Trial record 1 of 5 for:    "hereditary cerebral amyloid angiopathy" OR "Cerebral Amyloid Angiopathy" OR "Cerebral Amyloid Angiopathy, Familial"
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Superficial Siderosis in Patients With Suspected Cerebral Amyloid Angiopathy (SuSPect-CAA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Ludwig-Maximilians - University of Munich
Sponsor:
Information provided by (Responsible Party):
Christian Opherk, Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier:
NCT01856699
First received: May 15, 2013
Last updated: NA
Last verified: May 2013
History: No changes posted
  Purpose

Aim of the SuSPect-CAA study is to prospectively evaluate the prognostic significance of supratentorial superficial siderosis in patients with suspected cerebral amyloid angiopathy with a primary focus on future stroke and mortality.


Condition
Intracerebral Hemorrhage
Cerebral Amyloid Angiopathy
Ischemic Stroke

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by Ludwig-Maximilians - University of Munich:

Primary Outcome Measures:
  • Combined rate of stroke and death [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    All cause mortality and stroke (WHO-definition)


Secondary Outcome Measures:
  • 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


Other Outcome Measures:
  • 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

whole blood, serum, plasma, CSF


Estimated Enrollment: 200
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)
Groups/Cohorts
Study Group
Patients with supratentorial superficial siderosis and possible or probable cerebral amyloid angiopathy meeting the modified Boston criteria.
Control Group
Patients with possible or probable cerebral amyloid angiopathy meeting the classic Boston criteria but without any supratentorial superficial siderosis.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

hospital based

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01856699

Contacts
Contact: Christian Opherk, MD +49 89 7095 ext 8315 christian.opherk@med.uni-muenchen.de
Contact: Jennifer Linn, MD +49 89 7095 ext 3261 jennifer.linn@med.uni-muenchen.de

Locations
Germany
Ludwig-Maximilians-University Recruiting
Munich, Germany, 81377
Principal Investigator: Christian Opherk, MD         
Principal Investigator: Jennifer Linn, MD         
Sponsors and Collaborators
Ludwig-Maximilians - University of Munich
Investigators
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
  More Information

No publications provided

Responsible Party: Christian Opherk, Principal Investigator, Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier: NCT01856699     History of Changes
Other Study ID Numbers: SuSPect-CAA
Study First Received: May 15, 2013
Last Updated: May 15, 2013
Health Authority: Germany: Ethics Commission

Keywords provided by Ludwig-Maximilians - University of Munich:
supratentorial superficial siderosis
intracerebral hemorrhage
cerebral amyloid angiopathy

Additional relevant MeSH terms:
Cerebral Amyloid Angiopathy
Hemorrhage
Cerebral Hemorrhage
Siderosis
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Cerebral Arterial Diseases
Intracranial Arterial Diseases
Amyloidosis
Proteostasis Deficiencies
Metabolic Diseases
Pneumoconiosis
Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases
Lung Injury
Occupational Diseases

ClinicalTrials.gov processed this record on September 22, 2014