NCT04717843招募中不适用
Identification of New Markers of Atrial Myopathy in Patients With Embolic Stroke of Undetermined Source (ESUS) From MRI 4D Data
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 6
- 主要终点
- Mean flow velocities in the left atrium
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Mean flow velocities in the left atrium
时间窗: 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
次要结局
- Vortex size(One Day)
- Left atrium volume(One Day)
- Left atrium stasis(One Day)
- Maximal flow velocities in the left atrium(One Day)
研究者
研究点 (6)
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