1. To evaluate the clinical usefulness of STIC with post-process rendering capability. Our goal is to investigate whether STIC gives more accurate information about a suspected cardiac anomaly, compared to conventional 2D ultracardiography.2. To…
ID
Source
Brief title
Part II congenital heart abnormalities
Condition
- Congenital cardiac disorders
- Cardiac and vascular disorders congenital
- Foetal complications
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To compare conventional 2D echocardiography with STIC, when cardiac anomalies
are suspected, to investigate the clinical usefullness of STIC.
Secondary outcome
To investigate the possibility of "tele-medicine" in the future.
Background summary
Congenital heart defects (CHD) are the most common congenital anatomic
maformations, affecting approximately 0,6-5% of live born children. In neonates
with congenital malformations, CHD cause 20% of neonatal deaths and up to 50%
of infant mortality and morbidity in the first year of life. Nevertheless,
cardiac anomalies are the most commonly overlooked lesions. Prenatal diagnosis
of congenital heart malformations is associated with improvement in neonatal
morbidity and mortality.
Real-time 2D ultrasound, the routinely-used tool for fetal echocardiography, is
a sophisticated diagnostic method but it remains limited. The technique is very
operator-dependent and is commonly time consuming.
Spatio-Temporal image correlation (STIC) is the latest approach to clinical
assessment of the fetal heart. STIC is an automated volume acquisition in which
the array inside the transducer housing performs a slow, single sweep,
recording one single threedimensional volume dataset. Echocardiography using
STIC technology may have the potential to make the echoscopic screening for
congenital heart malformations less operator-dependent and may increase the
prenatal detection rate of congenital heart defects.
No studies however have systematically investigated the feasibility and
capability of STIC to perform a full cardiac examination when cardiac anomalies
are suspected. Another field that is not yet has been studied is the
possibility of "tele-medicine" via internet.
Study objective
1. To evaluate the clinical usefulness of STIC with post-process rendering
capability. Our goal is to investigate whether STIC gives more accurate
information about a suspected cardiac anomaly, compared to conventional 2D
ultracardiography.
2. To investigate whtether STIC allows "tele-medicine".
Study design
During the ultrasound investigation, when cardiac anomalies are suspected,
multiple STIC volume datasets are acquired from fetuses with a gestational age
ranging from 12 to 40 weeks. Before acquisition of a STIC volume, a full 2D
echocardiographic examination is performed by one experienced sonographer.
During the 2D echocardiographic examination a listed number of anatomical and
morphological structures are scored, based on their visibility. The STIC
volumes are examined off-line, using the same check list. The scores from both
tests are calculated and compared. Eventually, the postmortem/postnatal
diagnosis acts as the gold standard.
The STIC volumes will be scored by three different experts at a remote site,
with a lot of experience in fetal echocardiography. All the differents experts
will make a diagnosis, based on the STIC volumes. The results will be compared.
Thereby, the possibility of "tele-medicine" in the future will be investigated.
Intervention
Spatio-Temporal Image Correlation (STIC)
Study burden and risks
Ultrasound has been used in obstetrics since the 1970's. There are no proven
adverse effects of ultrasound investigations on foetus or mother.
Boelelaan 1117
1081 HV Amsterdam
NL
Boelelaan 1117
1081 HV Amsterdam
NL
Listed location countries
Age
Inclusion criteria
suspicion of a fetal congenital heart disease
fetuses with known chromosomal abnormalities
Exclusion criteria
fetal cardiac rhythm disturbances
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 | NL24619.029.08 |