MINERVA UK Multicentre Investigation
Research type
Research Study
Full title
Multicentre Investigation of Novel Electrocardiogram Risk markers in Ventricular Arrhythmia prediction – UK multicentre collaboration "MINERVA"
IRAS ID
186618
Contact name
G. Andre Ng
Contact email
Sponsor organisation
University of Leicester
Duration of Study in the UK
3 years, 0 months, 0 days
Research summary
Research Summary
Sudden cardiac death (SCD) is responsible for over 3 million deaths worldwide annually. These deaths could be prevented with implantable cardioverter defibrillators (ICDs). Choosing appropriate patients for ICDs can be extremely difficult, leading to patients who we think are “high-risk” receiving ICDs without ever using them, while the majority of SCD occurs in a large population regarded as “low-risk”.
At Leicester we have developed the Regional Restitution Instability Index (R2I2) and Peak ECG Restitution Slope (PERS). These are numerical values of cardiac risk, based on the electrocardiogram (ECG) which is a simple everyday test performed to record the rhythm and electrical activity of the heart. R2I2 and PERS take into account subtle differences in the electrical properties around different regions of the heart. We have already shown these tools to be effective in a series of small studies performed at Leicester that were recently published.
The study will recruit patients from the some of the UK’s leading specialist cardiac centres. Suitable patients will include those enlisted for ICD implants who also have ischaemic heart disease (caused by narrowing of arteries). Entering the study will involve an extra test performed during ECG recording at the time of ICD implant via the ICD device itself. The test is not painful, will not involve extra visits to the hospital and will take around 20 minutes to perform. The stored data is analysed to calculate R2I2 and PERS and values are later correlated with patient outcomes.
R2I2 and PERS are simple and inexpensive to perform. If the findings from our previous studies are replicated, we will move closer to being able to incorporate them into clinical practice. Implementing these tests in patients being considered for ICDs has the potential to save lives and reduce the burden of harm and cost by improving the allocation of ICDs.
Summary of Results
MINERVA recruited 395 patients from 15 of the leading specialist cardiac centres in the UK. Out of 395 patients, the minimum number of 22 participants for reaching endpoints had been met, no further recruitment was carried out. 28 patients were ineligible and did not undergo the baseline assessment – therefore no data was collected for them. The study is now closed to recruitment, and final follow-up visits were conducted. Participants include those enlisted for ICD and CRT-D implants who also have coronary heart disease. Every participant has undergone an ECG carried out during their implant, which is currently being analysed to calculate numerical values for cardiac risk, due to report in December 2023. These cardiac risk scores will then be compared with how often abnormal heart rhythms occur during an 18-month follow-up period.
REC name
HSC REC B
REC reference
16/NI/0069
Date of REC Opinion
17 May 2016
REC opinion
Further Information Favourable Opinion