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Status unknownNCT02058771ULTIMATEUpdated Nov 9, 2020

Utilising Lifemap to Investigate Malignant Arrhythmia Therapy

An observational study in Ischemic Cardiomyopathy, Sudden Cardiac Death and Implantable Defibrillator User, sponsored by University Hospitals, Leicester. Status unknown at 1 site in United Kingdom. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-11-09.

Sponsored by University Hospitals, Leicester · Observational

The sponsor has not verified this record recently (last verified Nov 2020), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
60
Ages
18 Years and older
Sex
All
01

Study 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.
02

Conditions studied

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

Keywords

  • Action potential duration restitution
  • Ventricular arrhythmia
  • Sudden cardiac death
  • Body-surface potential mapping
  • Electrocardiogram
03

In context

Myocardial Infarction

2,744 studies on the registry are indexed under Myocardial Infarction; 418 are open to participants now.

This study's planned enrollment of 60 is below the median of 500 across 983 observational studies indexed under Myocardial Infarction.

Browse Myocardial Infarction studies →

Lead sponsor

University Hospitals, Leicester is the lead sponsor of 67 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Patients with ischaemic cardiomyopathy attending for ICD implantation

Inclusion criteria

  • Age >18
  • History of ischaemic cardiomyopathy

Exclusion criteria

Exclusion Criteria:

  • Unable to give informed consent
  • \<28 days since cardiac surgery or acute coronary syndrome
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
60 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Ischaemic cardiomyopathy

    Patients with ischaemic cardiomyopathy attending for ICD implantation

06

What researchers measure

Primary outcomes

  1. Ventricular arrhythmia/Sudden cardiac death

    Time frame: 18 months

Secondary outcomes

  1. Syncope

    Time frame: 18 months

  2. All cause mortality

    Time frame: 18 months

07

Study locations

1 of 1 sites recruiting
  • NIHR Leicester Cardiovascular Biomedical Research Unit
    Leicester, LE3 9QP, United Kingdom
    • M. Shoaib Siddiqui, MBBS · Contact · mss33@le.ac.uk · +44 116 258 3643
    • G. Andre Ng, MBChB, PhD · Principal investigator
    • Will B Nicoloson, MBChB · Sub investigator
    • M. Shoaib Siddiqui, MBBS · Sub investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 9, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02058771
Lead sponsor
University Hospitals, Leicester
Collaborators
University of Leicester
Responsible party
Sponsor
First posted
Feb 10, 2014
Start date
Oct 2013
Primary completion
Nov 2022 (estimated)
Completion
Nov 2022 (estimated)
Last update
Nov 9, 2020

Study contacts

M. Shoaib Siddiqui, MBBS
Contact
mss33@le.ac.uk
+44 116 258 3643
Will B Nicolson, MBChB
Contact
wbn1@le.ac.uk
G. Andre Ng, MBChB, PhD
principal investigator · University of Leicester

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

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