HemorrhageThromb in CAANCT05565144
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 )
An observational study of Hemorrhage and Cerebral Amyloid Angiopathy, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemorrhage, Cerebral Amyloid Angiopathy, Stroke
- What is being tested?
- None, pure observational study
- Type of treatment
- Injection or infusion
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 2 Oct 2022to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- patients with ongoing anticoagulation therapy
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- None, pure observational study
- Keywords
- functional outcome
- Medical subject headings
- Hemorrhage, Cerebral Amyloid Angiopathy, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
None, pure observational studyOther
None, pure observational study
| Study group | Role | What they receive |
|---|---|---|
| cerebral amyloid angiopathy (CAA) | Patients with CAA treated with intravenous thrombolysis Receives: Other: None, pure observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
brain hemorrhage
brain hemorrhage on non-enhanced CT at 24 hours after IVT (Yes/No)
Measured: 24 hours after intravenous thrombolysis (IVT)
functional outcome
functional outcome at hospital discharge according to the modified Rankin scale (Poor/Good)
Measured: Up to 3 months. From date of symptom onset until date of hospital discharge, assessed up to 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2022
- Study start2 Oct 2022
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HemorrhageStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anissa MEGZARI, Study director, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05565144
- Sponsor's protocol ID
- LOCAL/2022/DR-03
- Acronym
- Thromb in CAA
- Status last verified
- Dec 2025
- First submitted
- 23 Sep 2022
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36442282
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05565144
- Acronym / sponsor ID
- Thromb in CAA / LOCAL/2022/DR-03
- Conditions
- Hemorrhage, Cerebral Amyloid Angiopathy, Stroke
- Keywords
- functional outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 2 Oct 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 4 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cerebral amyloid angiopathy (CAA) | – | Other: None, pure observational studyPatients with CAA treated with intravenous thrombolysis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- patients with ongoing anticoagulation therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| None, pure observational studyNone, pure observational study | Other | cerebral amyloid angiopathy (CAA) |
Primary outcome
brain hemorrhage
Time frame: 24 hours after intravenous thrombolysis (IVT)
brain hemorrhage on non-enhanced CT at 24 hours after IVT (Yes/No)
functional outcome
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
- Results publication: PubMed 36442282Leonte 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anissa MEGZARI study director
Centre Hospitalier Universitaire de Nīmes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemorrhage and Cerebral Amyloid Angiopathy, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
brain hemorrhage (time frame: 24 hours after intravenous thrombolysis (IVT)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05565144, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025.