Clinical trial NCT03022487: Multicentre Investigation of Novel Electrocardiogram Risk Markers in Ventricular Arrhythmia Prediction
Official title: Multicentre Investigation of Novel Electrocardiogram Risk Markers in Ventricular Arrhythmia Prediction (MINERVA)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ventricular Arrythmia
Ischemic Cardiomyopathy
Keywords: Sudden Cardiac Death (SCD)
implantable cardioverter defibrillator
electrophysiological
EP
Ischaemic cardiomyopathy
Ventricular Arrhythmia
ICD
Lead sponsor: University of Leicester
Sponsor class: OTHER
First posted: 2017-01-16
Enrollment: 395
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 440 patients with Ischaemic cardiomyopathy being fitted with an implantable cardioverter-defibrillator (ICDs)

Brief summary: This is a prospective open label single blinded multi-centre observational study involving a study group of patients already undergoing implantable cardioverter-defibrillator (ICD)(including Cardiac resynchronisation therapy device (CRT-D)) implant. A standard 30-minute electrophysiological (EP) cardiac stimulation protocol will be performed at the end of the ICD implant at baseline. This EP test will be performed whilst measuring a 12-lead ECG and will be correlated with event rates to establish their effectiveness in predicting arrhythmia risk. The minimum follow up period should be 18 months and maximum of 3 years, which is how long the study is funded for. This study is not randomised as all study patients will be receiving the EP study performed at baseline. A minimum of 440 patients will be recruited to document event data at standard clinical ICD follow up intervals - equating to a maximum of 6 visits. Blinding will be maintained at the core lab were the ECG analysis will be performed by a nominated researcher who will not have details of patient health status.


Eligibility criteria: Inclusion Criteria:

* Participant is willing and able to give informed consent for participation in the study
* Male or Female, aged 18 years or above
* Female participants of child bearing potential must be willing to ensure that they or their partner use effective contraception during the study
* Diagnosed with a history of ischaemic cardiomyopathy
* Stable, as define as no more than a 100% increase or a 50% decrease, dose of current regular medication as standard for patients at risk of ventricular arrhythmia for at least 4 weeks prior to study entry
* Able (in the Investigators opinion) and willing to comply with all study requirements
* Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study
* Patients must be able to attend follow up at the study site until the study closure
* Attending for first time primary prevention ICD (including CRT-D) implantation under THE National Institute for Health and Care Excellence (NICE) criteria
* Patients must be able to read and understand English
* Stable dose of current regular medication for at least 4 weeks prior to study entry

Exclusion Criteria:

* Within 28 days since acute coronary syndrome/cardiac surgery
* Scheduled elective surgery or other procedures requiring general anaesthesia during the study: for example - awaiting coronary revascularisation
* Female participants who are pregnant, lactating or planning pregnancy during the course of the study
* Contraindications for electrophysiological study

  * Haemodynamic instability
  * Severe valvular heart disease as define by British Society of Echocardiography (BSE) guidelines
  * Symptomatic coronary artery disease (unstable or refractory angina)
  * Stroke within the last 12 months
* Significant renal disease stage i.e. Chronic Kidney Disease stage 5 (requiring renal replacement therapy and / or Estimated glomerular filtration rate (eGFR) \<15), or severe liver disease (end stage or presence of cirrhosis)
* Participants who have participated in another research study involving an investigational product in the past 12 weeks
* Undergone ICD implantation where the right ventricular lead is non-apically positioned e.g. positioned septally
* Clinically judged by a cardiologist to require a ventricular tachycardia (VT) therapy zone less than or equal to 200 bpm
* Any other significant disease or disorders which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study. Specific concerns should be discussed with the Chief / Co - Investigators
* Any other interventional research

Primary outcomes:
measure: Regional Restitution Instability Index (R2I2), the mean of the standard deviation of the residuals from the mean gradients for each ECG lead across a range of diastolic intervals, will be determined from an EP study carried out at ICD implant.
timeFrame: 12 - 36 months
measure: Peak ECG Restitution Slope (PERS), calculated as the peak restitution curve slope taken as a mean across the 12 ECG leads .
timeFrame: 12 - 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cottingham
country: United Kingdom
facility: Hull and East Yorkshire Hospitals NHS Trust
city: Dudley
country: United Kingdom
facility: The Dudley Group NHS Foundation Trust
city: Leeds
country: United Kingdom
facility: Leeds Teaching Hospitals NHS Trust
city: Leicester
country: United Kingdom
facility: University Hospitals of Leicester NHS Trust
city: London
country: United Kingdom
facility: Barts Health NHS Trust
city: London
country: United Kingdom
facility: Imperial college Healthcare NHS Trust
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals NHS Foundation Trust
Study officials:
affiliation: University of Leicester
name: G. André Ng
role: STUDY_CHAIR
References:
citation: Ng GA, Mistry A, Newton M, Schlindwein FS, Barr C, Bates MG, 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 WB. 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 Jan 3;12(1):e059527. doi: 10.1136/bmjopen-2021-059527.