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Brain MRI in Stroke Patients With Intracardiac Thrombus (BRAIN IRM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04456309
Recruitment Status : Recruiting
First Posted : July 2, 2020
Last Update Posted : July 2, 2020
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes

Brief Summary:
In earlier reports, infarction of cardioembolic origin has been associated with acute lesions involving the cortex, and with multiple acute lesions in single or multiple cerebral circulation territories, and small (most often chronic and asymptomatic) cortical cerebellar infarctions (SCCI). Our aim was to analyse brain MRI characteristics in patients presenting with acute infarction associated with intracardiac thrombus, and to compare them with stroke patients with atrial fibrillation (AF).

Condition or disease Intervention/treatment
Stroke Intracardiac Thrombus Other: No intervention,

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Study Type : Observational
Estimated Enrollment : 63 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Brain MRI Characteristics in Stroke Patients With Intracardiac Thrombus
Actual Study Start Date : May 1, 2020
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Clots

Group/Cohort Intervention/treatment
Atrial fibrillation
stroke Patients with atrial fibrillation
Other: No intervention,
pure observational study

intracardiac thrombus
stroke Patients with intracardiac thrombus
Other: No intervention,
pure observational study




Primary Outcome Measures :
  1. brain MRI diffusion-weighted imaging for the acute symptomatic infarction Both groups [ Time Frame: Day of inclusion (Day 1) ]
    infarction location ((anterior/middle/posterior cerebral artery; brainstem or cerebellum [SCCI or non-SCCI] involvement; anterior, posterior, or mixed anterior-posterior circulation)

  2. brain MRI diffusion-weighted imaging for the acute symptomatic infarction Both groups [ Time Frame: Day of inclusion (Day 1) ]
    presence of multiterritorial infarction (mixed anterior-posterior circulation or bilateral anterior circulation)

  3. brain MRI diffusion-weighted imaging for the acute symptomatic infarction Both groups [ Time Frame: Day of inclusion (Day 1) ]
    number of infarction lesions

  4. brain MRI diffusion-weighted imaging for the acute symptomatic infarction Both groups [ Time Frame: Day of inclusion (Day 1) ]
    the cortical/subcortical/corticosubcortical location of infarction

  5. brain MRI diffusion-weighted imaging for the acute symptomatic infarction Both groups [ Time Frame: Day of inclusion (Day 1) ]
    the size of subcortical lesion (< or >15 mm)

  6. brain MRI diffusion-weighted imaging for the acute symptomatic infarction Both groups [ Time Frame: Day of inclusion (Day 1) ]
    the infarction volume (DWI volume and ASPECT score)

  7. Brain MRI for the group with intracardiac thrombus [ Time Frame: Day of inclusion (Day 1) ]
    Localisation of the thrombus

  8. Brain MRI for the group with intracardiac thrombus [ Time Frame: Day of inclusion (Day 1) ]
    the size of the thrombus

  9. Brain MRI for the group with intracardiac thrombus [ Time Frame: Day of inclusion (Day 1) ]
    The associated echocardiographic abnormalities (dilated atrium of ventricle, ejection fraction, hypokinesia)

  10. Brain MRI for the group with intracardiac thrombus [ Time Frame: Day of inclusion (Day 1) ]
    the presence of associated AF

  11. Brain MRI for the group with intracardiac thrombus [ Time Frame: Day of inclusion (Day 1) ]
    the time interval between the brain MRI performance and the identification of the intracardiac thrombus



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

2 groups of patients :

1 - Stroke patients with atrial fibrillation

2- Stroke patients with intracardiac thrombus

Criteria

Inclusion Criteria:

  • Consecutive patients, recruited and registered in the stroke database between June 2018 and November 2019 of our center (Nîmes University Hospital, France), presenting with acute symptomatic infarction (confirmed by diffusion-weighted MRI) associated with intracardiac thrombus or with with known or newly discovered AF
  • Patients with MRI as part of their diagnostic work-up within one week after symptom onset (including diffusion-weighted imaging, intra- [TOF, gadolinium-enhanced MRA, and/or CTA] and extracranial [gadolinium-enhanced MRA, CTA, and/or duplex ultrasound] vessel imaging, contrast transoesophageal or contrast transthoracic echocardiography, and ≥24h ECG monitoring (acute stroke unit monitoring and/or Holter monitoring)

Exclusion Criteria:

  • opt-out patient

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04456309


Contacts
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Contact: Dimitri RENARD, Dr +33 4 66 68 32 61 dimitri.renard@chu-nimes.fr

Locations
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France
CHU de Nîmes Recruiting
Nîmes, France, 30029
Contact: Dimitri RENARD    +33 4 66 68 32 61    dimitri.renard@chu-nimes.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
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Principal Investigator: Dimitri RENARD CHU de Nîmes
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Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT04456309    
Other Study ID Numbers: LOCAL/2020/DR-02
First Posted: July 2, 2020    Key Record Dates
Last Update Posted: July 2, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire de Nīmes:
brain MRI
Additional relevant MeSH terms:
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Stroke
Thrombosis
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Embolism and Thrombosis