Better mechanistic understanding and risk stratification of ventricular arrhythmias through ECGI

Recruiting

• Conditions: sudden cardiac arrest; ventricular arrhythmogenesis; 10007521; 10007510

• Registration Number: NL-OMON52499
• 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: 270

Inclusion Criteria

In order to be eligible to participate in this study, a subject must be >= 18
years old, have a either a history or a 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.

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.
• 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.
• In case of a CT scan: the subject has an estimated glomerular filtration rate
(eGFR) of <30mL/min/1.73m2, using the MDRD calculation 14.
• In case of a CT scan: A known strong reaction against contrast agent.
• In case of an MRI scan: the subject is unsuitable to get an MRI scan (such as
described in ODIN protocols *Voorbereiding klinische patiënten voor MRI
onderzoek* and *Uitvoering van MRI onderzoek bij patiënten met een cardiaal
implanteerbare elektronisch device, waaronder een pacemaker en ICD*):
o Non-MRI-compatible metallic implants (vascular clip, neuro-stimulator,
cochlear implant etc.).
o Non-MRI-compatible pacemaker or implantable cardiac defibrillator (ICD).
o Claustrophobia.
• Being unable to give informed consent.

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<br /><br>based on body-surface potential maps. From these, relevant endpoints can be<br /><br>determined, i.e. *normal/abnormal activation or<br /><br>recovery patterns* and *increased dispersion of repolarization*.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>As part of standard/routine care, if applicable:<br /><br><br /><br>o Baseline parameters: year of birth, ethnicity, gender, date and circumstances<br /><br>index event<br /><br>o Patient history: symptoms or medication preceding the ventricular<br /><br>arrhythmias, family history<br /><br>o Physical examination (blood pressure, saturation, body temperature)<br /><br>o ECG parameters<br /><br>o Blood chemistry<br /><br>o Toxicological screening<br /><br>o Echocardiography<br /><br>o Exercise test/ Holter monitoring<br /><br>o CAG/ CTA<br /><br>o MRI<br /><br>o Provocation tests<br /><br>o Electrophysiological study<br /><br>o Genetics<br /><br>o Outcomes<br /><br>o ICD parameters<br /><br>o ICD and pacemaker therapy; appropriate, inappropriate and ICD complications<br /><br>o Specific diseases that emerged during follow-up<br /><br>o Extra diagnostic testing, if performed<br /><br>o Outcome: specific underlying diagnosis revealed during follow-up, death,<br /><br>cause of death</p><br>