oninvasive electrocardiographic imaging for individuals at risk for apparently idiopathic ventricular fibrillatio

Recruiting

• Conditions: Idiopathic ventricular fibrillation; unexplained sudden cardiac arrest; 10007521; 10027664

• Registration Number: NL-OMON56447
• Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 550

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, as already approved in METC protocol NL32128.068.11 (ABR
number 32128). *All 1st and 2nd degree family members being in contact with the
cardiologist/treating physician as part of cascade screening will be contacted.
Family members must be in adequate health to be able to travel to the hospital
for research purposes. 3rd degree family members in contact with the
cardiologist/treating physician can also be contacted 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.
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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.
- 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 a patients with idiopathic unexplained polymorphic VT/VF ,
who have severe cardiac abnormalities and/or disease not related to the
symptoms or phenotype of the index patients and which may have a negative
influence on results of ECGI according to local investigators.
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Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The study parameters are reconstructions of epicardial potentials, and<br /><br>electrocardiographic quantitative and qualitative measures based on<br /><br>body-surface potential maps. From these, relevant endpoints can be determined,<br /><br>i.e. *normal/abnormal activation or recovery patterns* and *increased<br /><br>dispersion of repolarization*. </p><br>