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

NCT04717843 | Unknown

• 1 other identifier: 69HCL20_0790
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 3

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.

Conditions

Embolic Stroke of Undetermined Source

Keywords

Atrial Myopathy; Atrial Fibrillation; ESUS; MRI; blood velocity; left atrium

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Maximal flow velocities in the left atrium

  One Day

• Left atrium stasis

  One Day

• Vortex size

  One Day

• Left atrium volume

  One Day

Study Arms (4)

Patients with embolic strokes of undetermined source.

EXPERIMENTAL

Patients over 18 years old, with embolic strokes of undetermined source, fulfilling the TOAST criteria. The intervention consists of a 4D Flow MRI.

Other: 4D Flow MRI

Patients with non-paroxysmal AF.

EXPERIMENTAL

Patients over 18 years old, with non-paroxysmal AF. The intervention consists of a 4D Flow MRI.

Other: 4D Flow MRI

Heathy volunteers

ACTIVE COMPARATOR

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.

Other: 4D Flow MRI; Other: Medical consultation with 12 leads ECG; Other: Holter ECG; Other: Trans thoracic echocardiography; Biological: Blood sample

ESUS and non-paroxysmal AF patients with cardiac MRI

EXPERIMENTAL

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.

Other: Standard MRI

Interventions

4D Flow MRI OTHER

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; Patients with embolic strokes of undetermined source.; Patients with non-paroxysmal AF.

Medical consultation with 12 leads ECG OTHER

Collection of medical history, treatment, physical examination and realization of a 12 leads ECG.

Heathy volunteers

Holter ECG OTHER

48 hours ECG recording

Heathy volunteers

Trans thoracic echocardiography OTHER

Trans thoracic echocardiography with standard measures performes in the core lab.

Heathy volunteers

Blood sample BIOLOGICAL

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

Heathy volunteers

Standard MRI OTHER

Acquisitions of MR imagining

ESUS and non-paroxysmal AF patients with cardiac MRI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• Age ≥ 45 years old

You may not qualify if:

• 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
• 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
• 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)

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (3)

Service d'urgences neuro-vasculaires, service de neurologie vasculaire Hôpital neurologique Pierre Wertheimer

Bron, 69677, France

NOT YET RECRUITING

Service Imagerie médicale Hôpital neurologique Pierre Wertheimer

Bron, 69677, France

NOT YET RECRUITING

Service rythmologie, Hôpital cardiologique Louis Pradel

Bron, 69677, France

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Philippe CHEVALIER, Pr

  Chief of the Arrhythmia Unit at the Academic Hospital of Lyon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Philippe CHEVALIER, Pr

CONTACT

4.72.35.70.27; philippe.chevalier@chu-lyon.fr

Sihem BEN AOUICHA, PhD

CONTACT

4 72 35 69 42; Sihem.ben-aouicha@chu-lyon.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2021
• First Posted: January 22, 2021
• Study Start: March 1, 2021
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: September 21, 2023

Record last verified: 2023-06

Locations

FR (3)