Noninvasive Electrocardiographic Imaging for Individuals at Risk for Apparently Idiopathic Ventri… (NCT03963271) | Clinical Trial Compass
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Noninvasive Electrocardiographic Imaging for Individuals at Risk for Apparently Idiopathic Ventricular Fibrillation.
Netherlands500 participantsStarted 2019-04-10
Plain-language 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 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
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.
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.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
ECG-Imaging outcome: epicardial potentials
Timeframe: 3 years
2
ECG-Imaging outcome: activation and repolarization maps