The overall aim of this pilot study is to investigate the development of MRI and CSF markers after CAA-related and HA-related ICH in relation to cognitive decline. The results from this pilot trial will be used to design a larger cohort study to…
ID
Source
Brief title
Condition
- Central nervous system vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main parameters are cognitive decline (according to the Mini Mental State
Examination [MMSE]) at 12 months.
Secondary outcome
Other study parameters are date of birth, sex, medical history,
alcohol/drug/caffeine consumption, smoking, medication, cardiovascular risk
factors, neurological history, BMI, blood pressure and APOE genotype. Blood and
CSF markers will also be analysed, as well as SVD markers on the baseline MRI.
Background summary
Dementia is a major contributor of dependence and disability in the ageing
population and is mainly caused by neurodegenerative and cerebrovascular
disease. Dementia occurs in at least 10% of patients who recover from an
intracerebral hemorrhage (ICH) and has a major impact on post ICH recovery. In
the acute phase of ICH, cognitive impairment may be caused directly by the
hemorrhage damaging the brain parenchyma. In the chronic phase, however,
further cognitive decline is also prevalent.
Cognitive decline after ICH might be caused by the underlying etiology of the
ICH. The most frequent underlying small vessel diseases (SVD) that cause ICH
are cerebral amyloid angiopathy (CAA) and hypertensive arteriopathy (HA). CAA
and HA have their own radiological signatures of SVD markers which allow for in
vivo tracking of disease progression using MRI. Although the initial clinical
presentation these two types of SVD differs - CAA classically presents with a
lobar ICH, whereas HA causes deep ICH - both groups of patients are at risk of
developing dementia. However, it has recently been shown that patients with
lobar ICH develop new onset dementia twice as often as patients with deep ICH.
Whether underlying CAA pathology causes this increase, remains unclear. In
addition, whether ICH accelerates the process of vascular damage and if
cognitive decline can be predicted by certain disease markers is uncertain.
Understanding the underlying mechanisms for cognitive decline after ICH helps
to improve knowledge of prognosis and clinical management of patients who are
recovering from ICH.
Study objective
The overall aim of this pilot study is to investigate the development of MRI
and CSF markers after CAA-related and HA-related ICH in relation to cognitive
decline. The results from this pilot trial will be used to design a larger
cohort study to investigate underlying mechanisms of cognitive decline after
ICH.
Study design
The study design is a prospective cohort study.
Study burden and risks
The risks of MRI are minimal (risk of everyday life), because there are no
consequences to the health of the participant. Contra-indications will be
carefully investigated per subject, burden will be kept at a minimum by using
short protocols. There is no direct benefit for the patients except for more
insight into the underlying pathophysiology of the hemorrhages related to their
disease.
Blood withdrawal and lumbar puncture are routine procedures at the Department
of Neurology. Lumbar puncture will be performed by experienced physicians. We
will use atraumatic spinal needles to reduce the risk of post-lumbar puncture
headache.
Patients will be informed extensively about the potential risks of these
procedures, after which written informed consent will be obtained.
Albinusdreef 2
Leiden 2333ZA
NL
Albinusdreef 2
Leiden 2333ZA
NL
Listed location countries
Age
Inclusion criteria
1. Age >= 55years
2. Ability and willingness to provide written informed consent.
3. Supratentorial ICH with cerebral amyloid angiopathy or hypertension related
arteriopathy as the most likely cause.
Exclusion criteria
1. Age < 55y
2. Unable to provide informed consent.
3. Pre-existing cognitive impairment
4. Contra-indications for 3Tesla MRI.
5. Contraindications for lumbar puncture
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 | NL74864.058.20 |