Clinical trial NCT04548804: Better Mechanistic Understanding of and Risk Stratification for Ventricular Tachyarrhythmias Through ECGI
Official title: Better Mechanistic Understanding of and Risk Stratification for Ventricular Tachyarrhythmias Through ECGI
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Ventricular Tachycardia
Ventricular Arrythmia
Ventricular Fibrillation
Polymorphic Ventricular Tachycardia
Sudden Cardiac Death
Sudden Cardiac Arrest
Sudden Cardiac Death Due to Cardiac Arrhythmia
Heart Arrest
Cardiac Death
Cardiac Arrest
Cardiac Arrhythmia
Congenital Heart Disease
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: Jessa Hospital
First posted: 2020-09-16
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Both groups (control and diseased) will undergo a body surface potential mapping and a cardiac + low dose CT-scan.
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed 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

Eligibility criteria: 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.

Primary outcomes:
measure: ECG-Imaging outcome: epicardial potentials
timeFrame: 3 years
measure: ECG-Imaging outcome: activation and repolarization maps
timeFrame: 3 years
Secondary outcomes:
measure: (Possible) Prognostic risk factors for recurrent ventricular arrhythmias
timeFrame: 6 years
measure: Recurrence of ventricular arrhythmias
timeFrame: 6 years
Other outcomes:
Locations:
city: Hasselt
country: Netherlands
facility: Jessa Hospital
state: Limburg
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
state: Limburg
Study officials:
References: