Better Mechanistic Understanding of and Risk Stratification for Ventricular Tachyarrhythmias Through ECGI (BREACH-ECGI)

Maastricht University Medical Centre (MUMC)

Status: Invitation-only

Conditions: Heart Arrest; Ventricular Arrythmia; Cardiac Arrest; Cardiac Death; Polymorphic Ventricular Tachycardia; Sudden Cardiac Death Due to Cardiac Arrhythmia; Ventricular Fibrillation; Cardiac Arrhythmia; Congenital Heart Disease; Sudden Cardiac Arrest; Sudden Cardiac Death; Ventricular Tachycardia

Treatments: Diagnostic Test: ECG-Imaging

Study type: Interventional

Funder types: Other

Identifiers

NCT04548804

METC19-065

NL69831.068.19 (Other Identifier)

300260 (Other Identifier)

Details and patient eligibility

About

This study aims to evaluate the electrophysiological properties of the heart conduction system in patients with (increased risk of) ventricular tachyarrhythmias (VTA) and sudden cardiac arrest, and in a control cohort. The electrophysiological properties will be measured with the relatively new technique ECG-Imaging (ECGI). Moreover, clinical data of subjects will be gathered.

By combining the data from the data gathering and the results of ECGI, the investigators hope to increase mechanistic understanding of and risk stratification for VTAs. The investigators aim to be able to identify patients at risk of an arrhythmic event, and aim for better treatment strategies in the future.

Full description

ECGI combines electrical body-surface mapping with 256 electrodes placed on the thorax with a CT-scan obtaining the anatomy of the heart and torso, hereby able to reconstruct local electrograms, activation and recovery times. In recent research, ECGI provided numerous extra insights into normal cardiac electrophysiology, but also electrophysiological disorders and disease. The results strongly suggest that ECGI can play a pivotal role in further characterizing arrhythmia mechanisms, therefore could do so for VTAs, leading to diagnosis and treatment improvement. Moreover, ECGI seems to have the potential to detect arrhythmogenic substrate in individuals before their first event, offering the possibility to diagnose and treat patients before sudden cardiac arrest occurs.

In the BREACH-ECGI study:

ECGI will be used to noninvasively characterize the epicardial electrophysiological substrate and triggers of:

• Patients with (increased risk of) VTAs
• A control cohort. Results will be evaluated for increased mechanistic understanding and risk stratification.

Moreover, clinical data of subjects will be gathered. These data will be analyzed to determine their prognostic value in terms of arrhythmia risk

Enrollment: 270 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

In order to be eligible to participate in this study, a subject must be ≥ 18 years old, have either a history of VTAs or be at risk of VTAs and have one of the following diagnoses:

• Ischemic cardiomyopathy
• Non-ischemic cardiomyopathy
• Non-structural heart disease
• Congenital heart disease (with a limitation to CCTGA and situs inversus)

Or: a subject must be ≥ 18 years old and have a structurally normal heart with a clinical indication for a cardiac CT.

Exclusion criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study:

• A known strong reaction against electrode attachment or contrast agent.
• Any serious medical condition, which in the opinion of the investigator, may adversely affect the safety and/or effectiveness of the participant or the study.
• Pregnancy, nursing or planning to be pregnant.
• The subject has an estimated glomerular filtration rate (eGFR) of <30mL/min/1.73m2, using the MDRD calculation 14.
• Being unable to give informed consent.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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270 participants in 2 patient groups

Control

Experimental group

Description:

Control subjects receiving body-surface potential mapping (BSPM) and either a CT-scan or a CMR scan

Treatment:

Diagnostic Test: ECG-Imaging

Diseased

Experimental group

Description:

Diseased subjects receiving body-surface potential mapping (BSPM) and either a CT-scan or a CMR scan. Outcome measures from these procedures will be compared to controls.

Treatment:

Diagnostic Test: ECG-Imaging