Utilising Lifemap to Investigate Malignant Arrhythmia Therapy — ULTIMATE  

Myocardial Infarction Clinical Trial

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

Status Recruiting

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

Related Conditions & MeSH terms

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

• 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
• Start date: October 2013
• Completion date: November 2022