Utilising Lifemap to Investigate Malignant Arrhythmia Therapy (ULTIMATE)

ULTIMATE: Utilising Lifemap to Investigate Malignant Arrhythmia ThErapy

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.

Study Overview

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

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

• Study Contact: Name: M. Shoaib Siddiqui, MBBS; Phone Number: +44 116 258 3643; Email: mss33@le.ac.uk
• Study Contact Backup: Name: Will B Nicolson, MBChB; Email: wbn1@le.ac.uk

Study Locations

• United Kingdom
  • Leicester, United Kingdom, LE3 9QP
    • Recruiting
    • NIHR Leicester Cardiovascular Biomedical Research Unit
    • Contact: M. Shoaib Siddiqui, MBBS; Phone Number: +44 116 258 3643; Email: mss33@le.ac.uk
    • Principal Investigator: G. Andre Ng, MBChB, PhD
    • Sub-Investigator: Will B Nicoloson, MBChB
    • Sub-Investigator: M. Shoaib Siddiqui, MBBS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with ischaemic cardiomyopathy attending for ICD implantation

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Ischaemic cardiomyopathy; Patients with ischaemic cardiomyopathy attending for ICD implantation

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Syncope	18 months
All cause mortality	18 months

Collaborators and Investigators

• Sponsor: University Hospitals, Leicester
• Collaborators: University of Leicester
• Investigators: Principal Investigator: G. Andre Ng, MBCHb, PhD, University of Leicester

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Anticipated): November 1, 2022
• Study Completion (Anticipated): November 1, 2022

Study Registration Dates

• First Submitted: February 6, 2014
• First Submitted That Met QC Criteria: February 7, 2014
• First Posted (Estimate): February 10, 2014

Study Record Updates

• Last Update Posted (Actual): November 9, 2020
• Last Update Submitted That Met QC Criteria: November 6, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Action potential duration restitution; Ventricular arrhythmia; Sudden cardiac death; Body-surface potential mapping; Electrocardiogram
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Death, Sudden; Heart Arrest; Myocardial Infarction; Infarction; Death; Arrhythmias, Cardiac; Cardiomyopathies; Death, Sudden, Cardiac
• Other Study ID Numbers: UHL10824: ULTIMATE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No