Status:
UNKNOWN
Superficial Siderosis in Patients With Suspected Cerebral Amyloid Angiopathy
Lead Sponsor:
Ludwig-Maximilians - University of Munich
Conditions:
Intracerebral Hemorrhage
Cerebral Amyloid Angiopathy
Eligibility:
All Genders
55+ years
Brief Summary
Aim of the SuSPect-CAA study is to prospectively evaluate the prognostic significance of cortical superficial siderosis in patients with suspected cerebral amyloid angiopathy with a primary focus on f...
Detailed Description
Non-traumatic cortical superficial siderosis (cSS) is a common finding in patients with cerebral amyloid angiopathy (CAA) and can be its sole imaging sign. The clinical features and course as well as ...
Eligibility Criteria
Inclusion
- Inclusion Criteria (study group):
- Fulfillment of the modified Boston criteria for CAA-related hemorrhage with evidence of supratentorial superficial siderosis on MRI
- MR-/CT-/digital subtraction (DS) -angiography without evidence of cerebral aneurysm, arterio-venous malformation (AVM) , AV-fistula or other pathology of relevance (e.g. tumor, hemorrhagic infarction)
- A maximum of two lobar or cerebellar intracranial hemorrhages (ICH) (old or acute)
- Written informed consent by patient or guardian prior to study participation
- Willingness to participate in follow-up
- Inclusion Criteria (control group):
- Fulfillment of the classic Boston criteria for CAA-related hemorrhage
- Absence of superficial siderosis on MRI
- A maximum of two lobar or cerebellar ICHs (old or acute)
- MR-/CT-/DS -angiography without evidence of cerebral aneurysm, AVM, AV-fistula or other pathology of relevance (e.g. tumor, hemorrhagic infarction)
- Written informed consent by patient or guardian prior to study participation
- Willingness to participate in follow-up
- Exclusion Criteria (both groups):
- Severe medical condition with expected life expectancy \<3 years
- More than two lobar or cerebellar ICH (old or acute)
- any intracerebral hemorrhage in the deep grey matter (basal ganglia or thalami) or in the brain stem
- History of head trauma resulting in loss of consciousness or radiologically visible traumatic brain injury (contusions, diffuse axonal damage) in the last 5 years prior to inclusion
- Cerebral aneurysm or history of aneurysmal subarachnoid hemorrhage
- Infratentorial siderosis
- Infratentorial subarachnoid hemorrhage
Exclusion
Key Trial Info
Start Date :
May 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2019
Estimated Enrollment :
302 Patients enrolled
Trial Details
Trial ID
NCT01856699
Start Date
May 1 2013
End Date
May 1 2019
Last Update
August 11 2017
Active Locations (1)
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1
Ludwig-Maximilians-University
Munich, Germany, 81377