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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

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    Author
    Ng, G Andre
    Mistry, Amar
    Newton, Michelle
    Nicolson, Will
    Keyword
    heart failure
    ischaemic heart disease
    pacing
    electrophysiology
    Date
    2022
    
    Metadata
    Show full item record
    Publisher's URL
    https://bmjopen.bmj.com/content/12/1/e059527.long
    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.
    Citation
    Ng, 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-2021-059527
    Type
    Article
    URI
    http://hdl.handle.net/20.500.12904/15116
    Note
    Trial registration number: NCT03022487.
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    Cardiology

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