Cerebral Amyloid AngiopathyCORELIANCT03464344
Cortical Superficial Siderosis and Risk of Recurrent Intracerebral Hemorrhage in Cerebral Amyloid Angiopathy.
A study testing neurological, neuropsychological and MRI evaluation in people with Cerebral Amyloid Angiopathy, run by University Hospital, Toulouse at 4 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Cerebral Amyloid Angiopathy
- What is being tested?
- neurological, neuropsychological and MRI evaluation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 4 sitesFrance
- Study dates
- 12 Oct 2018to 11 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
France4 sites
Pellegrin Hospital
Bordeaux
Gui de Chauliac Hospital
Montpellier
Lariboisière Hospital
Paris
CHU Purpan. Hôpital Pierre-Paul Riquet
Toulouse, 31059
About this study
Official title: COrtical Superficial Siderosis and REcurrent Lobar 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.
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.
- Conditions
- Cerebral Amyloid Angiopathy
- Being tested
- neurological, neuropsychological and MRI evaluation
- Keywords
- intracerebral hemorrhage, cerebral amyloid angiopathy, cortical superficial siderosis, Magnetic Resonance Imaging
- Medical subject headings
- Cerebral Amyloid Angiopathy, Cerebral Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neurological, neuropsychological and MRI evaluationOther
neurological, neuropsychological and MRI evaluation
| Study group | Role | What they receive |
|---|---|---|
| Patients with cortical superficial siderosis. | Other | During a systematic follow-up of 24 months, patients will undergo neurological, neuropsychological and MRI evaluation Receives: Other: neurological, neuropsychological and MRI evaluation |
| Patients without cortical superficial siderosis | Other | During a systematic follow-up of 24 months, patients will undergo neurological, neuropsychological and MRI evaluation Receives: Other: neurological, neuropsychological and MRI evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 months
Secondary outcomes (7)
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.
Measured: 12 months
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)
Measured: 12 and 24 months
mortality or dependance at 12 and 24 months
Mortality and dependence defined by a modified Rankin scale >2
Measured: 12 and 24 months
Cognitive decline at 12 and 24 months
moderate or severe vascular cognitive disorders (VCD) according to the VASCOG criteria.
Measured: 12 and 24 months
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
Measured: 12 months
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).
Measured: 12 months
frequency of APOE ε2 and ε4 allele
frequency of both ε2 and ε4 allele on Apolipoprotein E (APOE) genotype at baseline
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2018
- Study start12 Oct 2018
- Primary completion11 Feb 2025
- Study completion11 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Amyloid AngiopathyStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolas RAPOSO, MD, Principal investigator, University Hospital, ToulouseLionel CALVIERE, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03464344
- Sponsor's protocol ID
- RC31/16/8919
- Other IDs
- 2017-A01524-49
- Acronym
- CORELIA
- Status last verified
- Dec 2025
- First submitted
- 7 Mar 2018
- Last updated
- 31 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COrtical Superficial Siderosis and REcurrent Lobar Intracerebral Hemorrhage in Cerebral Amyloid Angiopathy.
- ClinicalTrials.gov ID
- NCT03464344
- Acronym / sponsor ID
- CORELIA / RC31/16/8919
- Conditions
- Cerebral Amyloid Angiopathy
- Keywords
- intracerebral hemorrhage, cerebral amyloid angiopathy, cortical superficial siderosis, Magnetic Resonance Imaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 12 Oct 2018 (actual)
- Primary completion
- 11 Feb 2025 (actual)
- Study completion
- 11 Feb 2025 (actual)
- First posted
- 14 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with cortical superficial siderosis. | Other | Other: neurological, neuropsychological and MRI evaluationDuring a systematic follow-up of 24 months, patients will undergo neurological, neuropsychological and MRI evaluation |
| Patients without cortical superficial siderosis | Other | Other: neurological, neuropsychological and MRI evaluationDuring a systematic follow-up of 24 months, patients will undergo neurological, neuropsychological and MRI evaluation |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| neurological, neuropsychological and MRI evaluationneurological, neuropsychological and MRI evaluation | Other | Patients with cortical superficial siderosis., Patients without cortical superficial siderosis |
Primary outcome
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
7 secondary outcomes
Recurrent symptomatic ICH at 12 months
Time frame: 12 months
Transient Focal Neurological Episodes (TFNE) at 12 and 24 months
Time frame: 12 and 24 months
mortality or dependance at 12 and 24 months
Time frame: 12 and 24 months
Cognitive decline at 12 and 24 months
Time frame: 12 and 24 months
New MRI hemorrhagic lesion at 12 months
Time frame: 12 months
Extent of cortical superficial siderosis at 12 months
Time frame: 12 months
frequency of APOE ε2 and ε4 allele
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2025.
- Individual participant dataSharing planned: No
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Effect of the Mediterranean Diet in Patients Affected by CADASIL and Cerebral Amyloid Angiopathy.
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Active, not recruitingPhase 2
Safety, Tolerability and Efficacy of NPI-001 in Patients With Hereditary Cystatin C Amyloid Angiopathy (HCCAA)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicolas RAPOSO, MD principal investigator
University Hospital, Toulouse
Lionel CALVIERE principal investigator
University Hospital, Toulouse
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing neurological, neuropsychological and MRI evaluation in people with Cerebral Amyloid Angiopathy, run by University Hospital, Toulouse at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrent symptomatic intracerebral hemorrhage at 24 months (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2025.