Clinical trial NCT03464344: Cortical Superficial Siderosis and Risk of Recurrent Intracerebral Hemorrhage in Cerebral Amyloid Angiopathy.
Official title: COrtical Superficial Siderosis and REcurrent Lobar Intracerebral Hemorrhage in Cerebral Amyloid Angiopathy.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cerebral Amyloid Angiopathy
Keywords: intracerebral hemorrhage
cerebral amyloid angiopathy
cortical superficial siderosis
Magnetic Resonance Imaging
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2018-03-14
Enrollment: 170
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Recurrent symptomatic intracerebral hemorrhage at 24 months
timeFrame: 24 months
Secondary outcomes:
measure: Recurrent symptomatic ICH at 12 months
timeFrame: 12 months
measure: Transient Focal Neurological Episodes (TFNE) at 12 and 24 months
timeFrame: 12 and 24 months
measure: mortality or dependance at 12 and 24 months
timeFrame: 12 and 24 months
measure: Cognitive decline at 12 and 24 months
timeFrame: 12 and 24 months
measure: New MRI hemorrhagic lesion at 12 months
timeFrame: 12 months
measure: Extent of cortical superficial siderosis at 12 months
timeFrame: 12 months
measure: frequency of APOE ε2 and ε4 allele
timeFrame: baseline
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Pellegrin Hospital
city: Montpellier
country: France
facility: Gui de Chauliac Hospital
city: Paris
country: France
facility: Lariboisière Hospital
city: Toulouse cedex 9
country: France
facility: CHU Purpan. Hôpital Pierre-Paul Riquet
Study officials:
affiliation: University Hospital, Toulouse
name: Nicolas RAPOSO, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Toulouse
name: Lionel CALVIERE
role: PRINCIPAL_INVESTIGATOR
References: