CompletedNot Applicable

Cerebellar Superficial Siderosis in Cerebral Amyloid Angiopathy

France111 participantsStarted 2022-06-01

Plain-language 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. 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).

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * CAA patients (according to the modified Boston criteria) * with acute symptoms related to acute ICH, acute subarachnoid haemorrhage, or cortical SS Exclusion Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

MRI analyse : presence of cerebellar SS

Timeframe: baseline

MRI analyse : Location of cerebellar SS

Timeframe: baseline

MRI analyse : characteristics of cerebellar SS

Timeframe: baseline

MRI analyse : characteristics of cerebellar SS

Timeframe: baseline

MRI analyse : Presence of cerebellar macrobleeds

Timeframe: baseline

MRI analyse : Presence of cerebral macrobleeds

Timeframe: baseline

MRI analyse : Characteristics of cerebral macrobleeds

Timeframe: baseline

MRI analyse : Characteristics of cortical SS

Trial details

NCT IDNCT05394636

SponsorCentre Hospitalier Universitaire de Nīmes

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-12-31

View on ClinicalTrials.gov More Cerebral Amyloid Angiopathy trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

MRI analyse : presence of cerebellar SS

Timeframe: baseline

MRI analyse : Location of cerebellar SS

Timeframe: baseline

MRI analyse : characteristics of cerebellar SS

Timeframe: baseline

MRI analyse : characteristics of cerebellar SS

Timeframe: baseline

MRI analyse : Presence of cerebellar macrobleeds

Timeframe: baseline

MRI analyse : Presence of cerebral macrobleeds

Timeframe: baseline

MRI analyse : Characteristics of cerebral macrobleeds

Timeframe: baseline

MRI analyse : Characteristics of cortical SS