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

Toulouse University Hospital

Status: Completed

Conditions: Cerebral Amyloid Angiopathy

Treatments: Other: neurological, neuropsychological and MRI evaluation

Study type: Interventional

Funder types: Other

Identifiers

NCT03464344

RC31/16/8919

2017-A01524-49 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 170 patients

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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170 participants in 2 patient groups

Patients with cortical superficial siderosis.

Other group

Description:

During a systematic follow-up of 24 months, patients will undergo neurological, neuropsychological and MRI evaluation

Treatment:

Other: neurological, neuropsychological and MRI evaluation

Patients without cortical superficial siderosis

Other group

Description:

During a systematic follow-up of 24 months, patients will undergo neurological, neuropsychological and MRI evaluation

Treatment:

Other: neurological, neuropsychological and MRI evaluation