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Utilising Lifemap to Investigate Malignant Arrhythmia Therapy

NCT ID: NCT02058771

Last Updated: 2020-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-10-31

Study Completion Date

2022-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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

Keywords

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Ischaemic cardiomyopathy

Patients with ischaemic cardiomyopathy attending for ICD implantation

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Age \>18
* History of ischaemic cardiomyopathy

Exclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Leicester

OTHER

Sponsor Role collaborator

University Hospitals, Leicester

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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G. Andre Ng, MBChB, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Leicester

Locations

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NIHR Leicester Cardiovascular Biomedical Research Unit

Leicester, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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M. Shoaib Siddiqui, MBBS

Role: CONTACT

Phone: +44 116 258 3643

Email: [email protected]

Will B Nicolson, MBChB

Role: CONTACT

Email: [email protected]

Facility Contacts

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M. Shoaib Siddiqui, MBBS

Role: primary

Other Identifiers

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UHL10824: ULTIMATE

Identifier Type: -

Identifier Source: org_study_id