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 )

NCT05565144 | Completed

• 1 other identifier: LOCAL/2022/DR-03
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemorrhage; Cerebral Amyloid Angiopathy; Stroke

Keywords

functional outcome

Outcome Measures

Primary Outcomes (2)

• brain hemorrhage

  brain hemorrhage on non-enhanced CT at 24 hours after IVT (Yes/No)

  24 hours after intravenous thrombolysis (IVT)

• 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.

Study Arms (1)

cerebral amyloid angiopathy (CAA)

Patients with CAA treated with intravenous thrombolysis

Other: None, pure observational study

Interventions

None, pure observational study OTHER

None, pure observational study

cerebral amyloid angiopathy (CAA)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• patients with ongoing anticoagulation therapy

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

CHU de Nîmes

Nîmes, 30029, France

Location

Related Publications (1)

• 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.

  PMID: 36442282 RESULT

MeSH Terms

Conditions

Hemorrhage; Cerebral Amyloid Angiopathy; Stroke

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cerebral Arterial Diseases; Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Amyloidosis; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Anissa MEGZARI

  Centre Hospitalier Universitaire de Nīmes

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2022
• First Posted: October 4, 2022
• Study Start: October 2, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: December 10, 2025

Record last verified: 2025-12

Locations

FR (1)