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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02058771
Other study ID # UHL10824: ULTIMATE
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 2013
Est. completion date November 2022

Study information

Verified date November 2020
Source University Hospitals, Leicester
Contact M. Shoaib Siddiqui, MBBS
Phone +44 116 258 3643
Email mss33@le.ac.uk
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date November 2022
Est. primary completion date November 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Locations

Country Name City State
United Kingdom NIHR Leicester Cardiovascular Biomedical Research Unit Leicester

Sponsors (2)

Lead Sponsor Collaborator
University Hospitals, Leicester University of Leicester

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Ventricular arrhythmia/Sudden cardiac death 18 months
Secondary Syncope 18 months
Secondary All cause mortality 18 months
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