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

Sponsor

Maastricht University Medical Center (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT04548804

Collaborator

Jessa Hospital (Other)

270

Enrollment

Locations

Arms

68.1

Anticipated Duration (Months)

135

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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	Diagnostic Test: ECG-Imaging	N/A

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

270 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Both groups (control and diseased) will undergo a body surface potential mapping and a cardiac + low dose CT-scan.Both groups (control and diseased) will undergo a body surface potential mapping and a cardiac + low dose CT-scan.

Masking:

Single (Care Provider)

Masking Description:

The treating physician is not informed about the results of the procedure.

Primary Purpose:

Basic Science

Official Title:

Better Mechanistic Understanding of and Risk Stratification for Ventricular Tachyarrhythmias Through ECGI

Actual Study Start Date :

Jun 10, 2020

Anticipated Primary Completion Date :

Feb 12, 2023

Anticipated Study Completion Date :

Feb 12, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Control Control subjects receiving body-surface potential mapping (BSPM) and CT-scan.	Diagnostic Test: ECG-Imaging A body surface potential mapping and a cardiac + low dose CT-scan
Experimental: Diseased Diseased subjects receiving body-surface potential mapping (BSPM) and CT-scan. Outcome measures from these procedures will be compared to controls.	Diagnostic Test: ECG-Imaging A body surface potential mapping and a cardiac + low dose CT-scan

Arm

Intervention/Treatment

Experimental: Control

Control subjects receiving body-surface potential mapping (BSPM) and CT-scan.

Diagnostic Test: ECG-Imaging

A body surface potential mapping and a cardiac + low dose CT-scan

Experimental: Diseased

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

Diagnostic Test: ECG-Imaging

A body surface potential mapping and a cardiac + low dose CT-scan

Outcome Measures

Primary Outcome Measures

ECG-Imaging outcome: epicardial potentials [3 years]
reconstructed epicardial potentials, represented in mV over time(s).
ECG-Imaging outcome: activation and repolarization maps [3 years]
Activation and repolarization maps. Acivation and repolarization times are determined from the epicardial potentials, expressed in ms. These are shown on a CT-derived heart mesh. The entire activation and repolarization of the epicardium of the heart can be visualized this way.

Secondary Outcome Measures

(Possible) Prognostic risk factors for recurrent ventricular arrhythmias [6 years]
Possible risk factors, found in the clinical data collection, expressed as odds/hazard ratio.
Recurrence of ventricular arrhythmias [6 years]
Documentation over the period of follow-up, if subjects had a recurrence of ventricular arrythmia(s), presented as number of events over a time period.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.