Superficial Siderosis in Patients With Suspected Cerebral Amyloid Angiopathy

NCT01856699 | Unknown

• 1 other identifier: SuSPect-CAA
• Study Type: observational
• Target: 302
• Locations: 1 country
• Sites: 1

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 future stroke and mortality.

Conditions

Intracerebral Hemorrhage; Cerebral Amyloid Angiopathy; Ischemic Stroke

Keywords

supratentorial superficial siderosis; intracerebral hemorrhage; cerebral amyloid angiopathy

Outcome Measures

Primary Outcomes (1)

• Combined rate of stroke and death

  All cause mortality and stroke (WHO-definition)

  36 months

Secondary Outcomes (1)

• Rate of intracranial hemorrhage

  6, 12, 24, 36 months

Other Outcomes (3)

• Clinical presentation and course of superficial siderosis

  0, 6, 12, 24, 36 months

• Imaging findings associated with superficial siderosis

  0, 6, 12, 24, 36 months

• Differential causes of superficial siderosis

  0, 6, 12, 24, 36 months

Study Arms (2)

Study Group

Patients with cortical 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 cortical superficial siderosis.

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

hospital based

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• Cerebral aneurysm or history of aneurysmal subarachnoid hemorrhage
• Infratentorial siderosis
• Infratentorial subarachnoid hemorrhage

Sponsors & Collaborators

• Ludwig-Maximilians - University of Munich: lead

Study Sites (1)

Ludwig-Maximilians-University

Munich, 81377, Germany

Location

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, serum, plasma, CSF

MeSH Terms

Conditions

Cerebral Hemorrhage; Cerebral Amyloid Angiopathy; Ischemic Stroke

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cerebral Arterial Diseases; Intracranial Arterial Diseases; Amyloidosis; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Stroke

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

• Martin Dichgans, MD

  Institute for Stroke and Dementia Research, Ludwig-Maximilians-University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 15, 2013
• First Posted: May 17, 2013
• Study Start: May 1, 2013
• Primary Completion: December 1, 2018
• Study Completion: May 1, 2019
• Last Updated: August 11, 2017

Record last verified: 2017-08

Locations

DE (1)