Cerebellar Superficial Siderosis in Cerebral Amyloid Angiopathy

Cerebral Amyloid Angiopathy Clinical Trial

— CSS  

Official title:

Cerebellar Superficial Siderosis in Cerebral Amyloid Angiopathy on 1.5T T2*-Weighted Imaging

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05394636
• Other study ID #: Local/2022/Dr-02
• Status: Completed
• Start date: June 1, 2022
• Est. completion date: August 31, 2022

Study information

• Verified date: December 2022
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: August 31, 2022
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Amyloidosis
• Cerebral Amyloid Angiopathy
• Siderosis

Intervention

Other:
• None, pure observational study
None, pure observational study

Locations

Country	Name	City	State
France	CHU de Nîmes	Nîmes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MRI analyse : presence of cerebellar SS	presence of cerebellar SS (Yes/No)	baseline
Primary	MRI analyse : Location of cerebellar SS	Location of cerebellar SS (vermis, anterior lobe, posterior lobe)	baseline
Primary	MRI analyse : characteristics of cerebellar SS	number of cerebellar sulci involved	baseline
Primary	MRI analyse : characteristics of cerebellar SS	spatial relationship with cerebellar micro- and macrobleeds	baseline
Primary	MRI analyse : Presence of cerebellar macrobleeds	Presence of cerebellar macrobleeds (Yes/No)	baseline
Primary	MRI analyse : Presence of cerebral macrobleeds	Presence of cerebral macrobleeds (Yes/No)	baseline
Primary	MRI analyse : Characteristics of cerebral macrobleeds	spatial relationship of cerebral macrobleeds with the TC [adjacent vs. non-adjacent to TC]	baseline
Primary	MRI analyse : Characteristics of cortical SS	spatial relationship with TC (adjacent vs. non-adjacent to TC)	baseline
Primary	MRI analyse : hemosiderin	presence of hemosiderin deposition along the TC.	baseline