Embolic Stroke of Undetermined SourceIRM 4D-AVCNCT04717843
Identification of New Markers of Atrial Myopathy in Patients With Embolic Stroke of Undetermined Source (ESUS) From MRI 4D Data
A study testing 4D Flow MRI, Medical consultation with 12 leads ECG and Holter ECG in people with Embolic Stroke of Undetermined Source, run by Hospices Civils de Lyon at 3 sites in France.
Trial summary
Atrial myopathy is considered to be the underlying cause of a large proportion of embolic strokes of undetermined source. However, the definition of this atrial condition is not well delineated while its identification could lead to prescription on anticoagulation in order to avoid stroke recurences. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Embolic Stroke of Undetermined Source
- What is being tested?
- 4D Flow MRI, Medical consultation with 12 leads ECG and Holter ECG
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 3 sitesFrance
- Study dates
- 1 Mar 2021to 1 Sep 2024
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Groupe1:Ischemic embolic stroke of undetermined source (ESUS) according to TOAST criteria (N =10)
- Age ≥ 18 years old
- Non-gap ischemic stroke diagnosed on MRI or CT scan of the brain (gap stroke defined as a cerebral infarction ≤ 1.5 cm / ≤2.0 cm on diffusion sequences).
- No major cardio-embolic source (episode of atrial fibrillation or flutter > 6min, intracardiac thrombus, LVEF <30 percent recent myocardial infarction (<4 weeks), mitral stenosis, valvular vegetation or infectious endocarditis).
- Absence of atherosclerosis causing stenosis ≥ 50 percent of the lumen of the intra or extra cranial arteries that vascularise the infarcted cerebral area.
- No other specific cause identified (arteritis, arterial dissection, migraine/vaso-spasm, toxic cause).
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- Affiliation to a social security scheme
- Patient who signed the consent
- Group 2: Non-paroxysmal AF (N=10)
- Age ≥ 18 years old
- Subject with documented non-paroxysmal AF
- Affiliation to a social security scheme
- Patient who signed the consent
- Group 3: Healthy volunteers (N=10)
- Pre-inclusion criteria :
- Age ≥ 45 years old
- Patient with no documented cardiac or neuro-vascular history
- Affiliation to a social security scheme
- Patient who signed the consent
- Registration on the VRB file (Volontaires Recherches Biomédicales, https://vrb.sante.gouv.fr) or response to the published announcement
- Criteria for inclusion :
- ECG in sinus rhythm
- Holter ECG: no AF
- Normal Trans thoracic echocardiography
- Patient with no neuro-vascular history
- Group 4: Stroke-ESUS or non-paroxysmal AF with cardiac MRI (N=10)
- Age ≥ 18 years old
- Subject with a documented stroke-ESUS or documented non-paroxysmal FA
- Subject with cardiac MRI
- Affiliation to a social security scheme
- Subject having given its non-opposition
Who cannot join
- Groupe1: Ischemic embolic stroke of undetermined source (ESUS) according to TOAST criteria (N =10)
- Risk of pregnancy or pregnancy (proven on interrogation data or pregnancy test).
- Contraindication to MRI ferromagnetic material (in particular pacemaker, implantable defibrillator, cardiac valve prosthesis, cochlear implant, neuro-stimulator, implanted automated injection material, intraocular metallic foreign body, neurosurgical and vascular clips, claustrophobia)
- Less than 8 weeks after implantation of a stent
- Subject participating in another intervention research including a period of exclusion still in progress at the pre-inclusion stage.
- Group 2: Non-paroxysmal AF (N=10)
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- Risk of pregnancy or pregnancy (proven on interview data or pregnancy test).
- Contraindication to MRI ferromagnetic material (in particular pacemaker, implantable defibrillators, cardiac valve prosthesis, cochlear implant, neurostimulators, implanted automated injection equipment, intraocular metallic foreign body, neurosurgical and vascular clips, claustrophobia).
- Less than 8 weeks after implantation of a stent
- Subject participating in another intervention research including a period of exclusion still in progress at the pre-inclusion stage.
- Group 4: Stroke-ESUS or non paroxysmal AF with cardiac MRI (N=10)
- History of neuro-vascular or cardiac pathology
- Risk of pregnancy or pregnancy (proven on interrogation data or pregnancy test).
- Contraindication to MRI (ferromagnetic material (in particular pacemaker, implantable defibrillator, cardiac valve prosthesis, cochlear implant, neuro-stimulator, implanted automated injection material, intraocular metallic foreign body, neurosurgical and vascular clips, claustrophobia)
- Subject participating in another intervention research including a period of exclusion still in progress at the pre-inclusion stage.
Trial locations and contacts
3 sites in 1 country.
France3 sites, 3 recruiting
- Not yet recruiting
Service d'urgences neuro-vasculaires, service de neurologie vasculaire Hôpital neurologique Pierre Wertheimer
Bron, 69677
Laura MECHTOUFF, MD, 4.72.35.67.47 ext. +33, laura.mechtouff@chu-lyon.fr
- Not yet recruiting
Service Imagerie médicale Hôpital neurologique Pierre Wertheimer
Bron, 69677
Philippe DOUEK, Pr, 4.72.35.72.33 ext. +33, philippe.douek@chu-lyon.fr
- Recruiting
Service rythmologie, Hôpital cardiologique Louis Pradel
Bron, 69677
Philippe CHEVALIER, Pr, 4.72.35.70.17 ext. +33, philippe.chevalier@chu-lyon.fr
Sihem BEN AOUICHA, PhD, 4.72.35.76.77 ext. +33, sihem.ben-aouicha@chu-lyon.fr
About this study
Atrial myopathy is considered to be the underlying cause of a large proportion of embolic strokes of undetermined source. However, the definition of this atrial condition is not well delineated while its identification could lead to prescription on anticoagulation in order to avoid stroke recurences. This study aims to identify new markers of atrial myopathy and choosed a multi parametric approach with electrical, echographical, biological and 4D flow CMR derived markers.
- Conditions
- Embolic Stroke of Undetermined Source
- Being tested
- 4D Flow MRI, Medical consultation with 12 leads ECG, Holter ECG, Trans thoracic echocardiography, Blood sample
- Keywords
- Atrial Myopathy, Atrial Fibrillation, ESUS, MRI, blood velocity, left atrium
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4D Flow MRIOther
Acquisitions of MR imagining with special contrast phase CMR sequences. There is no need for agent contrast injection. The CMR is performed at the time of inclusion.
Medical consultation with 12 leads ECGOther
Collection of medical history, treatment, physical examination and realization of a 12 leads ECG.
Holter ECGOther
48 hours ECG recording
Trans thoracic echocardiographyOther
Trans thoracic echocardiography with standard measures performes in the core lab.
Blood sampleBiological
Blood sample in a peripheral vein, send to medical laboratory to dosage of NT pro BNP and troponin serum level.
Standard MRIOther
Acquisitions of MR imagining
| Study group | Role | What they receive |
|---|---|---|
| Patients with embolic strokes of undetermined source. | Experimental | Patients over 18 years old, with embolic strokes of undetermined source, fulfilling the TOAST criteria. The intervention consists of a 4D Flow MRI. Receives: Other: 4D Flow MRI |
| Patients with non-paroxysmal AF. | Experimental | Patients over 18 years old, with non-paroxysmal AF. The intervention consists of a 4D Flow MRI. Receives: Other: 4D Flow MRI |
| Heathy volunteers | Active comparator | The control group will include volunteers over 45 years old with no history of cardio-vascular or neuro-vascular disease. The last will be certified by a pre inclusion protocol containing a medical consultation, a Holter ECG and a trans-thoracic echocardiography. The age of 45 was chosen to get comparable age group and set the analyses free of the age-related effect on the cardiac hemodynamic. The intervention consists of an ECG, holter ECG, Trans thoracic echocardiography ETT, Blood sample and 4D Flow MRI. Receives: Other: 4D Flow MRI; Other: Medical consultation with 12 leads ECG; Other: Holter ECG; Other: Trans thoracic echocardiography; Biological: Blood sample |
| ESUS and non-paroxysmal AF patients with cardiac MRI | Experimental | ESUS and non-paroxysmal AF patients (fulfilling the group 1 et 2 criteria) and who had had cardiac MRI, in a retrospective way. It corresponds to retrospective inclusion of patients which had MRI in the year before the beginning of the study. Receives: Other: Standard MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean flow velocities in the left atrium
Velocity magnitude (cm/s) for all atrial voxels and all cardiac frames will be plotted in a histogram and normalized by the total number of voxels to allow comparisons between subjects
Measured: One Day
Secondary outcomes (4)
Maximal flow velocities in the left atrium
Velocity magnitude (cm/s) for all atrial voxels and all cardiac frames will be plotted in a histogram and normalized by the total number of voxels to allow comparisons between subjects. Local peak velocity will be obtained by averaging 5 percent of all maximum values.
Measured: One Day
Left atrium stasis
Velocity magnitude (cm/s) for all atrial voxels and all cardiac frames will be plotted in a histogram and normalized by the total number of voxels to allow comparisons between subjects. Local peak velocity will be obtained by averaging 5 percent of all maximum values
Measured: One Day
Vortex size
Vortices in the isolated LA chamber were detectedusing the Lambda2 (λ2) method, which is an objective and widelyaccepted method to identify 3D vortice.
Measured: One Day
Left atrium volume
Extracted from 3D MR reconstruction, expressed in mL/m2 of body surface area.
Measured: One Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start1 Mar 2021
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Embolic Stroke of Undetermined SourceStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe CHEVALIER, Pr, Principal investigator, Chief of the Arrhythmia Unit at the Academic Hospital of Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04717843
- Sponsor's protocol ID
- 69HCL20_0790
- Acronym
- IRM 4D-AVC
- Status last verified
- Jun 2023
- First submitted
- 15 Jan 2021
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of New Markers of Atrial Myopathy in Patients With Embolic Stroke of Undetermined Source (ESUS) From MRI 4D Data
- ClinicalTrials.gov ID
- NCT04717843
- Acronym / sponsor ID
- IRM 4D-AVC / 69HCL20_0790
- Conditions
- Embolic Stroke of Undetermined Source
- Keywords
- Atrial Myopathy, Atrial Fibrillation, ESUS, MRI, blood velocity, left atrium
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 22 Jan 2021 (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 myopathy is considered to be the underlying cause of a large proportion of embolic strokes of undetermined source. However, the definition of this atrial condition is not well delineated while its identification could lead to prescription on anticoagulation in order to avoid stroke recurences. This study aims to identify new markers of atrial myopathy and choosed a multi parametric approach with electrical, echographical, biological and 4D flow CMR derived markers.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Patients with embolic strokes of undetermined source. | Experimental | Other: 4D Flow MRIPatients over 18 years old, with embolic strokes of undetermined source, fulfilling the TOAST criteria. The intervention consists of a 4D Flow MRI. |
| Patients with non-paroxysmal AF. | Experimental | Other: 4D Flow MRIPatients over 18 years old, with non-paroxysmal AF. The intervention consists of a 4D Flow MRI. |
| Heathy volunteers | Active comparator | Other: 4D Flow MRI, Other: Medical consultation with 12 leads ECG, Other: Holter ECG, Other: Trans thoracic echocardiography, Biological: Blood sampleThe control group will include volunteers over 45 years old with no history of cardio-vascular or neuro-vascular disease. The last will be certified by a pre inclusion protocol containing a medical consultation, a Holter ECG and a trans-thoracic echocardiography. The age of 45 was chosen to get comparable age group and set the analyses free of the age-related effect on the cardiac hemodynamic. The intervention consists of an ECG, holter ECG, Trans thoracic echocardiography ETT, Blood sample and 4D Flow MRI. |
| ESUS and non-paroxysmal AF patients with cardiac MRI | Experimental | Other: Standard MRIESUS and non-paroxysmal AF patients (fulfilling the group 1 et 2 criteria) and who had had cardiac MRI, in a retrospective way. It corresponds to retrospective inclusion of patients which had MRI in the year before the beginning of the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (31 listed)
- Groupe1:Ischemic embolic stroke of undetermined source (ESUS) according to TOAST criteria (N =10)
- Age ≥ 18 years old
- Non-gap ischemic stroke diagnosed on MRI or CT scan of the brain (gap stroke defined as a cerebral infarction ≤ 1.5 cm / ≤2.0 cm on diffusion sequences).
- No major cardio-embolic source (episode of atrial fibrillation or flutter > 6min, intracardiac thrombus, LVEF <30 percent recent myocardial infarction (<4 weeks), mitral stenosis, valvular vegetation or infectious endocarditis).
- Absence of atherosclerosis causing stenosis ≥ 50 percent of the lumen of the intra or extra cranial arteries that vascularise the infarcted cerebral area.
Key exclusion criteria (15 listed)
- Groupe1: Ischemic embolic stroke of undetermined source (ESUS) according to TOAST criteria (N =10)
- Risk of pregnancy or pregnancy (proven on interrogation data or pregnancy test).
- Contraindication to MRI ferromagnetic material (in particular pacemaker, implantable defibrillator, cardiac valve prosthesis, cochlear implant, neuro-stimulator, implanted automated injection material, intraocular metallic foreign body, neurosurgical and vascular clips, claustrophobia)
- Less than 8 weeks after implantation of a stent
- Subject participating in another intervention research including a period of exclusion still in progress at the pre-inclusion stage.
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 |
|---|---|---|
| 4D Flow MRIAcquisitions of MR imagining with special contrast phase CMR sequences. There is no need for agent contrast injection. The CMR is performed at the time of inclusion. | Other | Heathy volunteers, Patients with embolic strokes of undetermined source., Patients with non-paroxysmal AF. |
| Medical consultation with 12 leads ECGCollection of medical history, treatment, physical examination and realization of a 12 leads ECG. | Other | Heathy volunteers |
| Holter ECG48 hours ECG recording | Other | Heathy volunteers |
| Trans thoracic echocardiographyTrans thoracic echocardiography with standard measures performes in the core lab. | Other | Heathy volunteers |
| Blood sampleBlood sample in a peripheral vein, send to medical laboratory to dosage of NT pro BNP and troponin serum level. | Biological | Heathy volunteers |
| Standard MRIAcquisitions of MR imagining | Other | ESUS and non-paroxysmal AF patients with cardiac MRI |
Primary outcome
Mean flow velocities in the left atrium
Time frame: One Day
Velocity magnitude (cm/s) for all atrial voxels and all cardiac frames will be plotted in a histogram and normalized by the total number of voxels to allow comparisons between subjects
4 secondary outcomes
Maximal flow velocities in the left atrium
Time frame: One Day
Left atrium stasis
Time frame: One Day
Vortex size
Time frame: One Day
Left atrium volume
Time frame: One Day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
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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.
Philippe CHEVALIER, Pr principal investigator
Chief of the Arrhythmia Unit at the Academic Hospital of Lyon
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 4D Flow MRI, Medical consultation with 12 leads ECG and Holter ECG in people with Embolic Stroke of Undetermined Source, run by Hospices Civils de Lyon at 3 sites 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 31 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Philippe CHEVALIER, Pr (4.72.35.70.27 ext. +33, philippe.chevalier@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean flow velocities in the left atrium (time frame: One Day). 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 21 Sep 2023.