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 )

Sponsor

Centre Hospitalier Universitaire de Nīmes (Other)

Overall Status

Recruiting

CT.gov ID

NCT05565144

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hemorrhage Cerebral Amyloid Angiopathy Stroke	Other: None, pure observational study

Study Design

Study Type:

Observational

Anticipated Enrollment :

15 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Brain Hemorrhage on 24h-CT and Functional Outcome in Stroke Patients With Cerebral Amyloid Angiopathy Features on Pre-thrombolysis MRI Treated With Intravenous Thrombolysis

Actual Study Start Date :

Oct 2, 2022

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
cerebral amyloid angiopathy (CAA) Patients with CAA treated with intravenous thrombolysis	Other: None, pure observational study None, pure observational study

Arm

Intervention/Treatment

cerebral amyloid angiopathy (CAA)

Patients with CAA treated with intravenous thrombolysis

Other: None, pure observational study

None, pure observational study

Outcome Measures

Primary Outcome Measures

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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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