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Utilising Lifemap to Investigate Malignant Arrhythmia Therapy

ULTIMATE: Utilising Lifemap to Investigate Malignant Arrhythmia ThErapy

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02058771
Acronym
ULTIMATE
Enrollment
60
Registered
2014-02-10
Start date
2013-10-31
Completion date
2022-11-30
Last updated
2020-11-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

Interventions

None listed

Sponsors

University of Leicester
CollaboratorOTHER
University Hospitals, Leicester
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Age \>18 * History of ischaemic cardiomyopathy

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Ventricular arrhythmia/Sudden cardiac death18 months

Secondary

MeasureTime frame
Syncope18 months
All cause mortality18 months

Countries

United Kingdom

Contacts

Primary ContactM. Shoaib Siddiqui, MBBS
mss33@le.ac.uk+44 116 258 3643
Backup ContactWill B Nicolson, MBChB
wbn1@le.ac.uk

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026