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Ventricular FibrillationVIGILANCENCT03963271

Noninvasive Electrocardiographic Imaging for Individuals at Risk for Apparently Idiopathic Ventricular Fibrillation.

An observational study of Ventricular Fibrillation and Ventricular Arrythmia, run by Maastricht University Medical Center at 3 sites in Netherlands.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study aims to evaluate the electrophysiological properties of the heart conduction system in patients with unexplained polymorphic ventricular tachycardia (VT) and/or ventricular fibrillation (VF), in patients with specific genetic mutations regarding sudden cardiac death or sudden cardiac arrest, in their family… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
ECG-Imaging
How many people
500 participants
Where
3 sitesNetherlands
Study dates
10 Apr 2019to 10 Apr 2023
How long will I take part?
3 Years
Phase
Observational
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

Study population: patients seen at the outpatient clinic at the department of cardiology or (cardio)genetics, patients admitted to the ward of cardiology or the intensive care unit.

Who may be able to join

  • In order to be eligible to participate in this study, a subject must be ≥ 18 years old and meet one of the following criteria:
  • All unexplained polymorphic VT or VF survivors in whom known structural myocardial, respiratory, metabolic and toxicological causes have been excluded through clinical evaluation", with/without a genetic mutation. NB. If results of a diagnostic tests show minor abnormalities but insufficient for a specific diagnosis, this is no exclusion criterion.
  • Selected family members of these patients*
  • Control subjects with structurally normal hearts with a clinical indication for a cardiac CT scan.
  • All 1st and 2nd degree family members being in contact with the cardiologist/treating physician as part of cascade screening will be contacted as described in chapter 11.2.2.
  • Family members must be in adequate health to be able to travel to the hospital for research purposes.
Show all 10Show fewer
  • 3rd degree family members can also be contacted as described in chapter 11.2.2 if at least one of the following criteria is met:
  • The family member has the same genetic mutation as index patient, or;
  • The family member has demonstrated ventricular arrhythmias, or;
  • The clinician has a very strong suspicion of ventricular arrhythmias in the family member.

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.
  • Subject has an estimated glomerular filtration rate (eGFR) of <30mL/min/1.73m2
  • , using the MDRD calculation
  • Unability to give informed consent.
  • Family members of patients with unexplained polymorphic VT/VF, who have severe cardiac abnormalities and/or disease not related to the symptoms or phenotype of the index patient, and which may have a negative influence on results of ECGI according to local investigators.

Trial locations and contacts

3 sites in 1 country.

Netherlands3 sites

  • Amsterdam University medical Centre, location AMC

    Amsterdam

  • Maastricht Universite Medical Centre

    Maastricht, Nederland

  • University Medical Centre Utrecht

    Utrecht

Other trials in Netherlands

About this study

This study aims to evaluate the electrophysiological properties of the heart conduction system in patients with unexplained polymorphic ventricular tachycardia (VT) and/or ventricular fibrillation (VF), in patients with specific genetic mutations regarding sudden cardiac death or sudden cardiac arrest, in their family members and in a control cohort. The electrophysiological properties will be measured with the relatively new technique ECG-Imaging (ECGI).

Also a National Dutch registry for patients with unexplained polymorphic VT and/or VF and their family members will be created.

By combining the data from the registry and the results of ECGI, The investigators hope to identity risk markers for patients at higher risk for apparently idiopathic ventricular fibrillation, and use these for an adapted flow chart for the 'general'population of patients at risk for unexplained polymorphic VT and/or VF. The investigators aim to be able to identify patients before the first 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 polymorphic VT or idiopathic VF 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 VIGILANCE study:

  1. ECGI will be used to noninvasively characterize the epicardial electrophysiological substrate and triggers of:
  • Patients with unexplained polymorphic VT and VF,
  • Index patients of family cohorts with a specific genetic mutation related to arrhythmogenesis, at high risk for unexplained polymorphic VT and/or VF.
  • Family members,
  • A control cohort. Results will be evaluated for risk stratification.
  1. All unexplained polymorphic VT and/or VF patients and their family members will be asked to participate in a National Dutch registry, and these date will be analysed to determine their prognostic value in terms of arrhythmia risk
Being tested
ECG-Imaging
Keywords
idiopathic ventricular fibrillation, polymorphic ventricular tachycardia, body surface potential mapping, ECG Imaging
Medical subject headings
Ventricular Fibrillation, Death, Sudden, Cardiac, Heart Arrest, Cardiovascular Diseases, Arrhythmias, Cardiac, Genetic Diseases, Inborn, Paroxysmal ventricular fibrillation

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 groups in NCT03963271
Study groupRoleWhat they receive
Patients with unexplained polymorphic VT and/or VF1. Unexplained polymorphic VT and/or VF patients. 2. Patients with VF and the DPP6 risk haplotype, reported by the AUMC team. 3. The Worm population of patients with a SCN5A founder mutation and other conspiring genetic variants at MUMC+
Receives: Diagnostic Test: ECG-Imaging
Family membersFamily members of index patients of group(s) mentioned above
Receives: Diagnostic Test: ECG-Imaging
Control groupControl subjects with structurally normal hearts with an indication for a cardiac CT,
Receives: Diagnostic Test: ECG-Imaging

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ECG-Imaging outcome: epicardial potentials

    reconstructed epicardial potentials, represented in mV over time(s).

    Measured: 3 years

  2. ECG-Imaging outcome: activation and repolarization maps

    Activation and repolarization maps. These are made by measuring acivation and repolarization times from the reconstructed potentials in miliseconds. Then local activation and recovery times are plotted on a CT-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)

  1. (Possible) Prognostic risk factors for recurrent ventricular arrhythmias

    possible risk factors, found in the registry, given as odds/hazard ratio.

    Measured: 3 years

  2. Recurrence of ventricular arrhythmias

    documentation over the period of follow-up, if studysubjects had a recurrence of ventricular arrythmia(s), presented as number of events over a time period.

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 May 2019
  2. Study start10 Apr 2019
  3. Primary completion10 Apr 2023 (estimated)
  4. Study completion10 Apr 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
500 participants (estimated)
Target duration
3 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT03963271
Sponsor's protocol ID
NL67079.068.18
Acronym
VIGILANCE
Status last verified
Jul 2021
First submitted
23 Apr 2019
Last updated
7 Jul 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Ventricular Fibrillation and Ventricular Arrythmia, run by Maastricht University Medical Center at 3 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 10 inclusion and 8 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 7 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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?

On the ClinicalTrials.gov record for NCT03963271.

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 7 Jul 2021.

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