The primary objective is to evaluate the presence of brain damage (defined by white matter lesions (WMLs) or cerebral atrophy or deviations at neuropsychological examination (NPE)) among adults with tetralogy of Fallot (TOF). The secondary objective…
ID
Source
Brief title
Condition
- Cardiac and vascular disorders congenital
- Structural brain disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main endpoints are findings from radiological (MRI) and neuropsychological
examination.
Secondary outcome
Educational levels, (un)employment, presence of work related problems, scores
from the WAI-1 question.
Background summary
Rationale: Patients with congenital heart disease (CHD) are at increased risk
for neurological damage through many pathophysiological ways, especially those
with cyanotic defects. Even mild but especially more severe defects, are also
associated with more unemployment and lower educational levels. We wonder
whether this is due to cognitive impairment and if so, if this is due to
structural brain damage or social factors. Little about this in adults is
known.
Study objective
The primary objective is to evaluate the presence of brain damage (defined by
white matter lesions (WMLs) or cerebral atrophy or deviations at
neuropsychological examination (NPE)) among adults with tetralogy of Fallot
(TOF). The secondary objective is to relate these findings to educational
levels and the presence or absence from unemployment or work related problems.
Study design
This study has a singlecentre, prospective observational cohort study design.
Study burden and risks
No new interventions are involved in this study. Participants will undergo a
planned cardiac MRI scan to which a MRI of the brain will be added. There is no
need for the administration of contrast agents. Radiation exposure is not
applicable. Additionally a short questionnaire, abbreviated NPE and laboratory
test will take place.
The study has a low but potential risk of an unexpected finding on the MRI-scan
of the brain and of experiencing the NPE as burdensome. The additional burden
for the patients mainly consists of the time needed for the investigations,
which is estimated at an additional three hours.
Catharijnesingel 52
Utrecht 3511 GC
NL
Catharijnesingel 52
Utrecht 3511 GC
NL
Listed location countries
Age
Inclusion criteria
- adult age
- known with tetralogy of Fallot (TOF)
- being willing and able to participate (informed consent)
Exclusion criteria
- any mental retardation syndrome that is evidently caused by another cause than the CHD (for example a chromosomal disorder)
- contra-indications for MRI (claustrophobia, inability to lie flat during a minimum of 30 minutes, presence of any magnetisable metal in the body)
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 | NL41568.018.12 |