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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03464344
Acronym
CORELIA
Enrollment
170
Registered
2018-03-14
Start date
2018-10-12
Completion date
2025-02-11
Last updated
2025-12-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Amyloid Angiopathy

Keywords

intracerebral hemorrhage, cerebral amyloid angiopathy, cortical superficial siderosis, Magnetic Resonance Imaging

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.

Interventions

OTHERneurological, neuropsychological and MRI evaluation

neurological, neuropsychological and MRI evaluation

Sponsors

University Hospital, Toulouse
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Recurrent symptomatic intracerebral hemorrhage at 24 months24 monthsRecurrent symptomatic intracerebral haemorrhage is defined as a further intracerebral hemorrhage documented by CT scan or MRI, associated with new neurologic symptoms

Secondary

MeasureTime frameDescription
Transient Focal Neurological Episodes (TFNE) at 12 and 24 months12 and 24 monthsTFNE 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)
mortality or dependance at 12 and 24 months12 and 24 monthsMortality and dependence defined by a modified Rankin scale \>2
Cognitive decline at 12 and 24 months12 and 24 monthsmoderate or severe vascular cognitive disorders (VCD) according to the VASCOG criteria.
Recurrent symptomatic ICH at 12 months12 monthsRecurrent symptomatic intracerebral haemorrhage is defined as a further intracerebral hemorrhage documented by CT scan or MRI, associated with new neurologic symptoms.
Extent of cortical superficial siderosis at 12 months12 monthsExtent 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 allelebaselinefrequency of both ε2 and ε4 allele on Apolipoprotein E (APOE) genotype at baseline
New MRI hemorrhagic lesion at 12 months12 monthsPresence of new symptomatic or asymptomatic hemorrhagic lesion (ICH, microbleeds, convexity subarachnoid hemorrhage) on follow-up MRI at 12 months

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026