Utilising Lifemap to Investigate Malignant Arrhythmia Therapy

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

• Registration Number: NCT02058771
• Lead Sponsor: University Hospitals, Leicester

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2014-02-06
• Study First Submitted QC: 2014-02-07
• Study First Posted: 2014-02-10
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-06
• Last Update Posted: 2020-11-09
• Primary Completion: 2022-11
• Study Completion: 2022-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Age >18
• History of ischaemic cardiomyopathy

Exclusion Criteria

• Unable to give informed consent
• <28 days since cardiac surgery or acute coronary syndrome

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Ventricular arrhythmia/Sudden cardiac death	18 months

Secondary Outcome Measures

Name	Time	Method
All cause mortality	18 months
Syncope	18 months

Trial Locations

Locations (1)

NIHR Leicester Cardiovascular Biomedical Research Unit; 🇬🇧 Leicester, United Kingdom