Cortical Superficial Siderosis and Risk of Recurrent Intracerebral Hemorrhage in Cerebral Amyloid Angiopathy.
- Conditions
- Cerebral Amyloid Angiopathy
- Interventions
- Other: neurological, neuropsychological and MRI evaluation
- Registration Number
- NCT03464344
- Lead Sponsor
- University Hospital, Toulouse
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 170
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Patients with cortical superficial siderosis. neurological, neuropsychological and MRI evaluation During a systematic follow-up of 24 months, patients will undergo neurological, neuropsychological and MRI evaluation Patients without cortical superficial siderosis neurological, neuropsychological and MRI evaluation During a systematic follow-up of 24 months, patients will undergo neurological, neuropsychological and MRI evaluation
- Primary Outcome Measures
Name Time Method Recurrent symptomatic intracerebral hemorrhage at 24 months 24 months Recurrent symptomatic intracerebral haemorrhage is defined as a further intracerebral hemorrhage documented by CT scan or MRI, associated with new neurologic symptoms
- Secondary Outcome Measures
Name Time Method New MRI hemorrhagic lesion at 12 months 12 months Presence of new symptomatic or asymptomatic hemorrhagic lesion (ICH, microbleeds, convexity subarachnoid hemorrhage) on follow-up MRI at 12 months
Recurrent symptomatic ICH at 12 months 12 months Recurrent symptomatic intracerebral haemorrhage is defined as a further intracerebral hemorrhage documented by CT scan or MRI, associated with new neurologic symptoms.
mortality or dependance at 12 and 24 months 12 and 24 months Mortality and dependence defined by a modified Rankin scale \>2
Cognitive decline at 12 and 24 months 12 and 24 months moderate or severe vascular cognitive disorders (VCD) according to the VASCOG criteria.
Transient Focal Neurological Episodes (TFNE) at 12 and 24 months 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)
Extent of cortical superficial siderosis at 12 months 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).
frequency of APOE ε2 and ε4 allele baseline frequency of both ε2 and ε4 allele on Apolipoprotein E (APOE) genotype at baseline
Trial Locations
- Locations (4)
Gui de Chauliac Hospital
🇫🇷Montpellier, France
Pellegrin Hospital
🇫🇷Bordeaux, France
Lariboisière Hospital
🇫🇷Paris, France
CHU Purpan. Hôpital Pierre-Paul Riquet
🇫🇷Toulouse cedex 9, France