CSS: Cerebellar Superficial Siderosis in Cerebral Amyloid Angiopathy

• Sponsor: Centre Hospitalier Universitaire de Nīmes (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05394636
• Collaborator: (none)
• Enrollment: 111
• Location: 1
• Anticipated Duration (Months): 12
• Patients Per Site Per Month: 9.3

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Cerebral Amyloid Angiopathy; Siderosis	Other: None, pure observational study

Study Design

• Study Type: Observational
• Anticipated Enrollment: 111 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Cerebellar Superficial Siderosis in Cerebral Amyloid Angiopathy on 1.5T T2*-Weighted Imaging
• Actual Study Start Date: Jun 1, 2022
• Anticipated Primary Completion Date: Jun 1, 2023
• Anticipated Study Completion Date: Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
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,	Other: None, pure observational study; None, pure observational study

Outcome Measures

Primary Outcome Measures

1. MRI analyse : presence of cerebellar SS [baseline]

   presence of cerebellar SS (Yes/No)

2. MRI analyse : Location of cerebellar SS [baseline]

   Location of cerebellar SS (vermis, anterior lobe, posterior lobe)

3. MRI analyse : characteristics of cerebellar SS [baseline]

   number of cerebellar sulci involved

4. MRI analyse : characteristics of cerebellar SS [baseline]

   spatial relationship with cerebellar micro- and macrobleeds

5. MRI analyse : Presence of cerebellar macrobleeds [baseline]

   Presence of cerebellar macrobleeds (Yes/No)

6. MRI analyse : Presence of cerebral macrobleeds [baseline]

   Presence of cerebral macrobleeds (Yes/No)

7. MRI analyse : Characteristics of cerebral macrobleeds [baseline]

   spatial relationship of cerebral macrobleeds with the TC [adjacent vs. non-adjacent to TC]

8. MRI analyse : Characteristics of cortical SS [baseline]

   spatial relationship with TC (adjacent vs. non-adjacent to TC)

9. MRI analyse : hemosiderin [baseline]

   presence of hemosiderin deposition along the TC.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU de Nîmes	Nîmes		France	30029

Sponsors and Collaborators

• Centre Hospitalier Universitaire de Nīmes

Investigators

• Study Director: Anissa MEGZARI, Centre Hospitalier Universitaire de Nīmes

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre Hospitalier Universitaire de Nīmes
• ClinicalTrials.gov Identifier: NCT05394636
• Other Study ID Numbers: Local/2022/Dr-02
• First Posted: May 27, 2022
• Last Update Posted: Jun 6, 2022
• Last Verified: Jun 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Siderosis; Cerebral Amyloid Angiopathy; Cerebral Amyloid Angiopathy, Familial; Amyloidosis

Study Results

No Results Posted as of Jun 6, 2022