<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/NCT03303820</url>
  </required_header>
  <id_info>
    <org_study_id>ADIT</org_study_id>
    <nct_id>NCT03303820</nct_id>
  </id_info>
  <brief_title>Analysis of the Impact of the Undernutrition on the Cerebral Infarct in Thrombolized Patients</brief_title>
  <official_title>Analysis of the Impact of the Undernutrition on the Cerebral Infarct in Thrombolized Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fondation Hôpital Saint-Joseph</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fondation Hôpital Saint-Joseph</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>
      Many clinical trials show that 30 to 50 % of the hospitalized patients are undernourished in&#xD;
      various degrees. This prevalence didn't change since 15-20 years The fact is that the present&#xD;
      undernutrition in the admission deteriorates during the hospitalization.&#xD;
&#xD;
      Besides, the cerebral vascular accident (AVC) complicates the first days, in at least 50 % of&#xD;
      the cases, the disorders of the gulp, which are a risk factor of acquired undernutrition. The&#xD;
      nutrition holds an important place in the therapeutic coverage of the AVC. Nevertheless, the&#xD;
      link between the undernutrition the entrance and the evolution of the AVC is at the moment&#xD;
      only little known. The purpose is to study the impact of the undernutrition in the entrance&#xD;
      to the hospital (undernutrition previous to the AVC), on the gravity and the evolution&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 27, 2016</start_date>
  <completion_date type="Actual">August 31, 2017</completion_date>
  <primary_completion_date type="Actual">May 27, 2017</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>Rankin score</measure>
    <time_frame>Day 1; last day of hospitalisation</time_frame>
    <description>measurement of Rankin score at the entrance and at the end of hospitalisation</description>
  </primary_outcome>
  <enrollment type="Actual">73</enrollment>
  <condition>Thrombosis</condition>
  <eligibility>
    <study_pop>
      <textblock>
        patient admitted in hospital for vascular cerebral accident in 2015 with thrombolytic&#xD;
        treatment&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patient admitted in hospital for vascular cerebral accident in 2015&#xD;
&#xD;
          -  thrombolytic treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  no thrombolytic treatment&#xD;
&#xD;
          -  transcient ischaemic attack&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>ZUBER Mathieu, Professor</last_name>
    <role>Study Director</role>
    <affiliation>GHPSJ</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Groupe Hospitalier Paris Saint Joseph</name>
      <address>
        <city>Paris</city>
        <state>Ile-de-France</state>
        <zip>75014</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>October 2, 2017</study_first_submitted>
  <study_first_submitted_qc>October 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 6, 2017</study_first_posted>
  <last_update_submitted>October 5, 2017</last_update_submitted>
  <last_update_submitted_qc>October 5, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cerebral Infarction</mesh_term>
    <mesh_term>Thrombosis</mesh_term>
    <mesh_term>Malnutrition</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/NCT03303820
org study id: ADIT
nct id: NCT03303820
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Many clinical trials show that 30 to 50 % of the hospitalized patients are undernourished in
      various degrees. This prevalence didn't change since 15-20 years The fact is that the present
      undernutrition in the admission deteriorates during the hospitalization.

      Besides, the cerebral vascular accident (AVC) complicates the first days, in at least 50 % of
      the cases, the disorders of the gulp, which are a risk factor of acquired undernutrition. The
      nutrition holds an important place in the therapeutic coverage of the AVC. Nevertheless, the
      link between the undernutrition the entrance and the evolution of the AVC is at the moment
      only little known. The purpose is to study the impact of the undernutrition in the entrance
      to the hospital (undernutrition previous to the AVC), on the gravity and the evolution
observational model: Cohort
time perspective: Retrospective
measure: Rankin score
time frame: Day 1; last day of hospitalisation
description: measurement of Rankin score at the entrance and at the end of hospitalisation
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: ZUBER Mathieu, Professor
role: Study Director
affiliation: GHPSJ
facility: 
country: France
responsible party type: Sponsor
mesh term: Cerebral Infarction
mesh term: Thrombosis
mesh term: Malnutrition