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Cortical Superficial Siderosis and Risk of Recurrent Intracerebral Hemorrhage in Cerebral Amyloid Angiopathy.

NCT ID: NCT03464344

Last Updated: 2025-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

170 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-12

Study Completion Date

2025-02-11

Brief Summary

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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.

Detailed Description

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Patients with acute lobar ICH fulfilling the Boston criteria for probable or possible CAA will be enrolled within 30 days after ICH onset. Brain MRI performed at baseline will be analyzed blinded to clinical data. Patients with presence of cSS will be compared with those without cSS.

During a systematic follow-up of 24 months, patients will undergo neurological, neuropsychological and MRI evaluation. The investigators will compare the rate of recurrent symptomatic ICH at 24 months in patients with vs. without cSS.

Conditions

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Cerebral Amyloid Angiopathy

Keywords

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intracerebral hemorrhage cerebral amyloid angiopathy cortical superficial siderosis Magnetic Resonance Imaging

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Patients with cortical superficial siderosis.

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

Group Type OTHER

neurological, neuropsychological and MRI evaluation

Intervention Type OTHER

neurological, neuropsychological and MRI evaluation

Patients without cortical superficial siderosis

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

Group Type OTHER

neurological, neuropsychological and MRI evaluation

Intervention Type OTHER

neurological, neuropsychological and MRI evaluation

Interventions

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neurological, neuropsychological and MRI evaluation

neurological, neuropsychological and MRI evaluation

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

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

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Toulouse

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nicolas RAPOSO, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Lionel CALVIERE

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

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Pellegrin Hospital

Bordeaux, , France

Site Status

Gui de Chauliac Hospital

Montpellier, , France

Site Status

Lariboisière Hospital

Paris, , France

Site Status

CHU Purpan. Hôpital Pierre-Paul Riquet

Toulouse, , France

Site Status

Countries

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France

Other Identifiers

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2017-A01524-49

Identifier Type: OTHER

Identifier Source: secondary_id

RC31/16/8919

Identifier Type: -

Identifier Source: org_study_id