Superficial Siderosis in Patients With Suspected Cerebral Amyloid Angiopathy (SuSPect-CAA)
Cerebral Amyloid Angiopathy
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Observational Study on the Prognostic Relevance of Supratentorial Superficial Siderosis in Patients With Suspected Cerebral Amyloid Angiopathy|
- Combined rate of stroke and death [ Time Frame: 36 months ] [ Designated as safety issue: No ]All cause mortality and stroke (WHO-definition)
- Rate of intracranial hemorrhage [ Time Frame: 6, 12, 24, 36 months ] [ Designated as safety issue: No ]Rate of any intracranial hemorrhage as assessed by cerebral imaging
- Clinical presentation and course of superficial siderosis [ Time Frame: 0, 6, 12, 24, 36 months ] [ Designated as safety issue: No ]A detailed analysis on the clinical presentation and course of superficial siderosis will be performed (detailed questionnaire, comprehensive neurological examinations, disability scales, neuropsychological tests)
- Imaging findings associated with superficial siderosis [ Time Frame: 0, 6, 12, 24, 36 months ] [ Designated as safety issue: No ]Localization, extent and progression of superficial siderosis will be assessed on MR-imaging. In addition, the prevalence, incidence, localization, number or extent of cerebral microbleeds, white matter disease, and acute ischemic lesions will be determined using follow-up MRI.
- Differential causes of superficial siderosis [ Time Frame: 0, 6, 12, 24, 36 months ] [ Designated as safety issue: No ]At the time of patient screening and follow-up we will systematically evaluate the underlying causes of superficial siderosis and potential differential diagnoses based on the available clinical, laboratory and imaging data, as well as published diagnostic criteria.
Biospecimen Retention: Samples With DNA
|Study Start Date:||May 2013|
|Estimated Study Completion Date:||May 2018|
|Estimated Primary Completion Date:||May 2018 (Final data collection date for primary outcome measure)|
Patients with supratentorial superficial siderosis and possible or probable cerebral amyloid angiopathy meeting the modified Boston criteria.
Patients with possible or probable cerebral amyloid angiopathy meeting the classic Boston criteria but without any supratentorial superficial siderosis.
Non-traumatic supratentorial superficial siderosis (SS) 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 the prognostic significance of SS in CAA patients remain unclear. In a retrospective study we have previously shown that SS might be an important predictor or warning sign for future intracranial hemorrhage. However, prospective data are missing.
The Superficial Siderosis in Patients with suspected Cerebral Amyloid Angiopathy (SuSPect-CAA) study is designed as a prospective observational multi-centre cohort study. Primary objective of the study is to evaluate if SS is a predictor for future stroke and mortality (primary endpoint: combined rate of stroke and death after 36 months). Secondary objectives of the study include 1) to evaluate if SS represents a marker of future intracranial haemorrhage, especially at the site of initial siderosis, 2) to describe the clinical presentation and course of SS, 3) to assess to associated imaging findings, 4) to determine the differential diagnoses of SS.
All subjects presenting to the respective neurological centers (out- or inpatient treatment with neuroimaging) will be screened. The study population will consist of two patient groups: 1) Patients meeting the modified Boston criteria for probable or possible CAA, i. e. patients with SS +/- lobar intracerebral hemorrhage or microbleeds in cortico-subcortical localization and absence of other cause of hemorrhage than CAA will be assigned to the study group. 2) Patients meeting the classic Boston criteria for possible or probable CAA but without any SS will be assigned to the control group. A total of 100 patients per group will be enrolled. Baseline and follow-up assessment at 6, 12, 24, and 36 months will be performed by visits in the respective neurological outpatient clinic including a structured interview and neurological exam, neuropsychological tests, EEG and MRI.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01856699
|Contact: Christian Opherk, MD||+49 89 7095 ext firstname.lastname@example.org|
|Contact: Jennifer Linn, MD||+49 89 7095 ext email@example.com|
|Munich, Germany, 81377|
|Principal Investigator: Christian Opherk, MD|
|Principal Investigator: Jennifer Linn, MD|
|Principal Investigator:||Christian Opherk, MD||Institute for Stroke and Dementia Research, Ludwig-Maximilans-University|
|Principal Investigator:||Jennifer Linn, MD||Department of Neuroradiology, Ludwig-Maximilians-University|
|Study Director:||Martin Dichgans, MD||Institute for Stroke and Dementia Research, Ludwig-Maximilians-University|