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Do cerebral microbleeds in asymptomatic individuals reflect early CAA? The Early Detection of Angiopathy (EDAN) Study

Do cerebral microbleeds in asymptomatic individuals reflect early CAA? The Early Detection of Angiopathy (EDAN) Study - Microbleeds and early CAA

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON39566
Enrollment
60
Registered
2013-01-29
Start date
2012-10-01
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cerebral amyloid angiopathy protein accumulation

Interventions

None listed

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1) One or more strictly lobar CMB on previously performed 3D T2*-weighted GRE MRI 2) Ability and willingness to provide written informed consent 3) Age >=60. There is no upper age limit or restriction on race or gender for study participation.

Exclusion criteria

Exclusion criteria: 1) Other definite cause of microbleeds of hemorrhage. Exclusion causes are excessive anticoagulation (INR >3.0), antecedent head trauma or ischemic stroke, CNS tumor, vascular malformation, vasculitis, and blood dyscrasia 2) History of symptomatic hemorrhagic stroke 3) Microbleeds outside lobar or cerebellar brain regions (e.g. basal ganglia, thalamus, brainstem) demonstrated by neuroimaging. The presence of additional cerebellar CMBs is not an exclusion criterium, as CAA can affect the cerebellum. 4) Dementia 5) Contra-indication to MRI (e.g. cranial metallic implant, cardiac pacemaker, severe claustrophobia) 6) Specific contraindications to fMRI, i.e.: a. History of diabetes, ischemic stroke, transient ischemic attack, carotid/intracranial artery stenosis b. Current tobacco use c. Change in antihypertensive medication within the previous three months. d. Seizure within prior year e. Noncorrectable visual impairment

Design outcomes

Primary

MeasureTime frame
1) Measurement of cerebrovascular reactivity to physiological stimuli using fMRI. Previous studies using functional transcranial Doppler (fTCD) to measure the flow velocity in the posterior cerebral artery after visual stimulation, showed a slower and lower peak response to visual stimulation in subjects with CAA compared to normal subjects. The preference of fMRI use over fTCD in this current study is due to less operator dependency and the additional spatial information fMRI provides. 2) PiB- retention measured in regions of interest. PiB, a radioactive ligand, binds to vascular and plaque b-Amyloid. PiB-PET imaging is used to measure the PiB retention and distribution in regions of interests. Previous studies have reported on increased retention of PiB in non-demented subjects with CAA compared to normal controls. Retention was mainly seen in posterior brain regions, reflecting the predilection of CAA for the occipital cortex.

Secondary

MeasureTime frame
The assessment of the following neuropsychological tests will take place after fMRI; CAMCOG, MMSE, Wechsler memory test, trial making test, Stroop test, and word learning test. Though both case and control subjects are neurologically asymptomatic and do not suffer from apparent cognitive impairment on study entry, these cognitive tests are applied in order to detect and adjust for subtle differences when present.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)