Cerebellar Superficial Siderosis in Cerebral Amyloid Angiopathy

Completed

• Conditions: Siderosis; Cerebral Amyloid Angiopathy
• Interventions: Other: None, pure observational study

• Registration Number: NCT05394636
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-24
• Study First Submitted QC: 2022-05-24
• Study First Posted: 2022-05-27
• Study Start: 2022-06-01
• Primary Completion: 2022-08-31
• Study Completion: 2022-08-31
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-05
• Last Update Posted: 2022-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 111

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
cerebral amyloid angiopathy (CAA)	None, pure observational study	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,

Primary Outcome Measures

Name	Time	Method
MRI analyse : presence of cerebellar SS	baseline	presence of cerebellar SS (Yes/No)
MRI analyse : characteristics of cerebellar SS	baseline	spatial relationship with cerebellar micro- and macrobleeds
MRI analyse : Characteristics of cortical SS	baseline	spatial relationship with TC (adjacent vs. non-adjacent to TC)
MRI analyse : hemosiderin	baseline	presence of hemosiderin deposition along the TC.
MRI analyse : Presence of cerebral macrobleeds	baseline	Presence of cerebral macrobleeds (Yes/No)
MRI analyse : Location of cerebellar SS	baseline	Location of cerebellar SS (vermis, anterior lobe, posterior lobe)
MRI analyse : Presence of cerebellar macrobleeds	baseline	Presence of cerebellar macrobleeds (Yes/No)
MRI analyse : Characteristics of cerebral macrobleeds	baseline	spatial relationship of cerebral macrobleeds with the TC \[adjacent vs. non-adjacent to TC\]

Trial Locations

Locations (1)

CHU de Nîmes; 🇫🇷 Nîmes, France