StrokeFIBROSIS-MRINCT06047782
Impact of Atrial Fibrosis Surface Area on the Occurrence of Atrial Fibrillation in Patients With Ischemic Stroke of Undetermined Origin: a Prospective Cardiac MRI Pilot Study.
A study testing Cardiac MRI (with contrast agent) in people with Stroke and Implantation of an Implantable Cardiac Monitor, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
Atrial fibrillation is a cardiac arrhythmia most often originating in the left atrium, causing anarchic electrical activity and thus a loss of atrial contraction. This increases the risk of stroke through clot formation in the atrium, but also of heart failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Implantation of an Implantable Cardiac Monitor
- What is being tested?
- Cardiac MRI (with contrast agent)
- How many people
- 157 participants
- Where
- 1 siteFrance
- Study dates
- 31 Jan 2024to Jan 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Patient who has provided free, written and informed consent
- Patient of legal age
- Patient with cryptogenic ischemic stroke within 30 days of inclusion, documented by brain imaging (cerebral angioscan or cerebral MRI)
- Patients scheduled for implantable loop recorder implantation within 3 months of ischemic stroke in search of silent AF:
- cryptogenic ischemic stroke or stroke with probable cardioembolic cause
- no history of atrial fibrillation
- no long-term anticoagulant therapy
- with life expectancy >12 months
Who cannot join
- Person not affiliated to national health insurance
- Person under legal protection (curatorship, guardianship)
- Person under court order
- Pregnant, parturient or breast-feeding
- Adult unable to give consent
- Patient diagnosed with AF during stroke assessment
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- Patient with a contraindication to MRI or gadolinium injection:
- Severe renal impairment (<30ml/min Cockroft clearance due to gadolinium injection)
- Claustrophobia / contraindication to MRI (metal implant not MRI compatible)
- History of hypersensitivity to gadoteric acid or gadolinium-based contrast agents, and to meglumine
- Uncontrolled asthma
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Chu Dijon Bourgogne
Dijon
Charles GUENANCIA, 0380295623, charles.guenancia@chu-dijon.fr
About this study
Atrial fibrillation is a cardiac arrhythmia most often originating in the left atrium, causing anarchic electrical activity and thus a loss of atrial contraction. This increases the risk of stroke through clot formation in the atrium, but also of heart failure. Atrial fibrillation is a major cause of stroke, accounting for more than 25% of all strokes. In addition, a quarter of ischemic strokes remain without an obvious cause at the end of hospitalization, and it is recommended that atrial fibrillation be detected intensively with long-term heart rhythm recording. Implantable loop recorders can detect 30% of atrial fibrillation cases over the 3-year battery life of these devices, after a stroke of undetermined origin. However, these devices require a small operation to implant them under the skin, and they are expensive.
The hypothesis of this study is that MRI imaging of the left atrium would enable better selection of patients to receive an implantable loop recorder. MRI can quantify the proportion of the left atrium with scar tissue, which is likely to favour the onset of atrial fibrillation. If the results confirm this hypothesis, the number of patients requiring an implantable loop recorder could be reduced, and perhaps an anticoagulation strategy based on MRI data could be introduced.
In addition to the usual follow-up by cardiologists and neurologists, participation in this study involves a cardiac MRI (with contrast agent) within 3 months of the stroke.
- Being tested
- Cardiac MRI (with contrast agent)
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac MRI (with contrast agent)Other
Cardiac MRI with contrast agent
What is being measured
The primary outcome is the main question the study is designed to answer.
Episode of atrial fibrillation (AF) lasting more than 30 seconds on the implantable loop recorder
Measured: at 3-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start31 Jan 2024
- Primary completionJan 2031 (estimated)
- Study completionJan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 157 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06047782
- Sponsor's protocol ID
- GUENANCIA FRAVC 2022
- Acronym
- FIBROSIS-MRI
- Status last verified
- Oct 2026
- First submitted
- 5 Sep 2023
- Last updated
- 26 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Atrial Fibrosis Surface Area on the Occurrence of Atrial Fibrillation in Patients With Ischemic Stroke of Undetermined Origin: a Prospective Cardiac MRI Pilot Study.
- ClinicalTrials.gov ID
- NCT06047782
- Acronym / sponsor ID
- FIBROSIS-MRI / GUENANCIA FRAVC 2022
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 157 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 31 Jan 2024 (actual)
- Primary completion
- Jan 2031 (estimated)
- Study completion
- Jan 2031 (estimated)
- First posted
- 21 Sep 2023 (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.
Atrial fibrillation is a cardiac arrhythmia most often originating in the left atrium, causing anarchic electrical activity and thus a loss of atrial contraction. This increases the risk of stroke through clot formation in the atrium, but also of heart failure. Atrial fibrillation is a major cause of stroke, accounting for more than 25% of all strokes. In addition, a quarter of ischemic strokes remain without an obvious cause at the end of hospitalization, and it is recommended that atrial fibrillation be detected intensively with long-term heart rhythm recording. Implantable loop recorders can detect 30% of atrial fibrillation cases over the 3-year battery life of these devices, after a stroke of undetermined origin. However, these devices require a small operation to implant them under the skin, and they are expensive.
The hypothesis of this study is that MRI imaging of the left atrium would enable better selection of patients to receive an implantable loop recorder. MRI can quantify the proportion of the left atrium with scar tissue, which is likely to favour the onset of atrial fibrillation. If the results confirm this hypothesis, the number of patients requiring an implantable loop recorder could be reduced, and perhaps an anticoagulation strategy based on MRI data could be introduced.
In addition to the usual follow-up by cardiologists and neurologists, participation in this study involves a cardiac MRI (with contrast agent) within 3 months of the stroke.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient who has provided free, written and informed consent
- Patient of legal age
- Patient with cryptogenic ischemic stroke within 30 days of inclusion, documented by brain imaging (cerebral angioscan or cerebral MRI)
- Patients scheduled for implantable loop recorder implantation within 3 months of ischemic stroke in search of silent AF:
Key exclusion criteria (11 listed)
- Person not affiliated to national health insurance
- Person under legal protection (curatorship, guardianship)
- Person under court order
- Pregnant, parturient or breast-feeding
- Adult unable to give consent
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 |
|---|---|---|
| Cardiac MRI (with contrast agent)Cardiac MRI with contrast agent | Other | – |
Primary outcome
Episode of atrial fibrillation (AF) lasting more than 30 seconds on the implantable loop recorder
Time frame: at 3-year follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac MRI (with contrast agent) in people with Stroke and Implantation of an Implantable Cardiac Monitor, run by Centre Hospitalier Universitaire Dijon 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 8 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 26 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Charles GUENANCIA (0380295623, charles.guenancia@chu-dijon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Episode of atrial fibrillation (AF) lasting more than 30 seconds on the implantable loop recorder (time frame: at 3-year follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Oct 2026.