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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Ventricular Fibrillation; Heart Arrest; Ventricular Tachycardia; Cardiac Arrest; Congenital Heart Disease; Ventricular Arrythmia; Polymorphic Ventricular Tachycardia; Sudden Cardiac Death; Cardiac Arrhythmia; Cardiac Death; Sudden Cardiac Death Due to Cardiac Arrhythmia; Sudden Cardiac Arrest
• Intervention / Treatment: Diagnostic test: ECG-Imaging

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 Type: Interventional
• Enrollment (Estimated): 270
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Limburg
    • Hasselt, Limburg, Netherlands, 3500
      • Jessa Hospital
    • Maastricht, Limburg, Netherlands, 6229HX
      • Maastricht University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Control; Control subjects receiving body-surface potential mapping (BSPM) and either a CT-scan or a CMR 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 either a CT-scan or a CMR 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
(Possible) Prognostic risk factors for recurrent ventricular arrhythmias	Possible risk factors, found in the clinical data collection, expressed as odds/hazard ratio.	6 years
Recurrence of ventricular arrhythmias	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.	6 years

Collaborators and Investigators

• Sponsor: Maastricht University Medical Center
• Collaborators: Jessa Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2020
• Primary Completion (Estimated): February 12, 2026
• Study Completion (Estimated): February 12, 2026

Study Registration Dates

• First Submitted: September 8, 2020
• First Submitted That Met QC Criteria: September 8, 2020
• First Posted (Actual): September 16, 2020

Study Record Updates

• Last Update Posted (Actual): October 27, 2023
• Last Update Submitted That Met QC Criteria: October 26, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Congenital Abnormalities; Death, Sudden; Cardiac Conduction System Disease; Cardiovascular Abnormalities; Death; Arrhythmias, Cardiac; Heart Arrest; Ventricular Fibrillation; Tachycardia; Tachycardia, Ventricular; Heart Defects, Congenital; Death, Sudden, Cardiac
• Other Study ID Numbers: METC19-065; NL69831.068.19 (Other Identifier: Toetsingonline); 300260 (Other Identifier: Raad van Bestuur)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No