To obtain normal values of biventricular volumes, ejection fraction and wall mass using MRI SSFP sequences at 3Tesla.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
normaal waarden hartgrootte en functie bij kinderen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Left ventricular end-diastolic and end-systolic volume, ejection fraction and
wall mass.
Right ventricular end-diastolic and end-systolic volume, ejection fraction and
wall mass.
Secondary outcome
Intra- and interobserver variability of 3T cardiac MRI in children.
Background summary
Cardiac MRI using SSFP sequences at 1.5 Tesla is a validated clinical imaging
tool. It is routinely used in clinical decision making. New developments in MRI
are towards imaging at 3 Tesla. This technique has been validated for
cardiovascular imaging in adults and clinical applications in children are
increasingly used. There is a lack of normal data that are used as reference in
the interpretation in clinical studies in patients with heart disease in the
pedaitric age range.
Study objective
To obtain normal values of biventricular volumes, ejection fraction and wall
mass using MRI SSFP sequences at 3Tesla.
Study design
Prospective observational study in healthy children
Study burden and risks
Cardiavascular MRI at 3Tesla according to common clinical protocols will be
applied. These sequences have been demonstrated to be safe and are not related
to side-effects. Main risk is related to the noise of the scanner during
imaging. Noise will be reduced by external protection of the ears. Some
subjects may find it difficult to lie still in the scanner for 30-40 minutes.
3T cardiac MRI has been associated with increased risk of tissue heating,
considering the higher specific absorption rate compared to 1.5 T cardiac MRI.
This risk will be limited by applying clinically accepted and approved imaging
parameters. The study needs to be performed in children because we aim to
acquire normal values for cardiac size and function in the paediatric age
range. These values have been demonstrated to depend on age, gender and body
size. The relationsship between cardiac size and these parameters is
non-linear. Therefore normal values for the paediatric age range cannot be
obtained by extrapolation form adult values.
dr. Molewaterplein 60
Rotterdam 3015 GJ
NL
dr. Molewaterplein 60
Rotterdam 3015 GJ
NL
Listed location countries
Age
Inclusion criteria
Age 8 - 17 Able to undergo cardiac MRI
Exclusion criteria
Disease affecting the circulatory system Metal implants Unable to follow instructions during cardiac MRI Irregular heart rhythm Claustrophobia
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 | NL42903.078.12 |