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Utilising Lifemap to Investigate Malignant Arrhythmia Therapy — ULTIMATE  

Myocardial Infarction Clinical Trial

Official title:
ULTIMATE: Utilising Lifemap to Investigate Malignant Arrhythmia ThErapy

Clinical Trial Summary

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: 1. R2I2 is predictive of ventricular arrhythmia (VA) / SCD in patients with ICM. 2. 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: 1. 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. 2. Serial measurement of R2I2 will produce consistent values.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02058771
Study type Observational
Source University Hospitals, Leicester
Contact M. Shoaib Siddiqui, MBBS
Phone +44 116 258 3643
Email mss33@le.ac.uk
Status Recruiting
Phase
Start date October 2013
Completion date November 2022
View Details
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