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| ID | Type | Description | Link |
|---|---|---|---|
| 186618 | Other Identifier | IRAS Number | |
| 16/NI/0069 | Other Identifier | Ethics Reference |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ICD Patients with Ischaemic cardiomyopathy | A standard 30-minute electrophysiological (EP) cardiac stimulation protocol will be performed at the end of the ICD implant at baseline. Participants will be followed up for at least 12 months for endpoints. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| 12 - 36 months |
| Peak ECG Restitution Slope (PERS), calculated as the peak restitution curve slope taken as a mean across the 12 ECG leads . | A PERS cut-off of 1.21 (no units) will partition the study population into high and low risk groups. | 12 - 36 months |
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Inclusion Criteria:
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
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
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440 patients with Ischaemic cardiomyopathy being fitted with an implantable cardioverter-defibrillator (ICDs)
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| Name | Affiliation | Role |
|---|---|---|
| G. André Ng | University of Leicester | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hull and East Yorkshire Hospitals NHS Trust | Cottingham | United Kingdom | ||||
| The Dudley Group NHS Foundation Trust |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34980634 | Derived | 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. |
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| Dudley |
| United Kingdom |
| Leeds Teaching Hospitals NHS Trust | Leeds | United Kingdom |
| University Hospitals of Leicester NHS Trust | Leicester | United Kingdom |
| Barts Health NHS Trust | London | United Kingdom |
| Imperial college Healthcare NHS Trust | London | United Kingdom |
| Nottingham University Hospitals NHS Trust | Nottingham | United Kingdom |
| Oxford University Hospitals NHS Foundation Trust | Oxford | United Kingdom |
| ID | Term |
|---|---|
| D016757 | Death, Sudden, Cardiac |
| ID | Term |
|---|---|
| D006323 | Heart Arrest |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D003645 | Death, Sudden |
| D003643 | Death |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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