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 )

Completed

• Conditions: Cerebral Amyloid Angiopathy; Stroke; Hemorrhage
• Interventions: Other: None, pure observational study

• Registration Number: NCT05565144
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2022-09-23
• Study Start: 2022-10-02
• Study First Submitted QC: 2022-10-03
• Study First Posted: 2022-10-04
• Primary Completion: 2023-04-24
• Study Completion: 2023-04-24
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-12
• Last Update Posted: 2024-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
cerebral amyloid angiopathy (CAA)	None, pure observational study	Patients with CAA treated with intravenous thrombolysis

Primary Outcome Measures

Name	Time	Method
brain hemorrhage	24 hours after intravenous thrombolysis (IVT)	brain hemorrhage on non-enhanced CT at 24 hours after IVT (Yes/No)
functional outcome	Up to 3 months. From date of symptom onset until date of hospital discharge, assessed up to 3 months.	functional outcome at hospital discharge according to the modified Rankin scale (Poor/Good)

Trial Locations

Locations (1)

CHU de Nîmes; 🇫🇷 Nimes, France