Identification of New Markers of Atrial Myopathy in Patients With Embolic Stroke of Undetermined Source (ESUS) From MRI 4D Data
NCT ID: NCT04717843
Last Updated: 2023-09-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
40 participants
INTERVENTIONAL
2021-03-01
2024-09-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Patients with embolic strokes of undetermined source.
Patients over 18 years old, with embolic strokes of undetermined source, fulfilling the TOAST criteria. The intervention consists of a 4D Flow MRI.
4D 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.
Patients with non-paroxysmal AF.
Patients over 18 years old, with non-paroxysmal AF. The intervention consists of a 4D Flow MRI.
4D 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.
Heathy volunteers
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.
4D 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.
Medical consultation with 12 leads ECG
Collection of medical history, treatment, physical examination and realization of a 12 leads ECG.
Holter ECG
48 hours ECG recording
Trans thoracic echocardiography
Trans thoracic echocardiography with standard measures performes in the core lab.
Blood sample
Blood sample in a peripheral vein, send to medical laboratory to dosage of NT pro BNP and troponin serum level.
ESUS and non-paroxysmal AF patients with cardiac MRI
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.
Standard MRI
Acquisitions of MR imagining
Interventions
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4D 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.
Medical consultation with 12 leads ECG
Collection of medical history, treatment, physical examination and realization of a 12 leads ECG.
Holter ECG
48 hours ECG recording
Trans thoracic echocardiography
Trans thoracic echocardiography with standard measures performes in the core lab.
Blood sample
Blood sample in a peripheral vein, send to medical laboratory to dosage of NT pro BNP and troponin serum level.
Standard MRI
Acquisitions of MR imagining
Eligibility Criteria
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Inclusion Criteria
* 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)
* 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
* 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.
18 Years
ALL
Yes
Sponsors
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Hospices Civils de Lyon
OTHER
Responsible Party
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Principal Investigators
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Philippe CHEVALIER, Pr
Role: PRINCIPAL_INVESTIGATOR
Chief of the Arrhythmia Unit at the Academic Hospital of Lyon
Locations
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Service d'urgences neuro-vasculaires, service de neurologie vasculaire Hôpital neurologique Pierre Wertheimer
Bron, , France
Service Imagerie médicale Hôpital neurologique Pierre Wertheimer
Bron, , France
Service rythmologie, Hôpital cardiologique Louis Pradel
Bron, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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69HCL20_0790
Identifier Type: -
Identifier Source: org_study_id
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