NCT05394636

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
111

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 24, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 27, 2022

Completed
5 days until next milestone

Study Start

First participant enrolled

June 1, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

December 4, 2025

Status Verified

December 1, 2022

Enrollment Period

7 months

First QC Date

May 24, 2022

Last Update Submit

November 26, 2025

Conditions

Outcome Measures

Primary Outcomes (9)

  • MRI analyse : presence of cerebellar SS

    presence of cerebellar SS (Yes/No)

    baseline

  • MRI analyse : Location of cerebellar SS

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

    baseline

  • MRI analyse : characteristics of cerebellar SS

    number of cerebellar sulci involved

    baseline

  • MRI analyse : characteristics of cerebellar SS

    spatial relationship with cerebellar micro- and macrobleeds

    baseline

  • MRI analyse : Presence of cerebellar macrobleeds

    Presence of cerebellar macrobleeds (Yes/No)

    baseline

  • MRI analyse : Presence of cerebral macrobleeds

    Presence of cerebral macrobleeds (Yes/No)

    baseline

  • MRI analyse : Characteristics of cerebral macrobleeds

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

    baseline

  • MRI analyse : Characteristics of cortical SS

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

    baseline

  • MRI analyse : hemosiderin

    presence of hemosiderin deposition along the TC.

    baseline

Study Arms (1)

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

Interventions

None, pure observational study

cerebral amyloid angiopathy (CAA)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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

You may qualify if:

  • CAA patients (according to the modified Boston criteria)
  • with acute symptoms related to acute ICH, acute subarachnoid haemorrhage, or cortical SS

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Nîmes

Nîmes, 30029, France

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Cerebral Amyloid AngiopathySiderosis

Condition Hierarchy (Ancestors)

Cerebral Arterial DiseasesIntracranial Arterial DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesAmyloidosisProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic DiseasesPneumoconiosisLung Diseases, InterstitialLung DiseasesRespiratory Tract DiseasesLung InjuryOccupational Diseases

Study Officials

  • Anissa MEGZARI

    Centre Hospitalier Universitaire de Nīmes

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 24, 2022

First Posted

May 27, 2022

Study Start

June 1, 2022

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

December 4, 2025

Record last verified: 2022-12

Locations