NCT03464344

Brief Summary

Cerebral amyloid angiopathy (CAA) is a major cause of lobar intracerebral hemorrhage (ICH) in the elderly with high risk of recurrence. The investigators aim to determine the relationship between cortical superficial siderosis (cSS), a MRI hemorrhagic marker of CAA and the risk of symptomatic ICH recurrence in a multicentric prospective cohort of patients with acute lobar ICH related to CAA. The investigators hypothesize that patients with cSS have an increased risk of recurrent symptomatic ICH relative to those without cSS.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
170

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

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

March 7, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 14, 2018

Completed
7 months until next milestone

Study Start

First participant enrolled

October 12, 2018

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 11, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 11, 2025

Completed
Last Updated

December 31, 2025

Status Verified

December 1, 2025

Enrollment Period

6.3 years

First QC Date

March 7, 2018

Last Update Submit

December 23, 2025

Conditions

Cerebral Amyloid Angiopathy

Keywords

intracerebral hemorrhagecerebral amyloid angiopathycortical superficial siderosisMagnetic Resonance Imaging

Outcome Measures

Primary Outcomes (1)

  • Recurrent symptomatic intracerebral hemorrhage at 24 months

    Recurrent symptomatic intracerebral haemorrhage is defined as a further intracerebral hemorrhage documented by CT scan or MRI, associated with new neurologic symptoms

    24 months

Secondary Outcomes (7)

  • Recurrent symptomatic ICH at 12 months

    12 months

  • Transient Focal Neurological Episodes (TFNE) at 12 and 24 months

    12 and 24 months

  • mortality or dependance at 12 and 24 months

    12 and 24 months

  • Cognitive decline at 12 and 24 months

    12 and 24 months

  • New MRI hemorrhagic lesion at 12 months

    12 months

  • +2 more secondary outcomes

Study Arms (2)

Patients with cortical superficial siderosis.

OTHER

During a systematic follow-up of 24 months, patients will undergo neurological, neuropsychological and MRI evaluation

Other: neurological, neuropsychological and MRI evaluation

Patients without cortical superficial siderosis

OTHER

During a systematic follow-up of 24 months, patients will undergo neurological, neuropsychological and MRI evaluation

Other: neurological, neuropsychological and MRI evaluation

Interventions

neurological, neuropsychological and MRI evaluationOTHER

neurological, neuropsychological and MRI evaluation

Patients with cortical superficial siderosis.Patients without cortical superficial siderosis

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Lobar ICH within 30 days after onset
  • Available brain MRI sequences of adequate quality including fluid-attenuated inversion recovery (FLAIR) and T2\*-weighted gradient-recalled echo (T2\*-GRE) sequences.
  • Modified Boston criteria for probable or possible CAA
  • Age ≥ 55 years
  • Written consent

You may not qualify if:

  • Secondary brain hemorrhage : vascular malformation (arteriovenous malformation, aneurysm, cavernous); cerebral veinous thrombosis; brain tumor; coagulopathy; vasculitis; hemorrhagic infarction,
  • Infratentorial siderosis
  • Contraindications to MRI
  • Progressive neoplasm
  • Patient without affiliation to the french social security
  • Patient under guardianship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Pellegrin Hospital

Bordeaux, France

Location

Gui de Chauliac Hospital

Montpellier, France

Location

Lariboisière Hospital

Paris, France

Location

CHU Purpan. Hôpital Pierre-Paul Riquet

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Cerebral Amyloid AngiopathyCerebral Hemorrhage

Condition Hierarchy (Ancestors)

Cerebral Arterial DiseasesIntracranial Arterial DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesAmyloidosisProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic DiseasesIntracranial HemorrhagesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Nicolas RAPOSO, MD

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

  • Lionel CALVIERE

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2018

First Posted

March 14, 2018

Study Start

October 12, 2018

Primary Completion

February 11, 2025

Study Completion

February 11, 2025

Last Updated

December 31, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

FR(4)