Cerebral Amyloid AngiopathyCSSNCT05394636
Cerebellar Superficial Siderosis in Cerebral Amyloid Angiopathy
An observational study of Cerebral Amyloid Angiopathy and Siderosis, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
Cerebellar superficial siderosis (SS) has been recently reported to be present in about 10% of both hereditary (n=50) and sporadic (n=46) cerebral amyloid angiopathy (CAA) patients on 3T MRI using susceptibility-weighted imaging (SWI) in the majority of patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebral Amyloid Angiopathy, Siderosis
- What is being tested?
- None, pure observational study
- How many people
- 111 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2022to 31 Dec 2022
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Sporadic probable CAA patients (according to the modified Boston criteria) presenting with acute symptoms related to acute ICH, acute subarachnoid haemorrhage, or cortical SS, between September 2009 and January 2022 in Nîmes University Hospital, France
Who may be able to join
- CAA patients (according to the modified Boston criteria)
- with acute symptoms related to acute ICH, acute subarachnoid haemorrhage, or cortical SS
Who cannot join
- Patients with recent trauma,
- Patients with anticoagulation treatment,
- Patients with pathological blood coagulation tests (activated partial thromboplastin time [aPTT] ratio=patient's aPTT/normal control aPTT] >1.2; or partial thromboplastin time [PTT] <75%) or platelet count (<100 x 109/L)
- Patients with inflammatory CAA
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cerebellar Superficial Siderosis in Cerebral Amyloid Angiopathy on 1.5T T2*-Weighted Imaging
Cerebellar superficial siderosis (SS) has been recently reported to be present in about 10% of both hereditary (n=50) and sporadic (n=46) cerebral amyloid angiopathy (CAA) patients on 3T MRI using susceptibility-weighted imaging (SWI) in the majority of patients. In that study, cerebellar SS was associated with a higher number of supratentorial lobar and superficial cerebellar macrobleeds (although cerebellar SS was not directly located adjacent to these cerebellar macrobleeds). It is unclear if cerebellar SS is caused by in situ leakage of cerebellar leptomeningeal vessels or rather represents hemorrhagic diffusion from cerebellar parenchymal micro/macrobleeds or from supratentorial bleeding sources via the tentorium cerebelli (TC).
- Conditions
- Cerebral Amyloid Angiopathy, Siderosis
- Being tested
- None, pure observational study
- Medical subject headings
- Cerebral Amyloid Angiopathy, Siderosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
None, pure observational studyOther
None, pure observational study
| Study group | Role | What they receive |
|---|---|---|
| cerebral amyloid angiopathy (CAA) | Clinical and 1.5T MRI T2*-weighted imaging characteristics analyses from sporadic probable CAA patients (according to the modified Boston criteria) presenting with acute symptoms related to acute ICH, acute subarachnoid haemorrhage, or cortical SS, Receives: Other: None, pure observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
MRI analyse : presence of cerebellar SS
presence of cerebellar SS (Yes/No)
Measured: baseline
MRI analyse : Location of cerebellar SS
Location of cerebellar SS (vermis, anterior lobe, posterior lobe)
Measured: baseline
MRI analyse : characteristics of cerebellar SS
number of cerebellar sulci involved
Measured: baseline
MRI analyse : characteristics of cerebellar SS
spatial relationship with cerebellar micro- and macrobleeds
Measured: baseline
MRI analyse : Presence of cerebellar macrobleeds
Presence of cerebellar macrobleeds (Yes/No)
Measured: baseline
MRI analyse : Presence of cerebral macrobleeds
Presence of cerebral macrobleeds (Yes/No)
Measured: baseline
MRI analyse : Characteristics of cerebral macrobleeds
spatial relationship of cerebral macrobleeds with the TC [adjacent vs. non-adjacent to TC]
Measured: baseline
MRI analyse : Characteristics of cortical SS
spatial relationship with TC (adjacent vs. non-adjacent to TC)
Measured: baseline
MRI analyse : hemosiderin
presence of hemosiderin deposition along the TC.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2022
- Study start1 Jun 2022
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral Amyloid AngiopathyStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anissa MEGZARI, Study director, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05394636
- Sponsor's protocol ID
- Local/2022/Dr-02
- Acronym
- CSS
- Status last verified
- Dec 2022
- First submitted
- 24 May 2022
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Renard D, Laurent-Chabalier S, Leonte A, Hackius M, Parvu T, Wacongne A, Thouvenot E. Cerebellar Superficial Siderosis in Cerebral Amyloid Angiopathy on 1.5T T2*-Weighted Imaging. Cerebrovasc Dis. 2023;52(6):706-710. doi: 10.1159/000528384. Epub 2023 Mar 6.
PubMed 36878206
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebellar Superficial Siderosis in Cerebral Amyloid Angiopathy on 1.5T T2*-Weighted Imaging
- ClinicalTrials.gov ID
- NCT05394636
- Acronym / sponsor ID
- CSS / Local/2022/Dr-02
- Conditions
- Cerebral Amyloid Angiopathy, Siderosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 27 May 2022 (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.
Cerebellar superficial siderosis (SS) has been recently reported to be present in about 10% of both hereditary (n=50) and sporadic (n=46) cerebral amyloid angiopathy (CAA) patients on 3T MRI using susceptibility-weighted imaging (SWI) in the majority of patients. In that study, cerebellar SS was associated with a higher number of supratentorial lobar and superficial cerebellar macrobleeds (although cerebellar SS was not directly located adjacent to these cerebellar macrobleeds). It is unclear if cerebellar SS is caused by in situ leakage of cerebellar leptomeningeal vessels or rather represents hemorrhagic diffusion from cerebellar parenchymal micro/macrobleeds or from supratentorial bleeding sources via the tentorium cerebelli (TC).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cerebral amyloid angiopathy (CAA) | – | Other: None, pure observational studyClinical and 1.5T MRI T2*-weighted imaging characteristics analyses from sporadic probable CAA patients (according to the modified Boston criteria) presenting with acute symptoms related to acute ICH, acute subarachnoid haemorrhage, or cortical SS, |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Sporadic probable CAA patients (according to the modified Boston criteria) presenting with acute symptoms related to acute ICH, acute subarachnoid haemorrhage, or cortical SS, between September 2009 and January 2022 in Nîmes University Hospital, France
Key inclusion criteria (2 listed)
- CAA patients (according to the modified Boston criteria)
- with acute symptoms related to acute ICH, acute subarachnoid haemorrhage, or cortical SS
Key exclusion criteria (4 listed)
- Patients with recent trauma,
- Patients with anticoagulation treatment,
- Patients with pathological blood coagulation tests (activated partial thromboplastin time [aPTT] ratio=patient's aPTT/normal control aPTT] >1.2; or partial thromboplastin time [PTT] <75%) or platelet count (<100 x 109/L)
- Patients with inflammatory CAA
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 |
|---|---|---|
| None, pure observational studyNone, pure observational study | Other | cerebral amyloid angiopathy (CAA) |
Primary outcome
MRI analyse : presence of cerebellar SS
Time frame: baseline
presence of cerebellar SS (Yes/No)
MRI analyse : Location of cerebellar SS
Time frame: baseline
Location of cerebellar SS (vermis, anterior lobe, posterior lobe)
MRI analyse : characteristics of cerebellar SS
Time frame: baseline
number of cerebellar sulci involved
MRI analyse : characteristics of cerebellar SS
Time frame: baseline
spatial relationship with cerebellar micro- and macrobleeds
MRI analyse : Presence of cerebellar macrobleeds
Time frame: baseline
Presence of cerebellar macrobleeds (Yes/No)
MRI analyse : Presence of cerebral macrobleeds
Time frame: baseline
Presence of cerebral macrobleeds (Yes/No)
MRI analyse : Characteristics of cerebral macrobleeds
Time frame: baseline
spatial relationship of cerebral macrobleeds with the TC [adjacent vs. non-adjacent to TC]
MRI analyse : Characteristics of cortical SS
Time frame: baseline
spatial relationship with TC (adjacent vs. non-adjacent to TC)
MRI analyse : hemosiderin
Time frame: baseline
presence of hemosiderin deposition along the TC.
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 4 Dec 2025.
- Results publication: PubMed 36878206Renard D, Laurent-Chabalier S, Leonte A, Hackius M, Parvu T, Wacongne A, Thouvenot E. Cerebellar Superficial Siderosis in Cerebral Amyloid Angiopathy on 1.5T T2*-Weighted Imaging. Cerebrovasc Dis. 2023;52(6):706-710. doi: 10.1159/000528384. Epub 2023 Mar 6.
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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.
Anissa MEGZARI study director
Centre Hospitalier Universitaire de Nīmes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Amyloid Angiopathy and Siderosis, run by Centre Hospitalier Universitaire de Nīmes at 1 site 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 2 inclusion and 4 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 4 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 1 site 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?
MRI analyse : presence of cerebellar SS (time frame: baseline). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05394636, which also lists 1 linked publication.
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 4 Dec 2025.