Superficial Siderosis in Patients With Suspected Cerebral Amyloid Angiopathy (SuSPect-CAA)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01856699|
Recruitment Status : Unknown
Verified August 2017 by Christian Opherk, Ludwig-Maximilians - University of Munich.
Recruitment status was: Active, not recruiting
First Posted : May 17, 2013
Last Update Posted : August 11, 2017
|Condition or disease|
|Intracerebral Hemorrhage Cerebral Amyloid Angiopathy Ischemic Stroke|
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 the prognostic significance of cSS in CAA patients remain unclear. In a retrospective study we have previously shown that cSS 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 cSS 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 cSS represents a marker of future intracranial haemorrhage, especially at the site of initial siderosis, 2) to describe the clinical presentation and course of cSS, 3) to assess to associated imaging findings, 4) to determine the differential diagnoses of cSS.
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.
|Study Type :||Observational|
|Actual Enrollment :||302 participants|
|Official Title:||Observational Study on the Prognostic Relevance of Supratentorial Superficial Siderosis in Patients With Suspected Cerebral Amyloid Angiopathy|
|Study Start Date :||May 2013|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||May 2019|
Patients with cortical 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 cortical superficial siderosis.
- Combined rate of stroke and death [ Time Frame: 36 months ]All cause mortality and stroke (WHO-definition)
- Rate of intracranial hemorrhage [ Time Frame: 6, 12, 24, 36 months ]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 ]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 ]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 ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01856699
|Munich, Germany, 81377|
|Principal Investigator:||Frank Wollenweber, MD||Institute for Stroke and Dementia Research, Ludwig-Maximilans-University|
|Principal Investigator:||Jennifer Linn, MD||Department of Neuroradiology, Carl Carus University Dresden|
|Principal Investigator:||Christian Opherk, MD||Institute for Stroke and Dementia Research, Ludwig-Maximilans-University|
|Study Director:||Martin Dichgans, MD||Institute for Stroke and Dementia Research, Ludwig-Maximilians-University|