StrokeBRAIN IRMNCT04456309
Brain MRI in Stroke Patients With Intracardiac Thrombus
An observational study of Stroke and Intracardiac Thrombus, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
Acute infarction patterns have been described in cardioembolic stroke, mainly with atrial fibrillation (AF) or patent foramen ovale. We aimed to analyse acute infarction MRI characteristics in stroke patients with intracardiac thrombus (ICT) compared with stroke patients with AF. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Intracardiac Thrombus
- How many people
- 122 participants
- Where
- 1 siteFrance
- Study dates
- 1 May 2020to 31 Dec 2020
- 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: 2 groups of patients : 1 - Stroke patients with atrial fibrillation 2- Stroke patients with intracardiac thrombus
Who may be able to join
- consecutive patients presenting with acute symptomatic cardioembolic infarction associated with ICT, recruited and registered in the stroke database between June 2018 and November 2019 of our centre (Nîmes University Hospital, France). These patients were compared with consecutive cardioembolic stroke patients with known or newly discovered AF (in the absence of ICT on echocardiography), recruited during the same time period.
- Brain MRI (including diffusion-weighted imaging [DWI]) performed within one week of symptom onset; complete etiological work-up including intracranial (time-of-flight [TOF], gadolinium-enhanced magnetic resonance angiography [MRA], or computed tomographic angiography [CTA]) and extracranial (gadolinium-enhanced MRA, CTA, or duplex ultrasound) vessel imaging; transthoracic or transoesophageal echocardiography; and ≥24h ECG monitoring (acute stroke unit monitoring and/or Holter ECG monitoring).
Who cannot join
- opt-out patient
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Brain MRI Characteristics in Stroke Patients With Intracardiac Thrombus
Acute infarction patterns have been described in cardioembolic stroke, mainly with atrial fibrillation (AF) or patent foramen ovale. We aimed to analyse acute infarction MRI characteristics in stroke patients with intracardiac thrombus (ICT) compared with stroke patients with AF.
- Conditions
- Stroke, Intracardiac Thrombus
- Being tested
- No intervention,
- Keywords
- brain MRI
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention,Other
pure observational study
| Study group | Role | What they receive |
|---|---|---|
| Atrial fibrillation | stroke patients with atrial fibrillation Receives: Other: No intervention, | |
| Intracardiac thrombus | stroke patients with intracardiac thrombus Receives: Other: No intervention, |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain MRI characteristics
infarction location (anterior/middle/posterior cerebral artery territory; anterior/posterior/mixed anterior-posterior circulation; multiterritorial infarction; brainstem; cerebellum; small cortical cerebellar infarctions [SCCI] or non-SCCI; cortical/subcortical/corticosubcortical)
Measured: Day of inclusion (Day 1)
Brain MRI characteristics
lesion number
Measured: Day of inclusion (Day 1)
Brain MRI characteristics
subcortical lesion size (><15 mm)
Measured: Day of inclusion (Day 1)
Brain MRI characteristics
total infarction volume.
Measured: Day of inclusion (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2020
- Study start1 May 2020
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies 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
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dimitri RENARD, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04456309
- Sponsor's protocol ID
- LOCAL/2020/DR-02
- Acronym
- BRAIN IRM
- Status last verified
- Nov 2020
- First submitted
- 22 Jun 2020
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Renard D, Castelnovo G, Ion I, Guillamo JS, Thouvenot E. Single and simultaneous multiple intracerebral hemorrhages: a radiological review. Acta Neurol Belg. 2020 Aug;120(4):819-829. doi: 10.1007/s13760-020-01385-4. Epub 2020 May 24.
PubMed 32449137Trandafir C, Sandiramourty S, Laurent-Chabalier S, Ter Schiphorst A, Nguyen H, Wacongne A, Ricci JE, Pereira F, Thouvenot E, Renard D. Brain Infarction MRI Pattern in Stroke Patients with Intracardiac Thrombus. Cerebrovasc Dis. 2021;50(5):581-587. doi: 10.1159/000515707. Epub 2021 Jun 17.
PubMed 34139688
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain MRI Characteristics in Stroke Patients With Intracardiac Thrombus
- ClinicalTrials.gov ID
- NCT04456309
- Acronym / sponsor ID
- BRAIN IRM / LOCAL/2020/DR-02
- Conditions
- Stroke, Intracardiac Thrombus
- Keywords
- brain MRI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 2 Jul 2020 (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.
Acute infarction patterns have been described in cardioembolic stroke, mainly with atrial fibrillation (AF) or patent foramen ovale. We aimed to analyse acute infarction MRI characteristics in stroke patients with intracardiac thrombus (ICT) compared with stroke patients with AF.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atrial fibrillation | – | Other: No intervention,stroke patients with atrial fibrillation |
| Intracardiac thrombus | – | Other: No intervention,stroke patients with intracardiac thrombus |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 2 groups of patients : 1 - Stroke patients with atrial fibrillation 2- Stroke patients with intracardiac thrombus
Key inclusion criteria (2 listed)
- consecutive patients presenting with acute symptomatic cardioembolic infarction associated with ICT, recruited and registered in the stroke database between June 2018 and November 2019 of our centre (Nîmes University Hospital, France). These patients were compared with consecutive cardioembolic stroke patients with known or newly discovered AF (in the absence of ICT on echocardiography), recruited during the same time period.
- Brain MRI (including diffusion-weighted imaging [DWI]) performed within one week of symptom onset; complete etiological work-up including intracranial (time-of-flight [TOF], gadolinium-enhanced magnetic resonance angiography [MRA], or computed tomographic angiography [CTA]) and extracranial (gadolinium-enhanced MRA, CTA, or duplex ultrasound) vessel imaging; transthoracic or transoesophageal echocardiography; and ≥24h ECG monitoring (acute stroke unit monitoring and/or Holter ECG monitoring).
Key exclusion criteria (1 listed)
- opt-out patient
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 |
|---|---|---|
| No intervention,pure observational study | Other | Atrial fibrillation, Intracardiac thrombus |
Primary outcome
Brain MRI characteristics
Time frame: Day of inclusion (Day 1)
infarction location (anterior/middle/posterior cerebral artery territory; anterior/posterior/mixed anterior-posterior circulation; multiterritorial infarction; brainstem; cerebellum; small cortical cerebellar infarctions [SCCI] or non-SCCI; cortical/subcortical/corticosubcortical)
Brain MRI characteristics
Time frame: Day of inclusion (Day 1)
lesion number
Brain MRI characteristics
Time frame: Day of inclusion (Day 1)
subcortical lesion size (><15 mm)
Brain MRI characteristics
Time frame: Day of inclusion (Day 1)
total infarction volume.
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 4 Dec 2025.
- Results publication: PubMed 32449137Renard D, Castelnovo G, Ion I, Guillamo JS, Thouvenot E. Single and simultaneous multiple intracerebral hemorrhages: a radiological review. Acta Neurol Belg. 2020 Aug;120(4):819-829. doi: 10.1007/s13760-020-01385-4. Epub 2020 May 24.
- Derived from this study: PubMed 34139688Trandafir C, Sandiramourty S, Laurent-Chabalier S, Ter Schiphorst A, Nguyen H, Wacongne A, Ricci JE, Pereira F, Thouvenot E, Renard D. Brain Infarction MRI Pattern in Stroke Patients with Intracardiac Thrombus. Cerebrovasc Dis. 2021;50(5):581-587. doi: 10.1159/000515707. Epub 2021 Jun 17.
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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.
Dimitri RENARD principal investigator
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 Stroke and Intracardiac Thrombus, 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 4 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 MRI characteristics (time frame: Day of inclusion (Day 1)). The study lists 4 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 NCT04456309, which also lists 2 linked publications.
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 4 Dec 2025.