<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/NCT02252900</url>
  </required_header>
  <id_info>
    <org_study_id>P120901</org_study_id>
    <secondary_id>CRC12019</secondary_id>
    <nct_id>NCT02252900</nct_id>
  </id_info>
  <brief_title>Long-term Clinico-radiological Evolution of Patients With Brain Lesions During Infectious Endocarditis</brief_title>
  <acronym>POST-IMAGE</acronym>
  <official_title>Long-term Clinico-radiological Evolution of Patients With Symptomatic and Asymptomatic Brain Lesions During Infectious Endocarditis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique - Hôpitaux de Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique - Hôpitaux de Paris</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Primary objective: To describe the evolution of cerebral lesions in IE patients (number of&#xD;
      patients with abnormal cerebral MRI in acute phase of IE and during follow-up).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Introduction:&#xD;
&#xD;
      Infectious endocarditis (IE) is a rare disease (1500 cases per year in France) with a poor&#xD;
      prognosis (20 % of mortality). Neurological complications participate in the initial&#xD;
      morbimortality but their long-term impact is poorly known. The acute neurological&#xD;
      complications are symptomatic in approximately a quarter of patients. Neurological lesions&#xD;
      are frequently observed using systematic cerebral imaging. In the IMAGE study, systematic&#xD;
      cerebral MRI in 130 patients performed during the acute phase of IE allowed found cerebral&#xD;
      lesion in 82 % of the patients and in 79 % of patients without neurological symptoms. The&#xD;
      evolution of cerebral lesion, including brain micro-bleedings and their impact prognosis are&#xD;
      not known.&#xD;
&#xD;
      Hypothesis: Cerebral lesions detected by MRI during the acute phase of infectious&#xD;
      endocarditis may involve and may have an impact on functional prognosis.&#xD;
&#xD;
      Primary objective: To describe the evolution of cerebral lesions in IE patients (comparing&#xD;
      the proportion of patients with abnormal cerebral MRI in acute phase of IE and during&#xD;
      follow-up).&#xD;
&#xD;
      Secondary objectives:&#xD;
&#xD;
        -  To compare frequency of different brain damages in acute phase of IE and during&#xD;
           follow-up.&#xD;
&#xD;
        -  To analyse the relationship between functional and cognitive status and cerebral&#xD;
           lesions.&#xD;
&#xD;
        -  To analyse the relationship between initial and follow-up cerebral lesions and initials&#xD;
           characteristics (microorganisms, anticoagulation, echocardiographic characteristics,&#xD;
           valve replacement surgery, type of valvular substitute, mycotic aneurysm embolization)&#xD;
&#xD;
        -  To collect plasma during follow-up of IE&#xD;
&#xD;
        -  To compare patient characteristics between patients who accept the functional&#xD;
           exploration and those who patient refuse&#xD;
&#xD;
        -  To describe oral health and oral condition&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>December 2013</start_date>
  <completion_date type="Anticipated">March 2018</completion_date>
  <primary_completion_date type="Anticipated">December 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Comparison of the proportion of patients with abnormal cerebral MRI (ischemic or haemorrhagic lesion, infection and cerebral aneurysm) detected at the initial evaluation during the IE acute phase and at the follow-up visit</measure>
    <time_frame>1 day</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rankin scale</measure>
    <time_frame>1 day</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Karnofsky scale</measure>
    <time_frame>1 day</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neuropsychologic tests to assess cognitive, executive, language and memory functions (including MMS, BREF, Trail making test, Wisconsin card sorting test, STROOP)</measure>
    <time_frame>1 day</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IQCODE</measure>
    <time_frame>1 day</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SF 36</measure>
    <time_frame>1 day</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>WhOQOL</measure>
    <time_frame>1 day</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CES-D scale</measure>
    <time_frame>1 day</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">130</enrollment>
  <condition>Infectious Endocarditis</condition>
  <arm_group>
    <arm_group_label>cerebral MRI during follow-up of IE</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All patients will undergo the diagnostic test specific to the study (Magnetic resonance imaging)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Magnetic resonance imaging</intervention_name>
    <description>All patients will undergo the diagnostic test specific to the study</description>
    <arm_group_label>cerebral MRI during follow-up of IE</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  History of Infective endocarditis treated in Bichat Claude Bernard hospital&#xD;
&#xD;
          -  Cerebral MRI performed during the acute phase of endocarditis&#xD;
&#xD;
          -  Resident in Metropolitan France&#xD;
&#xD;
          -  18 years old or more&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Refusal to participate&#xD;
&#xD;
          -  Contra indication to MRI scan&#xD;
&#xD;
          -  History of allergy to gadolinium&#xD;
&#xD;
          -  Pregnancy or lactating female&#xD;
&#xD;
          -  Lack of Social Security or CMU (recipient or beneficiary)&#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>Bernard IUNG, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assistance Publique - Hôpitaux de Paris</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Bernard IUNG, Professor</last_name>
    <phone>00331 40 25 67 60</phone>
    <email>bernard.iung@bch.aphp.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Xavier DUVAL, Professor</last_name>
    <phone>00331 40 25 71 48</phone>
    <email>xavier.duval@bch.aph.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Groupe Hospitalier Bichat - Claude Bernard</name>
      <address>
        <city>Paris</city>
        <zip>75018</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Bernard IUNG, Professor</last_name>
      <phone>00331 40 25 67 60</phone>
      <email>bernard.iung@bch.aphp.fr</email>
    </contact>
    <contact_backup>
      <last_name>Xavier DUVAL, Professor</last_name>
      <phone>00331 40 25 67 76</phone>
      <email>xavier.duval@bch.aph.fr</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>May 2016</verification_date>
  <study_first_submitted>December 19, 2013</study_first_submitted>
  <study_first_submitted_qc>September 26, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 30, 2014</study_first_posted>
  <last_update_submitted>May 9, 2016</last_update_submitted>
  <last_update_submitted_qc>May 9, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 10, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Brain damages</keyword>
  <keyword>MRI</keyword>
  <keyword>infectious endocarditis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Infections</mesh_term>
    <mesh_term>Endocarditis, Subacute Bacterial</mesh_term>
    <mesh_term>Endocarditis</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/NCT02252900
org study id: P120901
secondary id: CRC12019
nct id: NCT02252900
lead sponsor: 
has dmc: No
Primary objective: To describe the evolution of cerebral lesions in IE patients (number of
      patients with abnormal cerebral MRI in acute phase of IE and during follow-up).
Introduction:

      Infectious endocarditis (IE) is a rare disease (1500 cases per year in France) with a poor
      prognosis (20 % of mortality). Neurological complications participate in the initial
      morbimortality but their long-term impact is poorly known. The acute neurological
      complications are symptomatic in approximately a quarter of patients. Neurological lesions
      are frequently observed using systematic cerebral imaging. In the IMAGE study, systematic
      cerebral MRI in 130 patients performed during the acute phase of IE allowed found cerebral
      lesion in 82 % of the patients and in 79 % of patients without neurological symptoms. The
      evolution of cerebral lesion, including brain micro-bleedings and their impact prognosis are
      not known.

      Hypothesis: Cerebral lesions detected by MRI during the acute phase of infectious
      endocarditis may involve and may have an impact on functional prognosis.

      Primary objective: To describe the evolution of cerebral lesions in IE patients (comparing
      the proportion of patients with abnormal cerebral MRI in acute phase of IE and during
      follow-up).

      Secondary objectives:

        -  To compare frequency of different brain damages in acute phase of IE and during
           follow-up.

        -  To analyse the relationship between functional and cognitive status and cerebral
           lesions.

        -  To analyse the relationship between initial and follow-up cerebral lesions and initials
           characteristics (microorganisms, anticoagulation, echocardiographic characteristics,
           valve replacement surgery, type of valvular substitute, mycotic aneurysm embolization)

        -  To collect plasma during follow-up of IE

        -  To compare patient characteristics between patients who accept the functional
           exploration and those who patient refuse

        -  To describe oral health and oral condition
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Comparison of the proportion of patients with abnormal cerebral MRI (ischemic or haemorrhagic lesion, infection and cerebral aneurysm) detected at the initial evaluation during the IE acute phase and at the follow-up visit
time frame: 1 day
measure: Rankin scale
time frame: 1 day
measure: Karnofsky scale
time frame: 1 day
measure: Neuropsychologic tests to assess cognitive, executive, language and memory functions (including MMS, BREF, Trail making test, Wisconsin card sorting test, STROOP)
time frame: 1 day
measure: IQCODE
time frame: 1 day
measure: SF 36
time frame: 1 day
measure: WhOQOL
time frame: 1 day
measure: CES-D scale
time frame: 1 day
arm group label: cerebral MRI during follow-up of IE
arm group type: Experimental
description: All patients will undergo the diagnostic test specific to the study (Magnetic resonance imaging)
intervention type: Other
intervention name: Magnetic resonance imaging
description: All patients will undergo the diagnostic test specific to the study
arm group label: cerebral MRI during follow-up of IE
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Bernard IUNG, Professor
role: Principal Investigator
affiliation: Assistance Publique - Hôpitaux de Paris
last name: Bernard IUNG, Professor
phone: 00331 40 25 67 60
email: bernard.iung@bch.aphp.fr
last name: Xavier DUVAL, Professor
phone: 00331 40 25 71 48
email: xavier.duval@bch.aph.fr
facility: 
status: Recruiting
contact: 
contact backup: 
country: France
responsible party type: Sponsor
mesh term: Communicable Diseases
mesh term: Infections
mesh term: Endocarditis, Subacute Bacterial
mesh term: Endocarditis