Clinical trial NCT05565144: 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 )
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemorrhage
Cerebral Amyloid Angiopathy
Stroke
Keywords: functional outcome
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2022-10-04
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: consecutive IVT-treated stroke patientswith CAA features (strictly lobar CMB, CSS, or chronic lobar ICH) on pre-treatment MRI therapy registered in our stroke database between January 2015 and July 2022

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.


Eligibility criteria: 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

Primary outcomes:
measure: brain hemorrhage
timeFrame: 24 hours after intravenous thrombolysis (IVT)
measure: functional outcome
timeFrame: Up to 3 months. From date of symptom onset until date of hospital discharge, assessed up to 3 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Nimes
country: France
facility: CHU de Nîmes
Study officials:
affiliation: Centre Hospitalier Universitaire de Nīmes
name: Anissa MEGZARI
role: STUDY_DIRECTOR
References: