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

NCT ID: NCT04548804

Last Updated: 2023-10-27

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 270 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-10
• Study Completion Date: 2026-02-12

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

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Control

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

Group Type: EXPERIMENTAL

ECG-Imaging

Intervention Type: DIAGNOSTIC_TEST

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

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.

Group Type: EXPERIMENTAL

ECG-Imaging

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

ECG-Imaging

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

Intervention Type: DIAGNOSTIC_TEST

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jessa Hospital

OTHER

Sponsor Role: collaborator

Maastricht University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Jessa Hospital

Hasselt, Limburg, Netherlands

Maastricht University Medical Center

Maastricht, Limburg, Netherlands

Countries

Netherlands

Other Identifiers

NL69831.068.19

Identifier Type: OTHER

Identifier Source: secondary_id

300260

Identifier Type: OTHER

Identifier Source: secondary_id

METC19-065

Identifier Type: -

Identifier Source: org_study_id