Utilising Lifemap to Investigate Malignant Arrhythmia Therapy

Last updated: November 6, 2020
Sponsor: University Hospitals, Leicester
Overall Status: Active - Recruiting

Phase

N/A

Condition

Occlusions

Coronary Artery Disease

Cardiomyopathy

Treatment

N/A

Clinical Study ID

NCT02058771
UHL10824: ULTIMATE
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age >18
  • History of ischaemic cardiomyopathy

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 60
Study Start date:
October 01, 2013
Estimated Completion Date:
November 30, 2022

Connect with a study center

  • NIHR Leicester Cardiovascular Biomedical Research Unit

    Leicester, LE3 9QP
    United Kingdom

    Active - Recruiting

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