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Completed

NCT Number: NCT05394636

Cerebellar Superficial Siderosis in Cerebral Amyloid Angiopathy

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).

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Key information

Conditions

Cerebral Amyloid Angiopathy Amyloidosis Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebral Arterial Diseases Cerebrovascular Disorders Intracranial Arterial Diseases Lung Diseases Lung Diseases, Interstitial Lung Injury Metabolic Diseases Nervous System Diseases Nutritional and Metabolic Diseases Occupational Diseases Pneumoconiosis Proteostasis Deficiencies Respiratory Tract Diseases Siderosis Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Nîmes

Nîmes, 30029, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

None, pure observational study

Other

None, pure observational study

Primary outcomes

  1. MRI analyse : presence of cerebellar SS

    Time frame: baseline

    presence of cerebellar SS (Yes/No)

  2. MRI analyse : Location of cerebellar SS

    Time frame: baseline

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

  3. MRI analyse : characteristics of cerebellar SS

    Time frame: baseline

    number of cerebellar sulci involved

  4. MRI analyse : characteristics of cerebellar SS

    Time frame: baseline

    spatial relationship with cerebellar micro- and macrobleeds

  5. MRI analyse : Presence of cerebellar macrobleeds

    Time frame: baseline

    Presence of cerebellar macrobleeds (Yes/No)

  6. MRI analyse : Presence of cerebral macrobleeds

    Time frame: baseline

    Presence of cerebral macrobleeds (Yes/No)

  7. MRI analyse : Characteristics of cerebral macrobleeds

    Time frame: baseline

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

  8. MRI analyse : Characteristics of cortical SS

    Time frame: baseline

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

  9. MRI analyse : hemosiderin

    Time frame: baseline

    presence of hemosiderin deposition along the TC.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study title

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

Acronym: CSS

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
May 27, 2022
Registry last updated
Dec 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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