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NCT Number: NCT03464344

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

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.

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Key information

Conditions

Cerebral Amyloid Angiopathy Amyloidosis Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebral Arterial Diseases Cerebral Hemorrhage Cerebrovascular Disorders Hemorrhage Intracranial Arterial Diseases Intracranial Hemorrhages Metabolic Diseases Nervous System Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Proteostasis Deficiencies Vascular Diseases

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pellegrin Hospital, Bordeaux, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

neurological, neuropsychological and MRI evaluation

Other

neurological, neuropsychological and MRI evaluation

Primary outcomes

  1. Recurrent symptomatic intracerebral hemorrhage at 24 months

    Time frame: 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 outcomes

  1. Recurrent symptomatic ICH at 12 months

    Time frame: 12 months

    Recurrent symptomatic intracerebral haemorrhage is defined as a further intracerebral hemorrhage documented by CT scan or MRI, associated with new neurologic symptoms.

  2. Transient Focal Neurological Episodes (TFNE) at 12 and 24 months

    Time frame: 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)

  3. mortality or dependance at 12 and 24 months

    Time frame: 12 and 24 months

    Mortality and dependence defined by a modified Rankin scale >2

  4. Cognitive decline at 12 and 24 months

    Time frame: 12 and 24 months

    moderate or severe vascular cognitive disorders (VCD) according to the VASCOG criteria.

  5. New MRI hemorrhagic lesion at 12 months

    Time frame: 12 months

    Presence of new symptomatic or asymptomatic hemorrhagic lesion (ICH, microbleeds, convexity subarachnoid hemorrhage) on follow-up MRI at 12 months

  6. Extent of cortical superficial siderosis at 12 months

    Time frame: 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).

  7. frequency of APOE ε2 and ε4 allele

    Time frame: baseline

    frequency of both ε2 and ε4 allele on Apolipoprotein E (APOE) genotype at baseline

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

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

Acronym: CORELIA

Important dates

Study start
2018
Primary completion
2025
Study completion
2025
First posted
Mar 14, 2018
Registry last updated
Dec 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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