The overall aim of this study is to investigate clinical risk factors and MR markers that affect disease progression to gain more insight in targets for prevention and therapy and to better inform patients on prognosis.
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 microvascular CAA markers on 3T-MRI and 7T-MRI, changes
in CSF, recurrence ICH rate and clinical outcome.
Secondary outcome
Other studyparameters will include: date of birth, gender, medical history,
consumption of alcohol/caffeïne/drugs, smoking, medication use, cardiovascular
risk factors, neurological history, BMI, blood pressure and APOE genotype.
Background summary
Sporadic Cerebral Amyloid Angiopathy (sCAA) is one of the most frequent causes
of intracerebral hemorrhage (ICH) and cognitive decline in the elderly. sCAA is
characterized by the deposition of amyloid-β (Aβ) peptide in the capillaries,
arterioles, and small and medium sized arteries of the cerebral cortex,
leptomeninges and cerebellum, possibly due to impaired cerebral clearance of
amyloid-β with increasing age. The clinical disease course of sCAA varies
widely. Some patients suffer only from one ICH whereas others get multiple
recurrent ICH. Some patients have rapid cognitive decline or frequent headaches
and seizures whereas others have a relatively mild symptomatology. Except for
APOE genotype, it is unknown which factors affect the disease course. With
improving MRI techniques an increasing number of MRI markers have been found.
The clinical relevance of these markers and their development over time is
unclear.
Study objective
The overall aim of this study is to investigate clinical risk factors and MR
markers that affect disease progression to gain more insight in targets for
prevention and therapy and to better inform patients on prognosis.
Study design
The study design is a prospective follow-up study.
Study burden and risks
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. 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.
*
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
Inclusion criteria
1. Age >= 50y
2. Ability and willingness to provide written informed consent
3. Probable CAA based on the Boston criteria 2.0, and no family history of
HCHWA-D, including CAA related inflammation
Healthy controls: age- and sex matched to the sCAA group, no history of
neurological disease and free of substantial memory complaints
Exclusion criteria
1. Contra-indications for 3T/7T MRI as determined by the 7Tesla safety
committee (exclusion for a subpart of the study).
2. Contraindications for lumbar puncture (exclusion for a subpart of the
study).
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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 | NL63256.058.17 |