Clinical trial NCT02058771: Utilising Lifemap to Investigate Malignant Arrhythmia Therapy
Official title: ULTIMATE: Utilising Lifemap to Investigate Malignant Arrhythmia ThErapy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: 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
Lead sponsor: University Hospitals, Leicester
Sponsor class: OTHER
Collaborators: name: University of Leicester
First posted: 2014-02-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with ischaemic cardiomyopathy attending for ICD implantation

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.


Eligibility criteria: Inclusion Criteria:

* Age \>18
* History of ischaemic cardiomyopathy

Exclusion Criteria:

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

Primary outcomes:
measure: Ventricular arrhythmia/Sudden cardiac death
timeFrame: 18 months
Secondary outcomes:
measure: Syncope
timeFrame: 18 months
measure: All cause mortality
timeFrame: 18 months
Other outcomes:
Locations:
city: Leicester
country: United Kingdom
facility: NIHR Leicester Cardiovascular Biomedical Research Unit
Study officials:
affiliation: University of Leicester
name: G. Andre Ng, MBChB, PhD
role: PRINCIPAL_INVESTIGATOR
References: