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

Embolic Stroke of Undetermined Source Clinical Trial

— IRM 4D-AVC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04717843
• Other study ID #: 69HCL20_0790
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: September 1, 2024

Study information

• Verified date: June 2023
• Source: Hospices Civils de Lyon
• Contact: Philippe CHEVALIER, Pr
• Phone: 4.72.35.70.27
• Email: philippe.chevalier[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: September 1, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Embolic Stroke
• Embolic Stroke of Undetermined Source
• Muscular Diseases
• Stroke

Intervention

Other:
• 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.

Biological:
• Blood sample
Blood sample in a peripheral vein, send to medical laboratory to dosage of NT pro BNP and troponin serum level.

Other:
• Standard MRI
Acquisitions of MR imagining

Locations

Country	Name	City	State
France	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

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean flow velocities in the left atrium	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	One Day
Secondary	Maximal flow velocities in the left atrium	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.	One Day
Secondary	Left atrium stasis	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	One Day
Secondary	Vortex size	Vortices in the isolated LA chamber were detectedusing the Lambda2 (?2) method, which is an objective and widelyaccepted method to identify 3D vortice.	One Day
Secondary	Left atrium volume	Extracted from 3D MR reconstruction, expressed in mL/m2 of body surface area.	One Day