Identification of New Markers of Atrial Myopathy in Patients With Embolic Stroke of Undetermined Source (ESUS) From MRI 4D Data

Not Applicable

Recruiting

• Conditions: Embolic Stroke of Undetermined Source
• Interventions: Other: Standard MRI; Other: 4D Flow MRI; Other: Medical consultation with 12 leads ECG; Other: Holter ECG; Other: Trans thoracic echocardiography; Biological: Blood sample

• Registration Number: NCT04717843
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-15
• Study First Submitted QC: 2021-01-20
• Study First Posted: 2021-01-22
• Study Start: 2021-03-01
• Status Verified: 2023-06
• Last Update Submitted: 2023-09-20
• Last Update Posted: 2023-09-21
• Primary Completion: 2024-09-01
• Study Completion: 2024-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Heathy volunteers	Blood sample	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.
Heathy volunteers	Holter ECG	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.
ESUS and non-paroxysmal AF patients with cardiac MRI	Standard 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.
Patients with embolic strokes of undetermined source.	4D Flow MRI	Patients over 18 years old, with embolic strokes of undetermined source, fulfilling the TOAST criteria. The intervention consists of a 4D Flow MRI.
Patients with non-paroxysmal AF.	4D Flow MRI	Patients over 18 years old, with non-paroxysmal AF. The intervention consists of a 4D Flow MRI.
Heathy volunteers	4D Flow MRI	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.
Heathy volunteers	Medical consultation with 12 leads ECG	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.
Heathy volunteers	Trans thoracic echocardiography	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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
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.

Trial Locations

Locations (3)

Service d'urgences neuro-vasculaires, service de neurologie vasculaire Hôpital neurologique Pierre Wertheimer; 🇫🇷 Bron, France

Service rythmologie, Hôpital cardiologique Louis Pradel; 🇫🇷 Bron, France

Service Imagerie médicale Hôpital neurologique Pierre Wertheimer; 🇫🇷 Bron, France