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

Primary Purpose

Ventricular Tachycardia, Ventricular Arrythmia, Ventricular Fibrillation

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
ECG-Imaging
Sponsored by
Maastricht University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Ventricular Tachycardia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Jessa Hospital
  • Maastricht University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Control

Diseased

Arm Description

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

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

Outcomes

Primary Outcome Measures

ECG-Imaging outcome: epicardial potentials
reconstructed epicardial potentials, represented in mV over time(s).
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 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
Possible risk factors, found in the clinical data collection, expressed as odds/hazard ratio.
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.

Full Information

First Posted
September 8, 2020
Last Updated
August 26, 2022
Sponsor
Maastricht University Medical Center
Collaborators
Jessa Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04548804
Brief Title
Better Mechanistic Understanding of and Risk Stratification for Ventricular Tachyarrhythmias Through ECGI
Acronym
BREACH-ECGI
Official Title
Better Mechanistic Understanding of and Risk Stratification for Ventricular Tachyarrhythmias Through ECGI
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
June 10, 2020 (Actual)
Primary Completion Date
February 12, 2026 (Anticipated)
Study Completion Date
February 12, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center
Collaborators
Jessa Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Both groups (control and diseased) will undergo a body surface potential mapping and a cardiac + low dose CT-scan.
Masking
Care Provider
Masking Description
The treating physician is not informed about the results of the procedure.
Allocation
Non-Randomized
Enrollment
270 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Experimental
Arm Description
Control subjects receiving body-surface potential mapping (BSPM) and CT-scan.
Arm Title
Diseased
Arm Type
Experimental
Arm Description
Diseased subjects receiving body-surface potential mapping (BSPM) and CT-scan. Outcome measures from these procedures will be compared to controls.
Intervention Type
Diagnostic Test
Intervention Name(s)
ECG-Imaging
Intervention Description
A body surface potential mapping and a cardiac + low dose CT-scan
Primary Outcome Measure Information:
Title
ECG-Imaging outcome: epicardial potentials
Description
reconstructed epicardial potentials, represented in mV over time(s).
Time Frame
3 years
Title
ECG-Imaging outcome: activation and repolarization maps
Description
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.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
(Possible) Prognostic risk factors for recurrent ventricular arrhythmias
Description
Possible risk factors, found in the clinical data collection, expressed as odds/hazard ratio.
Time Frame
6 years
Title
Recurrence of ventricular arrhythmias
Description
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.
Time Frame
6 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Jessa Hospital
City
Hasselt
State/Province
Limburg
ZIP/Postal Code
3500
Country
Netherlands
Facility Name
Maastricht University Medical Center
City
Maastricht
State/Province
Limburg
ZIP/Postal Code
6229hx
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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