<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04456309</url>
  </required_header>
  <id_info>
    <org_study_id>LOCAL/2020/DR-02</org_study_id>
    <nct_id>NCT04456309</nct_id>
  </id_info>
  <brief_title>Brain MRI in Stroke Patients With Intracardiac Thrombus</brief_title>
  <acronym>BRAIN IRM</acronym>
  <official_title>Brain MRI Characteristics in Stroke Patients With Intracardiac Thrombus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire de Nīmes</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire de Nīmes</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Acute infarction patterns have been described in cardioembolic stroke, mainly with atrial&#xD;
      fibrillation (AF) or patent foramen ovale. We aimed to analyse acute infarction MRI&#xD;
      characteristics in stroke patients with intracardiac thrombus (ICT) compared with stroke&#xD;
      patients with AF.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2020</start_date>
  <completion_date type="Actual">November 15, 2020</completion_date>
  <primary_completion_date type="Actual">November 15, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Brain MRI characteristics</measure>
    <time_frame>Day of inclusion (Day 1)</time_frame>
    <description>infarction location (anterior/middle/posterior cerebral artery territory; anterior/posterior/mixed anterior-posterior circulation; multiterritorial infarction; brainstem; cerebellum; small cortical cerebellar infarctions [SCCI] or non-SCCI; cortical/subcortical/corticosubcortical)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Brain MRI characteristics</measure>
    <time_frame>Day of inclusion (Day 1)</time_frame>
    <description>lesion number</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Brain MRI characteristics</measure>
    <time_frame>Day of inclusion (Day 1)</time_frame>
    <description>subcortical lesion size (&gt;&lt;15 mm)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Brain MRI characteristics</measure>
    <time_frame>Day of inclusion (Day 1)</time_frame>
    <description>total infarction volume.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">122</enrollment>
  <condition>Stroke</condition>
  <condition>Intracardiac Thrombus</condition>
  <arm_group>
    <arm_group_label>Atrial fibrillation</arm_group_label>
    <description>stroke patients with atrial fibrillation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intracardiac thrombus</arm_group_label>
    <description>stroke patients with intracardiac thrombus</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No intervention,</intervention_name>
    <description>pure observational study</description>
    <arm_group_label>Atrial fibrillation</arm_group_label>
    <arm_group_label>Intracardiac thrombus</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        2 groups of patients :&#xD;
&#xD;
        1 - Stroke patients with atrial fibrillation&#xD;
&#xD;
        2- Stroke patients with intracardiac thrombus&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  consecutive patients presenting with acute symptomatic cardioembolic infarction&#xD;
             associated with ICT, recruited and registered in the stroke database between June 2018&#xD;
             and November 2019 of our centre (Nîmes University Hospital, France). These patients&#xD;
             were compared with consecutive cardioembolic stroke patients with known or newly&#xD;
             discovered AF (in the absence of ICT on echocardiography), recruited during the same&#xD;
             time period.&#xD;
&#xD;
          -  Brain MRI (including diffusion-weighted imaging [DWI]) performed within one week of&#xD;
             symptom onset; complete etiological work-up including intracranial (time-of-flight&#xD;
             [TOF], gadolinium-enhanced magnetic resonance angiography [MRA], or computed&#xD;
             tomographic angiography [CTA]) and extracranial (gadolinium-enhanced MRA, CTA, or&#xD;
             duplex ultrasound) vessel imaging; transthoracic or transoesophageal echocardiography;&#xD;
             and ≥24h ECG monitoring (acute stroke unit monitoring and/or Holter ECG monitoring).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  opt-out patient&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dimitri RENARD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre Hospitalier Universitaire de Nīmes</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU de Nîmes</name>
      <address>
        <city>Nîmes</city>
        <zip>30029</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>June 22, 2020</study_first_submitted>
  <study_first_submitted_qc>June 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 2, 2020</study_first_posted>
  <last_update_submitted>November 18, 2020</last_update_submitted>
  <last_update_submitted_qc>November 18, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 20, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>brain MRI</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Thrombosis</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04456309
org study id: LOCAL/2020/DR-02
nct id: NCT04456309
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Acute infarction patterns have been described in cardioembolic stroke, mainly with atrial
      fibrillation (AF) or patent foramen ovale. We aimed to analyse acute infarction MRI
      characteristics in stroke patients with intracardiac thrombus (ICT) compared with stroke
      patients with AF.
observational model: Cohort
time perspective: Retrospective
measure: Brain MRI characteristics
time frame: Day of inclusion (Day 1)
description: infarction location (anterior/middle/posterior cerebral artery territory; anterior/posterior/mixed anterior-posterior circulation; multiterritorial infarction; brainstem; cerebellum; small cortical cerebellar infarctions [SCCI] or non-SCCI; cortical/subcortical/corticosubcortical)
measure: Brain MRI characteristics
time frame: Day of inclusion (Day 1)
description: lesion number
measure: Brain MRI characteristics
time frame: Day of inclusion (Day 1)
description: subcortical lesion size (><15 mm)
measure: Brain MRI characteristics
time frame: Day of inclusion (Day 1)
description: total infarction volume.
arm group label: Atrial fibrillation
description: stroke patients with atrial fibrillation
arm group label: Intracardiac thrombus
description: stroke patients with intracardiac thrombus
intervention type: Other
intervention name: No intervention,
description: pure observational study
arm group label: Atrial fibrillation
arm group label: Intracardiac thrombus
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Dimitri RENARD
role: Principal Investigator
affiliation: Centre Hospitalier Universitaire de Nīmes
facility: 
country: France
responsible party type: Sponsor
mesh term: Stroke
mesh term: Thrombosis