Cortical Superficial Siderosis and Risk of Recurrent Intracerebral Hemorrhage in Cerebral Amyloid Angiopathy.

Study Overview
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Brief Summary
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Cerebral amyloid angiopathy (CAA) is a major cause of lobar intracerebral hemorrhage (ICH) in the elderly with high risk of recurrence. The investigators aim to determine the relationship between cortical superficial siderosis (cSS), a MRI hemorrhagic marker of CAA and the risk of symptomatic ICH recurrence in a multicentric prospective cohort of patients with acute lobar ICH related to CAA. The investigators hypothesize that patients with cSS have an increased risk of recurrent symptomatic ICH relative to those without cSS.

Detailed Description
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Patients with acute lobar ICH fulfilling the Boston criteria for probable or possible CAA will be enrolled within 30 days after ICH onset. Brain MRI performed at baseline will be analyzed blinded to clinical data. Patients with presence of cSS will be compared with those without cSS. During a systematic follow-up of 24 months, patients will undergo neurological, neuropsychological and MRI evaluation. The investigators will compare the rate of recurrent symptomatic ICH at 24 months in patients with vs. without cSS.

Official Title
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COrtical Superficial Siderosis and REcurrent Lobar Intracerebral Hemorrhage in Cerebral Amyloid Angiopathy.

Conditions
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Cerebral Amyloid Angiopathy

Intervention / Treatment
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* Other: neurological, neuropsychological and MRI evaluation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Lobar ICH within 30 days after onset Available brain MRI sequences of adequate quality including fluid-attenuated inversion recovery (FLAIR) and T2*-weighted gradient-recalled echo (T2*-GRE) sequences. Modified Boston criteria for probable or possible CAA Age ≥ 55 years Written consent Exclusion Criteria: Secondary brain hemorrhage : vascular malformation (arteriovenous malformation, aneurysm, cavernous); cerebral veinous thrombosis; brain tumor; coagulopathy; vasculitis; hemorrhagic infarction, Infratentorial siderosis Contraindications to MRI Neurosurgical intervention before inclusion, Progressive neoplasm Patient without affiliation to the french social security Patient under guardianship

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Patients with cortical superficial siderosis.<br>During a systematic follow-up of 24 months, patients will undergo neurological, neuropsychological and MRI evaluation | Other: neurological, neuropsychological and MRI evaluation<br>* neurological, neuropsychological and MRI evaluation<br>|
| Other: Patients without cortical superficial siderosis<br>During a systematic follow-up of 24 months, patients will undergo neurological, neuropsychological and MRI evaluation | Other: neurological, neuropsychological and MRI evaluation<br>* neurological, neuropsychological and MRI evaluation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrent symptomatic intracerebral hemorrhage at 24 months | Recurrent symptomatic intracerebral haemorrhage is defined as a further intracerebral hemorrhage documented by CT scan or MRI, associated with new neurologic symptoms | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrent symptomatic ICH at 12 months | Recurrent symptomatic intracerebral haemorrhage is defined as a further intracerebral hemorrhage documented by CT scan or MRI, associated with new neurologic symptoms. | 12 months | 
| Transient Focal Neurological Episodes (TFNE) at 12 and 24 months | TFNE was defined as transient (≤24 hours), with fully resolving, focal neurological symptoms that had no known alternative explanation other than CAA (e.g., structural brain lesion, atrial fibrillation, extracranial, or intracranial stenosis) | 12 and 24 months | 
| mortality or dependance at 12 and 24 months | Mortality and dependence defined by a modified Rankin scale >2 | 12 and 24 months | 
| Cognitive decline at 12 and 24 months | moderate or severe vascular cognitive disorders (VCD) according to the VASCOG criteria. | 12 and 24 months | 
| New MRI hemorrhagic lesion at 12 months | Presence of new symptomatic or asymptomatic hemorrhagic lesion (ICH, microbleeds, convexity subarachnoid hemorrhage) on follow-up MRI at 12 months | 12 months | 
| Extent of cortical superficial siderosis at 12 months | Extent of cSS is assessed on follow up MRI at 12 months according to the current guidelines: 0: no cSS; 1: focal cSS (restricted to ≤3 sulci); 2: disseminated cSS (≥4 sulci). | 12 months | 
| frequency of APOE ε2 and ε4 allele | frequency of both ε2 and ε4 allele on Apolipoprotein E (APOE) genotype at baseline | baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intracerebral hemorrhage, cerebral amyloid angiopathy, cortical superficial siderosis, Magnetic Resonance Imaging