sudden cardiac arrest
Conditions
Interventions
None listed
Sponsors
Maastricht Universitair Medisch Centrum +
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The study parameters are reconstructions of epicardial potentials, and electrocardiographic quantitative and qualitative measures based on body-surface potential maps. From these, relevant endpoints can be determined, i.e. *normal/abnormal activation or recovery patterns* and *increased dispersion of repolarization*. | — |
Secondary
| Measure | Time frame |
|---|---|
| As part of standard/routine care, if applicable: o Baseline parameters: year of birth, ethnicity, gender, date and circumstances index event o Patient history: symptoms or medication preceding the ventricular arrhythmias, family history o Physical examination (blood pressure, saturation, body temperature) o ECG parameters o Blood chemistry o Toxicological screening o Echocardiography o Exercise test/ Holter monitoring o CAG/ CTA o MRI o Provocation tests o Electrophysiological study o Genetics o Outcomes o ICD parameters o ICD and pacemaker therapy; appropriate, inappropriate and ICD complications o Specific diseases that emerged during follow-up o Extra diagnostic testing, if performed o Outcome: specific underlying diagnosis revealed during follow-up, death, cause of death | — |
Countries
Belgium, Netherlands
Contacts
Public ContactP.G.A. Volders
Maastricht Universitair Medisch Centrum +
Outcome results
None listed