The primary aim of this study is to assess the applicability of RT3DE for the evaluation of left ventricular function in daily clinical practice of a pediatric cardiology service.
ID
Source
Brief title
Condition
- Congenital cardiac disorders
- Cardiac and vascular disorders congenital
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The duration of data acquisition and data analyses, the reproducibility
(intra-observer, inter-observer and test-retest variability), and the
capability of identifying changes in left ventricular ejection fraction. These
parameters will be compared for RT3DE and conventional echocardiography.
Secondary outcome
Not applicable.
Background summary
In children born with congenital heart disease (CHD), decreased ventricular
function is an important predictor for morbidity and mortality. Therefore,
careful monitoring of cardiac function, with the possibility to intervene
therapeutically before heart failure becomes manifest, is essential in children
with CHD. MRI is considered to be the standard for quantification of
ventricular function. However, particularly in the pediatric age group MRI has
important disadvantages like the need for general anaesthesia in order to lay
down still during data-acquisition and the fact that it is not a bedside
imaging technique. Consequently MRI is not practical for routine clinical use.
Bedside measurements of ventricular function can be obtained by M-mode (1D) and
2D-echocardiography (2DE). These measurements are unreliable because they rely
on geometric assumptions that do apply to normal hearts, but often not to
diseased hearts. 3D-Echocardiography (3DE) can overcome these problems, since
the entire left ventricle is imaged, obviating the need for geometric
assumptions. In adults with normal and abnormal hearts, real-time 3DE (RT3DE)
has been shown to be more accurate than 1D/2DE for quantification of
ventricular function and was extensively validated with MRI techniques. The use
of RT3DE for ventricular quantification in children has hardly been
investigated. Only a few small studies in selected pediatric patients have
validated RT3DE measurements of ventricular function with MRI, but none have
tested the clinical applicability of RT3DE for evaluation of ventricular
function in daily practice. The hypothesis is that with the currently
available, dedicated pediatric RT3DE hard- and software, ventricular function
can be assessed in routine practice by RT3DE in pediatric patients with
different kinds of CHD.
Study objective
The primary aim of this study is to assess the applicability of RT3DE for the
evaluation of left ventricular function in daily clinical practice of a
pediatric cardiology service.
Study design
Prospective feasibility study. In addition to the standard 2D echo-protocol,
M-mode, 2D and 3D images will be made in order to measure left ventricular
function. All patients will undergo three echocardiography*s; one before and
twice after intervention. The first two echocardiography*s coincide with
echocardiography*s performed for clinical reasons. Healthy volunteers will
undergo two echocardiography*s, of which the first one will coincide with an
echocardiographic examination performed for diagnostic purposes.
Study burden and risks
This study will be performed in patients under the age of 18, because the
purpose of this study is to evaluate the clinical application of RT3DE in daily
clinical practise of a pediatric cardiology clinic. The echocardiographic
examinations coincide in the majority with echocardiography*s performed for
diagnostic purposes. Echocardiography is not an invasive examination, doesn*t
bring a burden and ultrasound waves have no vulnerable characteristics and
bring therefore no health risks to the participating persons. The burden for
the participating persons will mainly exist from one extra visit to our out
patient clinic and an extra waiting time (10 minutes) on top of the standard
echocardiographic examination.
Postbus 9101
6500 HB Nijmegen
Nederland
Postbus 9101
6500 HB Nijmegen
Nederland
Listed location countries
Age
Inclusion criteria
Patients:
- Age (< 18 years)
- Scheduled for a therapeutic cardiac intervention (surgical ro catheterisation) for one of the following four different diagnostic groups:
1. ventricular septal defects (VSD), n = 20, or
2. left ventricular outflow tract obstruction (LVOTO), n = 20, or
3. atrial septal defects (ASD), n = 20, or
4. right ventricular outflow tract obstruction, n = 20;Controls:
Age (<18 yr), Without cardiac anomalies
Exclusion criteria
Controls: Complains suiting acute illness, hemodynamic unstability
Patients: Complains suiting acute illness, hemodynamic unstability
Design
Recruitment
Medical products/devices used
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 | NL24885.091.08 |