<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/NCT04417881</url>
  </required_header>
  <id_info>
    <org_study_id>7880</org_study_id>
    <nct_id>NCT04417881</nct_id>
  </id_info>
  <brief_title>EVALUER L'IMPACT PREDICTIF DU SCORE MEESSI POUR LA STRATIFICATION DU RISQUE DES PATIENTS ADMIS POUR INSUFFISANCE CARDIAQUE AIGUE DANS LES STRUCTURES D'URGENCES</brief_title>
  <acronym>ICA-MEESSI</acronym>
  <official_title>EVALUER L'IMPACT PREDICTIF DU SCORE MEESSI POUR LA STRATIFICATION DU RISQUE DES PATIENTS ADMIS POUR INSUFFISANCE CARDIAQUE AIGUE DANS LES STRUCTURES D'URGENCES (ICA-MEESSI)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Strasbourg, France</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Strasbourg, France</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>
      Our primary purpose is to assess MEESSI score in predicting mortality and readmission of&#xD;
      patients managed for acute heart failure (AHF) in Emergency Department.&#xD;
&#xD;
      European Society of Cardiology recommend risk stratification for patients with AHF. MEESSI&#xD;
      score is not prospectively validated out of Spain.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 19, 2020</start_date>
  <completion_date type="Actual">June 23, 2021</completion_date>
  <primary_completion_date type="Actual">December 19, 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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>MEESSI score</measure>
    <time_frame>30 days</time_frame>
    <description>Tscore to predict the patient's future in the month following management for ED ICA. That is to say the number of days alive outside the hospital in the month following an ICA episode.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Re-admission rate</measure>
    <time_frame>30 days</time_frame>
    <description>30-day re-admission rate compared between the 4 risk categories defined by the MEESSI score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality rate</measure>
    <time_frame>30 days</time_frame>
    <description>Mortality rate at 30 days compared between the 4 risk categories defined by the MEESSI score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sensitivity</measure>
    <time_frame>30 days</time_frame>
    <description>Sensitivity, specificity and ROC curve of the MEESSI score in relation to the composite criterion according to the 4 risk categories</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">367</enrollment>
  <condition>Acurate Heart Failure</condition>
  <arm_group>
    <arm_group_label>patients with acurate heart failure</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>MEESSI score</intervention_name>
    <description>MEESSI score in predicting mortality and readmission of patients managed for acute heart failure (AHF) in Emergency Department.</description>
    <arm_group_label>patients with acurate heart failure</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patient admitted to emergencies with suspicion of ICA&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Major patient&#xD;
&#xD;
          -  Patient admitted to emergencies with suspicion of ICA according to the clinical&#xD;
             intuition of the emergency doctor after interrogation, clinical examination, biology&#xD;
             and imaging&#xD;
&#xD;
          -  Patient with health insurance&#xD;
&#xD;
          -  Subject who accept to participate in the research&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient who refuse to participate in the study&#xD;
&#xD;
          -  Patient with coronary syndrome with ST segment elevation&#xD;
&#xD;
          -  Other diagnosis of dyspnea&#xD;
&#xD;
          -  Persons deprived of their freedom or under the protection of justice&#xD;
&#xD;
          -  Persons under guardianship or curatorship&#xD;
&#xD;
          -  Impossibility of giving the patient informed information&#xD;
&#xD;
          -  Pregnant woman&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hôpital Jean Minjoz</name>
      <address>
        <city>Besançon</city>
        <zip>25030</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Jean Rougié</name>
      <address>
        <city>Cahors</city>
        <zip>46005</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpitaux Civils de Colmar</name>
      <address>
        <city>Colmar</city>
        <zip>68000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH Haguenau</name>
      <address>
        <city>Haguenau</city>
        <zip>67500</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Forez</name>
      <address>
        <city>Montbrison</city>
        <zip>42605</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Montpellier</name>
      <address>
        <city>Montpellier</city>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Nancy</name>
      <address>
        <city>Nancy</city>
        <zip>54035</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Pitié Salpetrière</name>
      <address>
        <city>Paris</city>
        <zip>75013</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Reims</name>
      <address>
        <city>Reims</city>
        <zip>51100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH Remiremont</name>
      <address>
        <city>Remiremont</city>
        <zip>88200</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Robert Pax</name>
      <address>
        <city>Sarreguemines</city>
        <zip>57200</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Les Hôpitaux Universitaires de Strasbourg</name>
      <address>
        <city>Strasbourg</city>
        <zip>67091</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Toulouse</name>
      <address>
        <city>Toulouse</city>
        <zip>31300</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Nord Franche Comté</name>
      <address>
        <city>Trévenans</city>
        <zip>90400</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>June 2, 2020</study_first_submitted>
  <study_first_submitted_qc>June 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 5, 2020</study_first_posted>
  <last_update_submitted>October 1, 2021</last_update_submitted>
  <last_update_submitted_qc>October 1, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 8, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>caring</keyword>
  <keyword>emergency</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04417881
org study id: 7880
nct id: NCT04417881
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Our primary purpose is to assess MEESSI score in predicting mortality and readmission of
      patients managed for acute heart failure (AHF) in Emergency Department.

      European Society of Cardiology recommend risk stratification for patients with AHF. MEESSI
      score is not prospectively validated out of Spain.
observational model: Cohort
time perspective: Prospective
measure: MEESSI score
time frame: 30 days
description: Tscore to predict the patient's future in the month following management for ED ICA. That is to say the number of days alive outside the hospital in the month following an ICA episode.
measure: Re-admission rate
time frame: 30 days
description: 30-day re-admission rate compared between the 4 risk categories defined by the MEESSI score
measure: Mortality rate
time frame: 30 days
description: Mortality rate at 30 days compared between the 4 risk categories defined by the MEESSI score
measure: Sensitivity
time frame: 30 days
description: Sensitivity, specificity and ROC curve of the MEESSI score in relation to the composite criterion according to the 4 risk categories
arm group label: patients with acurate heart failure
intervention type: Other
intervention name: MEESSI score
description: MEESSI score in predicting mortality and readmission of patients managed for acute heart failure (AHF) in Emergency Department.
arm group label: patients with acurate heart failure
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
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country: France
responsible party type: Sponsor
mesh term: Heart Failure
sharing ipd: Undecided