Embolic Stroke of Undetermined Source
Conditions
Keywords
Atrial Myopathy, Atrial Fibrillation, ESUS, MRI, blood velocity, left atrium
Brief 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. 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.
Interventions
OTHER4D Flow MRI
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.
OTHERMedical consultation with 12 leads ECG
Collection of medical history, treatment, physical examination and realization of a 12 leads ECG.
OTHERHolter ECG
48 hours ECG recording
Trans thoracic echocardiography with standard measures performes in the core lab.
BIOLOGICALBlood sample
Blood sample in a peripheral vein, send to medical laboratory to dosage of NT pro BNP and troponin serum level.
OTHERStandard MRI
Acquisitions of MR imagining
Sponsors
Hospices Civils de Lyon
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
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). * 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
Exclusion criteria
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) * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean flow velocities in the left atrium | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximal flow velocities in the left atrium | 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. Local peak velocity will be obtained by averaging 5 percent of all maximum values. |
| Left atrium stasis | 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. Local peak velocity will be obtained by averaging 5 percent of all maximum values |
| Vortex size | One Day | Vortices in the isolated LA chamber were detectedusing the Lambda2 (λ2) method, which is an objective and widelyaccepted method to identify 3D vortice. |
| Left atrium volume | One Day | Extracted from 3D MR reconstruction, expressed in mL/m2 of body surface area. |
Countries
France
Contacts
Primary ContactPhilippe CHEVALIER, Pr
Backup ContactSihem BEN AOUICHA, PhD
Outcome results
None listed