Utilising Lifemap to Investigate Malignant Arrhythmia Therapy

Study Overview
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Brief Summary
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It is universally recognised that current methods for risk stratification of sudden cardiac death (SCD) are limited. A novel SCD risk marker, the Regional Restitution Instability Index (R2I2), measures the degree of heterogeneity in electrical restitution using data obtained from a standard 12 lead ECG acquired during an invasive electrophysiological study. In an ischaemic cardiomyopathy (ICM) cohort of 66 patients, an R2I2 of ≥1.03 identified subjects with a significantly higher risk of ventricular arrhythmia (VA) or death (43%) compared with those with an R2I2 <1.03 (11%) (P=0.004). This study will use non-invasive techniques to acquire electrical restitution data: exercise and pharmacological stress, and will incorporate body surface potential mapping to develop a non-invasive and high-resolution form of R2I2. Suitable patients will be recruited into a prospective, observational study. HYPOTHESES: PRIMARY: R2I2 is predictive of ventricular arrhythmia (VA) / SCD in patients with ICM. The exercise stress protocol will create a dynamic range of heart rates that allows ECG quantification of electrical restitution heterogeneity that correlates with invasive R2I2 and is predictive of VA/SCD. The pharmacological stress protocol will create a dynamic range of heart rates that allows ECG based quantification of electrical restitution heterogeneity that correlates with invasive R2I2 and is predictive of VA/SCD. SECONDARY: A high-resolution electrical map acquired using body surface potential mapping will correlate with R2I2 and these data can be included in the R2I2 calculation to improve its prediction of SCD/VA. Serial measurement of R2I2 will produce consistent values.

Official Title
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ULTIMATE: Utilising Lifemap to Investigate Malignant Arrhythmia ThErapy

Conditions
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Ischemic Cardiomyopathy, Sudden Cardiac Death, Implantable Defibrillator User, Myocardial Infarction, Arrhythmias, Cardiac

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age >18 History of ischaemic cardiomyopathy Exclusion Criteria: Unable to give informed consent <28 days since cardiac surgery or acute coronary syndrome

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ischaemic cardiomyopathy<br>Patients with ischaemic cardiomyopathy attending for ICD implantation | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ventricular arrhythmia/Sudden cardiac death |  | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Syncope |  | 18 months | 
| All cause mortality |  | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Action potential duration restitution, Ventricular arrhythmia, Sudden cardiac death, Body-surface potential mapping, Electrocardiogram