Status:
UNKNOWN
Identification of New Markers of Atrial Myopathy in Patients With Embolic Stroke of Undetermined Source (ESUS) From MRI 4D Data
Lead Sponsor:
Hospices Civils de Lyon
Conditions:
Embolic Stroke of Undetermined Source
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2024
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04717843
Start Date
March 1 2021
End Date
September 1 2024
Last Update
September 21 2023
Active Locations (3)
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1
Service d'urgences neuro-vasculaires, service de neurologie vasculaire Hôpital neurologique Pierre Wertheimer
Bron, France, 69677
2
Service Imagerie médicale Hôpital neurologique Pierre Wertheimer
Bron, France, 69677
3
Service rythmologie, Hôpital cardiologique Louis Pradel
Bron, France, 69677