Utilising Lifemap to Investigate Malignant Arrhythmia Therapy

Myocardial Infarction Clinical Trial

— ULTIMATE  

Official title:

ULTIMATE: Utilising Lifemap to Investigate Malignant Arrhythmia ThErapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02058771
• Other study ID #: UHL10824: ULTIMATE
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

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

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