Rationale and study design of the MINERVA study: Multicentre Investigation of Novel Electrocardiogram Risk markers in Ventricular Arrhythmia prediction-UK multicentre collaboration
journal contributionposted on 2022-04-01, 08:59 authored by G Andre Ng, Amar Mistry, Michelle Newton, Fernando Soares Schlindwein, Craig Barr, Matthew GD Bates, Jane Caldwell, Moloy Das, Mohsin Farooq, Neil Herring, Pier Lambiase, Faizel Osman, Manav Sohal, Andrew Staniforth, Muzahir Tayebjee, David Tomlinson, Zachary Whinnett, Arthur Yue, Will B Nicolson
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.
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).
CitationNg GA, Mistry A, Newton M, et al, Rationale and study design of the MINERVA study: Multicentre Investigation of Novel Electrocardiogram Risk markers in Ventricular Arrhythmia prediction—UK multicentre collaboration, BMJ Open 2022;12:e059527. doi: 10.1136/bmjopen-2021-059527
Author affiliationDepartment of Cardiovascular Sciences
- VoR (Version of Record)
Published inBMJ Open
PublisherBMJ Publishing Group
Science & TechnologyLife Sciences & BiomedicineMedicine, General & InternalGeneral & Internal Medicineischaemic heart diseasepacing & electrophysiologyheart failureIMPLANTABLE CARDIOVERTER-DEFIBRILLATORACTION-POTENTIAL DURATIONSUDDEN CARDIAC DEATHSPATIAL-DISPERSIONRESTITUTIONTHERAPYSTIMULATIONALTERNANS