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Rationale and study design of the MINERVA study: Multicentre Investigation of Novel Electrocardiogram Risk markers in Ventricular Arrhythmia prediction-UK multicentre collaboration

Rationale and study design of the MINERVA study: Multicentre Investigation of Novel Electrocardiogram Risk markers in Ventricular Arrhythmia prediction-UK multicentre collaboration
Rationale and study design of the MINERVA study: Multicentre Investigation of Novel Electrocardiogram Risk markers in Ventricular Arrhythmia prediction-UK multicentre collaboration

Introduction: the purpose of this study is to assess the ability of two new ECG markers (Regional Repolarisation Instability Index (R2I2) and Peak Electrical Restitution Slope) to predict sudden cardiac death (SCD) or ventricular arrhythmia (VA) events in patients with ischaemic cardiomyopathy undergoing implantation of an implantable cardioverter defibrillator for primary prevention indication. 

Methods and analysis: multicentre Investigation of Novel Electrocardiogram Risk markers in Ventricular Arrhythmia prediction is a prospective, open label, single blinded, multicentre observational study to establish the efficacy of two ECG biomarkers in predicting VA risk. 440 participants with ischaemic cardiomyopathy undergoing routine first time implantable cardioverter-defibrillator (ICD) implantation for primary prevention indication are currently being recruited. An electrophysiological (EP) study is performed using a non-invasive programmed electrical stimulation protocol via the implanted device. All participants will undergo the EP study hence no randomisation is required. Participants will be followed up over a minimum of 18 months and up to 3 years. The first patient was recruited in August 2016 and the study will be completed at the final participant follow-up visit. The primary endpoint is ventricular fibrillation or sustained ventricular tachycardia >200 beats/min as recorded by the ICD. The secondary endpoint is SCD. Analysis of the ECG data obtained during the EP study will be performed by the core lab where blinding of patient health status and endpoints will be maintained. 

Ethics and dissemination: ethical approval has been granted by Research Ethics Committees Northern Ireland (reference no. 16/NI/0069). The results will inform the design of a definitive Randomised Controlled Trial (RCT). Dissemination will include peer reviewed journal articles reporting the qualitative and quantitative results, as well as presentations at conferences and lay summaries.

Heart failure, Ischaemic heart disease, Pacing & electrophysiology
2044-6055
e059527
Ng, G Andre
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Mistry, Amar
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Newton, Michelle
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Schlindwein, Fernando Soares
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Barr, Craig
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Bates, Matthew Gd
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Caldwell, Jane
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Das, Moloy
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Farooq, Mohsin
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Herring, Neil
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Lambiase, Pier
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Osman, Faizel
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Sohal, Manav
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Staniforth, Andrew
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Tayebjee, Muzahir
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Tomlinson, David
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Whinnett, Zachary
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Yue, Arthur
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Nicolson, Will B
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Ng, G Andre
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Mistry, Amar
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Newton, Michelle
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Schlindwein, Fernando Soares
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Barr, Craig
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Bates, Matthew Gd
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Caldwell, Jane
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Das, Moloy
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Farooq, Mohsin
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Herring, Neil
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Lambiase, Pier
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Osman, Faizel
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Sohal, Manav
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Staniforth, Andrew
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Tayebjee, Muzahir
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Tomlinson, David
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Whinnett, Zachary
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Yue, Arthur
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Nicolson, Will B
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Ng, G Andre, Mistry, Amar, Newton, Michelle, Schlindwein, Fernando Soares, Barr, Craig, Bates, Matthew Gd, Caldwell, Jane, Das, Moloy, Farooq, Mohsin, Herring, Neil, Lambiase, Pier, Osman, Faizel, Sohal, Manav, Staniforth, Andrew, Tayebjee, Muzahir, Tomlinson, David, Whinnett, Zachary, Yue, Arthur and Nicolson, Will B (2022) Rationale and study design of the MINERVA study: Multicentre Investigation of Novel Electrocardiogram Risk markers in Ventricular Arrhythmia prediction-UK multicentre collaboration. BMJ Open, 12 (1), e059527, [e059527]. (doi:10.1136/bmjopen-2021-059527).

Record type: Article

Abstract

Introduction: the purpose of this study is to assess the ability of two new ECG markers (Regional Repolarisation Instability Index (R2I2) and Peak Electrical Restitution Slope) to predict sudden cardiac death (SCD) or ventricular arrhythmia (VA) events in patients with ischaemic cardiomyopathy undergoing implantation of an implantable cardioverter defibrillator for primary prevention indication. 

Methods and analysis: multicentre Investigation of Novel Electrocardiogram Risk markers in Ventricular Arrhythmia prediction is a prospective, open label, single blinded, multicentre observational study to establish the efficacy of two ECG biomarkers in predicting VA risk. 440 participants with ischaemic cardiomyopathy undergoing routine first time implantable cardioverter-defibrillator (ICD) implantation for primary prevention indication are currently being recruited. An electrophysiological (EP) study is performed using a non-invasive programmed electrical stimulation protocol via the implanted device. All participants will undergo the EP study hence no randomisation is required. Participants will be followed up over a minimum of 18 months and up to 3 years. The first patient was recruited in August 2016 and the study will be completed at the final participant follow-up visit. The primary endpoint is ventricular fibrillation or sustained ventricular tachycardia >200 beats/min as recorded by the ICD. The secondary endpoint is SCD. Analysis of the ECG data obtained during the EP study will be performed by the core lab where blinding of patient health status and endpoints will be maintained. 

Ethics and dissemination: ethical approval has been granted by Research Ethics Committees Northern Ireland (reference no. 16/NI/0069). The results will inform the design of a definitive Randomised Controlled Trial (RCT). Dissemination will include peer reviewed journal articles reporting the qualitative and quantitative results, as well as presentations at conferences and lay summaries.

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Accepted/In Press date: 8 December 2021
Published date: 3 January 2022
Additional Information: Funding Information: Funding This work was supported by a restricted grant from Heart Research UK (RG2649/15/18). GAN is supported by a British Heart Foundation Programme Grant (RG/17/3/32774). GAN and WBN are supported by a Medical Research Council Biomedical Catalyst, Developmental Pathway Funding Scheme Award (MR/ S037306/1). Funding Information: Competing interests The University of Leicester has applied for a patent for the R2I2 and PERS ECG markers on behalf of WBN and GAN. GAN reports research fellow support from Boston Scientific Ltd and Abbott Ltd.AM’s salary is supported by Abbott (formerly St Jude Medical). Funding Information: 1Department of Cardiovascular Sciences, University of Leicester, Leicester, UK 2NIHR Leicester Biomedical Research Centre Cardiovascular Diseases, Leicester, UK 3Department of Cardiology, University Hospitals of Leicester NHS Trust, Leicester, UK 4Department of Engineering, University of Leicester, Leicester, UK 5Cardiology, Dudley Group NHS Foundation Trust, Dudley, UK 6Cardiology, South Tees Hospitals NHS Trust, Middlesbrough, UK 7Cardiology, Castle Hill Hosptial, Hull and East Yorkshire NHS Trust, Hull, UK 8Cardiology, Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle Upon Tyne, UK 9Cardiology, Kettering General Hospital, Kettering, UK 10Cardiology, Oxford University Hospitals NHS Foundation Trust, Oxford, UK 11Cardiology, University College London Hospitals NHS Foundation Trust, London, UK 12Cardiology, University Hospitals Coventry and Warwickshire NHS Trust, Coventry, UK 13Cardiology, University Hospitals Plymouth NHS Trust, Plymouth, UK 14Cardiology, Imperial College Healthcare NHS Trust, London, UK 15Cardiology, University Hospital Southampton, Southampton, UK Acknowledgements The development of R2I2 and PERS includes studies which are part of the research portfolio supported by the National Institute for Health Research Leicester Biomedical Research Centre. Publisher Copyright: © Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. Copyright: Copyright 2022 Elsevier B.V., All rights reserved.
Keywords: Heart failure, Ischaemic heart disease, Pacing & electrophysiology

Identifiers

Local EPrints ID: 455481
URI: http://eprints.soton.ac.uk/id/eprint/455481
ISSN: 2044-6055
PURE UUID: 875a6a39-bdf8-4d31-ac74-6e12dccb8934

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Date deposited: 22 Mar 2022 17:44
Last modified: 16 Mar 2024 16:14

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Contributors

Author: G Andre Ng
Author: Amar Mistry
Author: Michelle Newton
Author: Fernando Soares Schlindwein
Author: Craig Barr
Author: Matthew Gd Bates
Author: Jane Caldwell
Author: Moloy Das
Author: Mohsin Farooq
Author: Neil Herring
Author: Pier Lambiase
Author: Faizel Osman
Author: Manav Sohal
Author: Andrew Staniforth
Author: Muzahir Tayebjee
Author: David Tomlinson
Author: Zachary Whinnett
Author: Arthur Yue
Author: Will B Nicolson

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