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dc.contributor.authorNg, G Andre
dc.contributor.authorMistry, Amar
dc.contributor.authorNewton, Michelle
dc.contributor.authorNicolson, Will
dc.date.accessioned2022-01-28T11:48:17Z
dc.date.available2022-01-28T11:48:17Z
dc.date.issued2022
dc.identifier.citationNg, G. A., Mistry, A., Newton, M., Schlindwein, F. S., Barr, C., Bates, M. G., Caldwell, J., Das, M., Farooq, M., Herring, N., Lambiase, P., Osman, F., Sohal, M., Staniforth, A., Tayebjee, M., Tomlinson, D., Whinnett, Z., Yue, A., & Nicolson, W. 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. https://doi.org/10.1136/bmjopen-2021-059527en_US
dc.identifier.urihttp://hdl.handle.net/20.500.12904/15116
dc.descriptionTrial registration number: NCT03022487.en_US
dc.description.abstractIntroduction: 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.
dc.description.urihttps://bmjopen.bmj.com/content/12/1/e059527.longen_US
dc.language.isoenen_US
dc.subjectheart failureen_US
dc.subjectischaemic heart diseaseen_US
dc.subjectpacingen_US
dc.subjectelectrophysiologyen_US
dc.titleRationale and study design of the MINERVA study: Multicentre Investigation of Novel Electrocardiogram Risk markers in Ventricular Arrhythmia prediction-UK multicentre collaborationen_US
dc.typeArticleen_US
rioxxterms.funderDefault funderen_US
rioxxterms.identifier.projectDefault projecten_US
rioxxterms.versionVoRen_US
rioxxterms.versionofrecord10.1136/bmjopen-2021-059527en_US
rioxxterms.typeJournal Article/Reviewen_US
refterms.dateFCD2022-01-28T11:48:17Z
refterms.versionFCDVoR
refterms.dateFOA2022-01-28T11:48:17Z
refterms.panelUnspecifieden_US
refterms.dateFirstOnline2022-01
html.description.abstractIntroduction: 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.en_US
rioxxterms.funder.project94a427429a5bcfef7dd04c33360d80cden_US


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