ClinicalTrials.gg
CompletedNCT03464344CORELIAUpdated Dec 31, 2025

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

An interventional study of neurological, neuropsychological and MRI evaluation in Cerebral Amyloid Angiopathy, sponsored by University Hospital, Toulouse. Completed at 4 sites in France. Open to participants aged 55 Years and older. Per ClinicalTrials.gov, last updated 2025-12-31.

Sponsored by University Hospital, Toulouse · Not applicable, Interventional, and Other

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Phase
Not applicable
Study type
Interventional
Enrollment
170
Allocation
Non-randomized
Ages
55 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 10 studies in Cerebral Amyloid Angiopathy with a site in France — none open to participants now, none under way, none of them phase 3. Cerebral Amyloid Angiopathy · France.

Started
2018
the only one that year
No phase
3 of 10
none open now
Registered
4th of 10
by date
Lead sponsor
2 of 10
University Hospital, Toulouse

Among the 10 studies in Cerebral Amyloid Angiopathy with a site in France, this one is the only one that started in 2018, is one of 3 with no phase, and was the 4th registered.

Cerebral Amyloid Angiopathy

37 studies on the registry are indexed under Cerebral Amyloid Angiopathy; 8 are open to participants now.

Browse Cerebral Amyloid Angiopathy studies →

Open to participants now

None of the 10 studies in Cerebral Amyloid Angiopathy with a site in France is open now. The open studies under Cerebral Amyloid Angiopathy, anywhere →

Who these studies take

Of the 7 Cerebral Amyloid Angiopathy studies recruiting now, 6 set no upper age limit and none stop at 75 or younger; 1 takes children under 18; none take healthy volunteers.

This study: 55 Years and older · all sexes · no healthy volunteers.

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Download CSVNarrow it in search →With an account: the 10 studies in Cerebral Amyloid Angiopathy with a site in France as a file.
02

Study 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.

Read the 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.

03

Conditions studied

  • Cerebral Amyloid Angiopathy

Keywords

  • intracerebral hemorrhage
  • cerebral amyloid angiopathy
  • cortical superficial siderosis
  • Magnetic Resonance Imaging
04

Who can participate

Ages eligible
55 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Secondary brain hemorrhage : vascular malformation (arteriovenous malformation, aneurysm, cavernous); cerebral veinous thrombosis; brain tumor; coagulopathy; vasculitis; hemorrhagic infarction,
  • Infratentorial siderosis
  • to MRI
  • Neurosurgical intervention before inclusion,
  • Progressive neoplasm
  • Patient without affiliation to the french social security
  • Patient under guardianship
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
170 participants (actual)

Study arms

  • Other
    Patients with cortical superficial siderosis.

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

    Other: neurological, neuropsychological and MRI evaluation

  • Other
    Patients without cortical superficial siderosis

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

    Other: neurological, neuropsychological and MRI evaluation

Interventions

  • Otherneurological, neuropsychological and MRI evaluation

    neurological, neuropsychological and MRI evaluation

06

What researchers measure

Primary outcomes

  1. Recurrent symptomatic intracerebral hemorrhage at 24 months

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

    Time frame: 24 months

Secondary outcomes

  1. Recurrent symptomatic ICH at 12 months

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

    Time frame: 12 months

  2. Transient Focal Neurological Episodes (TFNE) at 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)

    Time frame: 12 and 24 months

  3. mortality or dependance at 12 and 24 months

    Mortality and dependence defined by a modified Rankin scale \>2

    Time frame: 12 and 24 months

  4. Cognitive decline at 12 and 24 months

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

    Time frame: 12 and 24 months

  5. New MRI hemorrhagic lesion at 12 months

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

    Time frame: 12 months

  6. Extent of cortical superficial siderosis at 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).

    Time frame: 12 months

  7. frequency of APOE ε2 and ε4 allele

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

    Time frame: baseline

07

Study locations

4 sites
  • Pellegrin Hospital
    Bordeaux, France
  • Gui de Chauliac Hospital
    Montpellier, France
  • Lariboisière Hospital
    Paris, France
  • CHU Purpan. Hôpital Pierre-Paul Riquet
    Toulouse, 31059, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Oct 2018 to primary completion in Feb 2025, 75 months.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 7, 2018
First posted
Mar 14, 2018
StartActual
Oct 12, 2018
Primary completionActual
Feb 11, 2025
CompletionActual
Feb 11, 2025
Last update
Dec 31, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 31, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03464344
Responsible party
Sponsor
First posted
Mar 14, 2018
Start date
Oct 12, 2018
Primary completion
Feb 11, 2025
Completion
Feb 11, 2025
Last update
Dec 31, 2025

Study contacts

Nicolas RAPOSO, MD
principal investigator · University Hospital, Toulouse
Lionel CALVIERE
principal investigator · University Hospital, Toulouse

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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