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 )

Stroke Clinical Trial

— Thromb in CAA  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05565144
• Other study ID #: LOCAL/2022/DR-03
• Status: Completed
• Start date: October 2, 2022
• Est. completion date: April 24, 2023

Study information

• Verified date: January 2024
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: April 24, 2023
• Est. primary completion date: April 24, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Amyloidosis
• Cerebral Amyloid Angiopathy
• Hemorrhage
• Intracranial Hemorrhages
• Stroke

Intervention

Other:
• None, pure observational study
None, pure observational study

Locations

Country	Name	City	State
France	CHU de Nîmes	Nimes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

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