Ventricular TachycardiaBREACH-ECGINCT04548804
Better Mechanistic Understanding of and Risk Stratification for Ventricular Tachyarrhythmias Through ECGI
A study testing ECG-Imaging in people with Ventricular Tachycardia and Ventricular Arrythmia, run by Maastricht University Medical Center at 2 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventricular Tachycardia, Ventricular Arrythmia, Ventricular Fibrillation
- What is being tested?
- ECG-Imaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 2 sitesNetherlands
- Study dates
- 10 Jun 2020to 12 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Jessa Hospital
Hasselt, Limburg, 3500
Maastricht University Medical Center
Maastricht, Limburg, 6229hx
About this study
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.
Read the 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
- Being tested
- ECG-Imaging
- Medical subject headings
- Tachycardia, Ventricular, Ventricular Fibrillation, Death, Sudden, Cardiac, Heart Arrest, Death, Arrhythmias, Cardiac, Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECG-ImagingDiagnostic test
A body surface potential mapping and a cardiac + low dose CT-scan
| Study group | Role | What they receive |
|---|---|---|
| Control | Experimental | Control subjects receiving body-surface potential mapping (BSPM) and either a CT-scan or a CMR scan Receives: Diagnostic Test: ECG-Imaging |
| Diseased | Experimental | 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. Receives: Diagnostic Test: ECG-Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
ECG-Imaging outcome: epicardial potentials
reconstructed epicardial potentials, represented in mV over time(s).
Measured: 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.
Measured: 3 years
Secondary outcomes (2)
(Possible) Prognostic risk factors for recurrent ventricular arrhythmias
Possible risk factors, found in the clinical data collection, expressed as odds/hazard ratio.
Measured: 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.
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study start10 Jun 2020
- Primary completion12 Feb 2026 (estimated)
- Study completion12 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular TachycardiaStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Both groups (control and diseased) will undergo a body surface potential mapping and a cardiac + low dose CT-scan.
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Jessa Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04548804
- Sponsor's protocol ID
- METC19-065
- Other IDs
- NL69831.068.19, 300260
- Acronym
- BREACH-ECGI
- Status last verified
- Oct 2023
- First submitted
- 8 Sep 2020
- Last updated
- 27 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Better Mechanistic Understanding of and Risk Stratification for Ventricular Tachyarrhythmias Through ECGI
- ClinicalTrials.gov ID
- NCT04548804
- Acronym / sponsor ID
- BREACH-ECGI / METC19-065
- Conditions
- Ventricular Tachycardia, Ventricular Arrythmia, Ventricular Fibrillation, Polymorphic Ventricular Tachycardia, Sudden Cardiac Death, Sudden Cardiac Arrest
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Jessa Hospital
- Study start
- 10 Jun 2020 (actual)
- Primary completion
- 12 Feb 2026 (estimated)
- Study completion
- 12 Feb 2026 (estimated)
- First posted
- 16 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- Both groups (control and diseased) will undergo a body surface potential mapping and a cardiac + low dose CT-scan.
| Arm | Type | Receives |
|---|---|---|
| Control | Experimental | Diagnostic Test: ECG-ImagingControl subjects receiving body-surface potential mapping (BSPM) and either a CT-scan or a CMR scan |
| Diseased | Experimental | Diagnostic Test: ECG-ImagingDiseased 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ECG-ImagingA body surface potential mapping and a cardiac + low dose CT-scan | Diagnostic test | Control, Diseased |
Primary outcome
ECG-Imaging outcome: epicardial potentials
Time frame: 3 years
reconstructed epicardial potentials, represented in mV over time(s).
ECG-Imaging outcome: activation and repolarization maps
Time frame: 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 or CMR-derived heart mesh. The entire activation and repolarization of the epicardium of the heart can be visualized this way.
2 secondary outcomes
(Possible) Prognostic risk factors for recurrent ventricular arrhythmias
Time frame: 6 years
Recurrence of ventricular arrhythmias
Time frame: 6 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ECG-Imaging in people with Ventricular Tachycardia and Ventricular Arrythmia, run by Maastricht University Medical Center at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ECG-Imaging outcome: epicardial potentials (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2023.