey Research Institute, Barts and The London Medical School (D.A.J., S.V., K.S.R., S.A., S.v.E., A.J.W., A.M., A.A.); and Department of Cardiology, London Chest Hospital, Barts Health NHS Trust (D.A.J., C.P., S.V., M.A., M.A.W., A.M.), and MRC Clinical Trials Unit at UCL (M.K.P.), University College London, Aviation House, Kingsway, London, UK.
Anthony MathurFrom the Barts National Institute for Health Research Cardiovascular Biomedical Research Unit, William Harvey Research Institute, Barts and The London Medical School (D.A.J., S.V., K.S.R., S.A., S.v.E., A.J.W., A.M., A.A.); and Department of Cardiology, London Chest Hospital, Barts Health NHS Trust (D.A.J., C.P., S.V., M.A., M.A.W., A.M.), and MRC Clinical Trials Unit at UCL (M.K.P.), University College London, Aviation House, Kingsway, London, UK.
Amrita AhluwaliaFrom the Barts National Institute for Health Research Cardiovascular Biomedical Research Unit, William Harvey Research Institute, Barts and The London Medical School (D.A.J., S.V., K.S.R., S.A., S.v.E., A.J.W., A.M., A.A.); and Department of Cardiology, London Chest Hospital, Barts Health NHS Trust (D.A.J., C.P., S.V., M.A., M.A.W., A.M.), and MRC Clinical Trials Unit at UCL (M.K.P.), University College London, Aviation House, Kingsway, London, UK. a.ahluwalia@qmul.ac.uk.
William Harvey Research Institute · GBNational Institute for Health Research · GB

Funding

British Heart Foundation FS/11/41/28749British Heart Foundation PG/04/045/16956British Heart Foundation PG/10/28/28320British Heart Foundation SP/08/006/25110Department of Health DRF-2011-04-080Department of Health DRF-2014-07-008
6 · The paper itself

Abstract

rationalePreclinical evidence demonstrates that inorganic nitrite, after its in situ conversion to nitric oxide, attenuates consequent myocardial reperfusion injury.

objectiveWe investigated whether intracoronary injection of nitrite during primary percutaneous coronary intervention might improve infarct size in ST-elevated myocardial infarction. METHODS AND

resultsPatients undergoing primary percutaneous coronary intervention (n=80) were randomized to receive intracoronary (10 mL) sodium nitrite (1.8 μmol) or NaCl (placebo) before balloon inflation. The primary end point was infarct size assessed by measuring creatine kinase release. Secondary outcomes included infarct size assessed by troponin T release and by cardiac MRI on day 2. Baseline characteristics were similar between the groups. No evidence of differences in creatine kinase release (P=0.92), troponin T (P=0.85), or cardiac MRI-assessed infarct size (P=0.254) were evident. In contrast, there was an improvement [corrected] in myocardial salvage index (P=0.05) and reduction in [corrected] major adverse cardiac event at 1 year (2.6% versus 15.8%; P=0.04) in the nitrite group. In a 66-patient subgroup with thrombolysis in myocardial infarction ≤1 flow, there was reduced serum creatine kinase (P=0.030) and a 19% reduction in cardiac MRI-determined infarct size (P=0.034) with nitrite. No adverse effects of nitrite were detected.

conclusionsIn this phase II study, intracoronary nitrite infusion did not alter infarct size, although a trend to improved myocardial salvage index and a significant reduction in major adverse cardiac event was evident. In a subgroup of patients with thrombolysis in myocardial infarction flow ≤1, nitrite reduced infarct size and major adverse cardiac event and improved myocardial salvage index, indicating that a phase III clinical trial assessing intracoronary nitrite administration as an adjunct to percutaneous coronary intervention in ST-elevated myocardial infarction patients is warranted. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT01584453.

Indexed as

AgedFemaleHumansMaleMiddle AgedMyocardial InfarctionSodium NitriteSodium Nitriteacute myocardial infarctionnitric oxidepercutaneous coronary intervention

Identifiers

PMID25512434
PMCPMC4340586
OpenAlexW1995749170

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.