Identifying new markers of atrial myopathy in patients with unexplained strokes
Identification of New Markers of Atrial Myopathy in Patients With Embolic Stroke of Undetermined Source (ESUS) From MRI 4D Data
This study is trying to find new signs of atrial myopathy in patients with unexplained strokes to help improve their care and prevent future strokes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospices Civils de Lyon Academic / other |
| Locations | 3 sites (Bron and 2 other locations) |
| Trial ID | NCT04717843 on ClinicalTrials.gov |
What this trial studies
This study aims to identify new markers of atrial myopathy, which is believed to contribute to many cases of embolic stroke of undetermined source (ESUS). Utilizing a multi-parametric approach, the research will incorporate various diagnostic methods including 4D flow MRI, ECG, echocardiography, and blood samples. By better defining atrial myopathy, the study seeks to improve patient management and potentially guide anticoagulation therapy to prevent future strokes. The study will involve patients diagnosed with ESUS and those with documented non-paroxysmal atrial fibrillation.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who have experienced an ischemic embolic stroke of undetermined source or have documented non-paroxysmal atrial fibrillation.
Not a fit: Patients with major cardio-embolic sources or other specific causes for their stroke may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved identification and management of atrial myopathy, potentially reducing the risk of recurrent strokes in affected patients.
How similar studies have performed: While the approach of identifying atrial myopathy markers is innovative, similar studies have shown promise in understanding the relationship between atrial conditions and stroke risk.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Bron and 2 other locations
- Service d'urgences neuro-vasculaires, service de neurologie vasculaire Hôpital neurologique Pierre Wertheimer — Bron, France (Not_yet_recruiting)
- Service Imagerie médicale Hôpital neurologique Pierre Wertheimer — Bron, France (Not_yet_recruiting)
- Service rythmologie, Hôpital cardiologique Louis Pradel — Bron, France (Recruiting)
Study contacts
- Principal investigator: Philippe CHEVALIER, Pr — Chief of the Arrhythmia Unit at the Academic Hospital of Lyon
- Study coordinator: Philippe CHEVALIER, Pr
- Email: philippe.chevalier@chu-lyon.fr
- Phone: 4.72.35.70.27
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.