The aim of this study is to discover a new set of parameters to define the electropathological substrate by integrating cardiac magnetic resonance imaging (CMR) and non-invasive electrocardiographic imaging (ECGI) characteristics. In the future,…
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study parameters include:
- 3D electrical activation maps using epicardial mapping and ECGI.
- The electrocardiographic characteristics (voltage amplitude, voltage
duration, conduction velocity, fractionation) of the different tissue types
(e.g. normal myocardium and scar).
- The correlation between the electrocardiographic characteristics measured
using epicardial mapping and ECGI.
- 3D myocardial scar maps.
- CMR characteristics of the different tissue types (e.g. normal myocardium and
scar).
- The correlation between the 3D electrical activation maps obtained using ECGI
with the 3D CMR myocardial scar maps.
Secondary outcome
Secondary study parameters include e.g. individual evaluation of deaths and
hospitalizations.
Background summary
Patients with a history of myocardial infarction (MI) are at increased risk of
sudden cardiac death (SCD). An implantable cardiac defibrillator (ICD) is a
device designed for acute treatment of life threatening ventricular
tachyarrhythmias causing SCD.
Current guideline recommendations focused on ICD implantation for the
prevention of infarction related SCD are primarily based on a reduced left
ventricular ejection fraction. However, the majority of SCD cases occur in
patients with preserved or moderately reduced LVEF. In addition, relatively few
patients with a reduced LVEF ever experience a life-threatening arrhythmic
event. Consequently, current approaches for risk stratification for myocardial
infarction related SCD remain insufficient. In addition, inappropriate ICD
therapy (ICD therapy for atrial tachyarrhythmias instead of ventricular
tachyarrhythmias) occurs on a regular basis and is a large burden for patients
with an ICD. It is therefore of importance to improve risk stratification and
consequently patient selection for ICD therapy.
Study objective
The aim of this study is to discover a new set of parameters to define the
electropathological substrate by integrating cardiac magnetic resonance imaging
(CMR) and non-invasive electrocardiographic imaging (ECGI) characteristics. In
the future, these new characteristics may contribute to improve risk
stratification for the occurrence of infarction related SCD and consequently
improve patient selection for ICD implantation.
Study design
This study will consist of a multi-center prognostic, follow-up study which
will be performed at Haga Teaching Hospital and Erasmus Medical Center. A total
of 330 CABG patients will undergo cardiac MRI and ECGI prior to surgery.
Epicardial mapping will be performed during surgery, immediately prior to
commencement to extracorporeal circulation. 3-6 Months after CABG, patients
will undergo a second CMR and ECGI to assess changes in the electrical and
tissue characteristics as a consequence of the CABG. In addition, a total of
300 patients with prior myocardial infarction scheduled for ICD implantation
will undergo cardiac MRI and ECGI prior to implantation. Total study duration
is maximal three years with a minimum follow-up of one year and a maximum
follow-up of three years.
Study burden and risks
An MRI scan is a prerequisite for the BSPM and to asses ICD indications.
Although non-invasive, this diagnostic modality can cause nausea, headache or
general discomfort, especially in subjects suffering from claustrophobia. ECGI
uses 256 or 512-channel ECG recordings. ECG electrodes can cause skin
irritation and allergic reactions. Epicardial mapping will prolong the surgical
procedure by 10 minutes on average. There are no additional risks associated
with the mapping procedures.
Leyweg 275
Den Haag 2545CH
NL
Leyweg 275
Den Haag 2545CH
NL
Listed location countries
Age
Inclusion criteria
CABG group: Patients scheduled for elective coronary artery bypass grafting.
a.Patients without a history of myocardial infarction and ventricular tachyarrhythmias (No-infarct group).
b. Patients with a previous myocardial infarction, but no history of ventricular tachyarrhythmias (No-VT group).
c. Patients with a previous myocardial infarction and a history of ventricular tachyarrhythmias (VT group). ;ICD group: Patients with a prior myocardial infarction, scheduled for ICD implantation.
Exclusion criteria
- Any contraindication for MRI.
- Pregnant women, or women of child bearing potential and who are not on a reliable form of birth control
Design
Recruitment
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL53035.098.15 |