Brain Hemorrhage and Functional Outcome in Stroke Patients With CAA Features on Pre-thrombolysis MRI Treated With Intravenous Thrombolysis (Thrombolysis in CAA) ( Thromb in CAA )

NCT ID: NCT05565144

Last Updated: 2025-12-10

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

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-02

Study Completion Date

2022-12-31

Brief Summary

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Background: In stroke patients treated with intravenous thrombolysis (IVT), presence and high number of strictly lobar cerebral microbleeds (compatible with cerebral amyloid angiopathy, CAA) seems to be associated with increased risk of hemorrhagic transformation, symptomatic hemorrhagic transformation, remote hemorrhage, and poor functional outcome. Some of these reported CAA patients with cerebral microbleeds also had chronic lobar intracerebral haemorrhage. Few data is available on IVT-treated CAA patients showing cortical superficial siderosis. There are no reports studying factors associated with brain hemorrhagic complication or functional outcome inside a group of IVT-treated CAA patients. Our aim was to evaluate brain hemorrhagic complications on 24h-CT and functional outcome after IVT in stroke patients with CAA features on pre-IVT MRI.

Methods: In our stroke center, IVT decision in patients with CAA MRI features is left at the discretion of the treating physician. We retrospectively screened pre-IVT imaging of 959 consecutive IVT-treated stroke patients (between January 2015 and July 2022) without ongoing anticoagulation therapy for probable CAA MRI features defined by modified Boston criteria. After exclusion of 119 patients with lacking MRI (n=47), with MRI showing motion artefacts (n=49) or with alternative chronic brain hemorrhage cause on MRI (n=23), 15 IVT-treated patients with probable CAA on pre-IVT MRI were identified. In these 15 patients, clinical, biological and MRI characteristics were compared between patients with vs. without post-IVT hemorrhage and between patients with poor (MRS 3-6) vs. good (MRS 0-2) functional outcome at discharge.

Detailed Description

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Conditions

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Hemorrhage Cerebral Amyloid Angiopathy Stroke

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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cerebral amyloid angiopathy (CAA)

Patients with CAA treated with intravenous thrombolysis

None, pure observational study

Intervention Type OTHER

None, pure observational study

Interventions

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None, pure observational study

None, pure observational study

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Consecutive IVT-treated stroke patients without ongoing anticoagulation therapy registered in our stroke database presenting probable CAA on pre-IVT MRI
* Patient taken in charge at the CHU of Nîmes between January 2015 and July 2022

Exclusion Criteria

* patients with ongoing anticoagulation therapy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anissa MEGZARI

Role: STUDY_DIRECTOR

Centre Hospitalier Universitaire de Nīmes

Locations

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CHU de Nîmes

Nîmes, , France

Site Status

Countries

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France

References

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Leonte A, Laurent-Chabalier S, Wacongne A, Parvu T, Hackius M, Thouvenot E, Renard D. Brain hemorrhage on 24h-CT and functional outcome in stroke patients with cerebral amyloid angiopathy features on pre-thrombolysis MRI treated with intravenous thrombolysis: A case series. J Stroke Cerebrovasc Dis. 2023 Feb;32(2):106907. doi: 10.1016/j.jstrokecerebrovasdis.2022.106907. Epub 2022 Nov 25.

Reference Type RESULT
PMID: 36442282 (View on PubMed)

Other Identifiers

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LOCAL/2022/DR-03

Identifier Type: -

Identifier Source: org_study_id

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