Utilising Lifemap to Investigate Malignant Arrhythmia Therapy (ULTIMATE)
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|ClinicalTrials.gov Identifier: NCT02058771|
Recruitment Status : Recruiting
First Posted : February 10, 2014
Last Update Posted : May 30, 2017
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.
- R2I2 is predictive of ventricular arrhythmia (VA) / SCD in patients with ICM.
- 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.
- 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.
- Serial measurement of R2I2 will produce consistent values.
|Condition or disease|
|Ischemic Cardiomyopathy Sudden Cardiac Death Implantable Defibrillator User Myocardial Infarction Arrhythmias, Cardiac|
|Study Type :||Observational|
|Estimated Enrollment :||60 participants|
|Official Title:||ULTIMATE: Utilising Lifemap to Investigate Malignant Arrhythmia ThErapy|
|Study Start Date :||October 2013|
|Estimated Primary Completion Date :||September 2017|
Patients with ischaemic cardiomyopathy attending for ICD implantation
- Ventricular arrhythmia/Sudden cardiac death [ Time Frame: 18 months ]
- Syncope [ Time Frame: 18 months ]
- All cause mortality [ Time Frame: 18 months ]
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02058771
|Contact: M. Shoaib Siddiqui, MBBS||+44 116 258 firstname.lastname@example.org|
|Contact: Will B Nicolson, MBChBemail@example.com|
|NIHR Leicester Cardiovascular Biomedical Research Unit||Recruiting|
|Leicester, United Kingdom, LE3 9QP|
|Contact: M. Shoaib Siddiqui, MBBS +44 116 258 3643 firstname.lastname@example.org|
|Principal Investigator: G. Andre Ng, MBChB, PhD|
|Sub-Investigator: Will B Nicoloson, MBChB|
|Sub-Investigator: M. Shoaib Siddiqui, MBBS|
|Principal Investigator:||G. Andre Ng, MBChB, PhD||University of Leicester|