The main objective in this study is to determine whether there is an effect of acute unloading of the left ventricle on the ECG, in particular the T-wave.
ID
Source
Brief title
Condition
- Cardiac disorders, signs and symptoms NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Change of BSM integral maps of the QRST- and STT-interval
Secondary outcome
Several other variables associated with the T-wave and derivable from the BSM.
These variables include the non-dipolar content of the integral maps, T-wave
amplitude, T-wave duration, T-peak to T-end interval (TpTe), QRS duration,
QT-interval, isochrones in the body surface map, QRS integral map, and
dispersion in these values.
Background summary
The electrocardiogram (ECG) is the most important diagnostic tool in
cardiology, measuring electrical activity in the heart. T-wave abnormalities
are associated with e.g. ischemia, repolarization disorders and arrhythmias
which may lead to sudden cardiac death. The (patho)physiological background of
the T-wave and its alterations however, is not beyond debate. Many studies have
been conducted to examine the exact genesis of the T-wave. Notwithstanding that
multiple factors may affect the morphology of the T-wave, the majority of these
studies are solely focused on the dispersion in repolarization of the action
potential. The heart however, is a contracting and relaxing muscle which
suggests that, beside electrical factors, mechanical factors may be of
importance as well. Examination of the effect of cardiomechanics on the
morphology of the T-wave may contribute to a better understanding of T-wave
genesis and consequently an improvement of the diagnostics of repolarization
disorders and the associated risk for arrhythmias. In order to elucidate the
effect of cardiomechanics on the ECG in the in vivo human heart, we selected a
moment in which an abrupt change in ventricular work load occurs, and
structural remodelling is absent. In the catheterisation lab, acute unloading
of the heart takes place during impella guided percutaneous coronary
interventions. Therefore we selected this moment to make body surface maps
(BSMs; multiple lead ECGs) recordings in order to assess whether any changes
occur, and whether mechanoelectrical feedback plays a role in vivo
Study objective
The main objective in this study is to determine whether there is an effect of
acute unloading of the left ventricle on the ECG, in particular the T-wave.
Study design
Observational
Study burden and risks
The PCI procedure will be extended with 15-20 minutes extra time (10 minutes
for preparation and application of electrodes, plus 5-10 minutes for the BSM
measurements). This includes one extra stepwise increase in pump settings and
one stepwise decrease. This all is not accompanied by extra risks for the
patient. In some cases shaving of the thorax is necessary to obtain good
contact of electrodes with the skin. The electrodes of the BSM system might
cause skin reactions such as irritation and itching. There will be no extra
fluoroscopy time due to measurements. The BSM electrode strips are
radio-translucent and do not influence the PCI procedure.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
Patients undergoing an elective percutaneous coronary intervention (PCI) with a supportive Impella placement.
Exclusion criteria
Unstable rhythm: atrial fibrillation (AF); Frequent occurrence of ventricular or atrial extra systoles (VES, AES); Ventricular tachycardias (VTs).
Design
Recruitment
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 | NL37678.018.12 |