To study whether CMR analysisdifferences in aortic stiffness and myocardial lipid accumulation between SCT recipients and healthy, age-matched controls
ID
Source
Brief title
Condition
- Leukaemias
- Cardiac disorders, signs and symptoms NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Distensibility and pulse wave velocity after SCT, as assessed by CMR.
.
Secondary outcome
Secondary study parameters/endpoints: Echocardiographic and CMR parameters of
cardiac function, including ejection fraction, global myocardial strain,
myocardial fibrosis and myocardial lipid accumulation after SCT.
Background summary
Rationale: The disease-free survival in children undergoing stem cell
transplantation (SCT) for both malignant and non-malignant diseases has
significantly increased during last decades. Therefore, treatment-related
morbidity and long term health issues have become increasingly important as a
measurement of overall treatment outcome. Cardiovascular pathology is a
recognized side effect of treatment. In current practice, monitoring of
cardiovascular function is restricted to echocardiographic analysis, and no
specific attention is given to vascular wall integrity. CMR is a more sensitive
technology to accurately assess ventricular function and aortic stiffness.
Aortic stiffness, measured by CMR, is a known predictive marker for overall
vascular integrity and atherosclerosis. In this (pilot)study, we will us CMR to
investigate both ventricular function and aortic stiffness in children
undergoing SCT.
Study objective
To study whether CMR analysisdifferences in aortic stiffness and myocardial
lipid accumulation between SCT recipients and healthy, age-matched controls
Study design
prospective observational
Study burden and risks
The burden consists of 1 CMR investigation of one hour, without administration
of contrast agent. In preparation for CMR, 6 hours fasting is required (for
adequate quantification of myocardial lipid accumulation). Prior to CMR,
participants will have the possibility to first experience CMR in a dummy-MRI
setting.
The possible direct benefit may involve more accurate information on the
ventricular function (compared to routine echocardiography. Furthermore,
follow-up schemes may be altered based on the findings of possible aortic
dysfunction.
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
Inclusion criteria
All patients 16-25 yrs of age after a stem cell transplantation < 16yoa
No mental retardation
No contra-indication for MRI examination: pacemaker dependency, claustrofobia.
healthy subjects: based on medical history and physical examination. Drug/medication use.
Exclusion criteria
< 16yrs of age
Mental retardation, Contra-indications for MRI-examination
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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 | NL44973.058.13 |