<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/NCT04481126</url>
  </required_header>
  <id_info>
    <org_study_id>APHP201021</org_study_id>
    <nct_id>NCT04481126</nct_id>
  </id_info>
  <brief_title>Acute Renal Insufficiency (ARI) Rate and Predictive Score of ARI in Hospitalized Patients for Acute Coronary Syndrome With ST-segment Elevation Needing Urgent Coronarography</brief_title>
  <acronym>COROAKI</acronym>
  <official_title>Acute Renal Insufficiency (ARI) Rate and Predictive Score of ARI in Hospitalized Patients for Acute Coronary Syndrome With ST-segment Elevation Needing Urgent Coronarography</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of the study aims to evaluate frequence of acute renal insufficiency in&#xD;
      patients with ST-segment elevation who need urgent coronary angiography in Ambroise Paré&#xD;
      hospital.&#xD;
&#xD;
      The secondary objectives are:&#xD;
&#xD;
        -  identify factors of risks associated with the occurrence of acute renal insufficiency&#xD;
           after coronarography.&#xD;
&#xD;
        -  establish a preprocedure score, predicting of acute renal insufficiency after urgent&#xD;
           coronary angiography in patients with ST+ acute coronary syndrome.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 1, 2020</start_date>
  <completion_date type="Anticipated">December 2022</completion_date>
  <primary_completion_date type="Anticipated">December 2022</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>incidence of acute renal failure</measure>
    <time_frame>at baselin and at 48 hours</time_frame>
    <description>Acute renal failure is defined as an increase in plasma creatinine of at least 26.5µmol/l within 48 hours, or an increase in plasma creatinine of at least 1.5 times plasma creatinine within 48hours of hospitalisation</description>
  </primary_outcome>
  <enrollment type="Anticipated">168</enrollment>
  <condition>Acute Renal Insufficiency</condition>
  <condition>Acute Coronary Syndrome</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patient hospitalized in Ambroise Paré hospital in the period between Jan 2017 to Jul 2019,&#xD;
        who have been an urgent coronarography, and have a renal insufficiency needing dialysis.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patient aged ≥ 18 years;&#xD;
&#xD;
          -  evocative symptoms of myocardiac ischemia: typical chest pain; ST-segment elevation&#xD;
             and 1 mm in two consecutive peripheral leads and 2 mm in two consecutive precordial&#xD;
             derivations, or appearance of a bloc of left branch of novo;&#xD;
&#xD;
          -  need urgent coronarography;&#xD;
&#xD;
          -  Covered by french social security scheme included CMU.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  dialysed patient for chronic renal insufficiency;&#xD;
&#xD;
          -  cardio-resporatory arrest;&#xD;
&#xD;
          -  cardiogenic choc state;&#xD;
&#xD;
          -  prior emergency passage to hospital;&#xD;
&#xD;
          -  patient under tutor, gardianship;&#xD;
&#xD;
          -  patient covered by french AME scheme;&#xD;
&#xD;
          -  pregnant women or breastfeeding;&#xD;
&#xD;
          -  all medical, psychological or social situation which should influents the compliance&#xD;
             to protocol according to investigator;&#xD;
&#xD;
          -  patient refusal.&#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>Paul GABARRE, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Nephrology department, Ambroise Paré hospital, APHP</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Eve Vilaine, MD</last_name>
    <role>Study Director</role>
    <affiliation>Nephrology department, Ambroise Paré hospital, APHP</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Paul GABARRE, MD</last_name>
    <phone>+33 (0)1 49 09 56 45</phone>
    <email>paul.gabarre@aphp.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Eve Vilaine, MD</last_name>
    <phone>+33 (0)1 49 09 56 45</phone>
    <email>eve.vilaine@aphp.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Nephrology department, Ambroise Paré hospital, APHP</name>
      <address>
        <city>Boulogne-Billancourt</city>
        <zip>92100</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>July 17, 2020</study_first_submitted>
  <study_first_submitted_qc>July 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 22, 2020</study_first_posted>
  <last_update_submitted>September 27, 2021</last_update_submitted>
  <last_update_submitted_qc>September 27, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 28, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Acute Renal Insufficiency</keyword>
  <keyword>Acute Coronary Syndrome</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Renal Insufficiency</mesh_term>
    <mesh_term>Acute Kidney Injury</mesh_term>
    <mesh_term>Acute Coronary Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04481126
org study id: APHP201021
nct id: NCT04481126
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The primary objective of the study aims to evaluate frequence of acute renal insufficiency in
      patients with ST-segment elevation who need urgent coronary angiography in Ambroise Paré
      hospital.

      The secondary objectives are:

        -  identify factors of risks associated with the occurrence of acute renal insufficiency
           after coronarography.

        -  establish a preprocedure score, predicting of acute renal insufficiency after urgent
           coronary angiography in patients with ST+ acute coronary syndrome.
observational model: Cohort
time perspective: Retrospective
measure: incidence of acute renal failure
time frame: at baselin and at 48 hours
description: Acute renal failure is defined as an increase in plasma creatinine of at least 26.5µmol/l within 48 hours, or an increase in plasma creatinine of at least 1.5 times plasma creatinine within 48hours of hospitalisation
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Paul GABARRE, MD
role: Principal Investigator
affiliation: Nephrology department, Ambroise Paré hospital, APHP
last name: Eve Vilaine, MD
role: Study Director
affiliation: Nephrology department, Ambroise Paré hospital, APHP
last name: Paul GABARRE, MD
phone: +33 (0)1 49 09 56 45
email: paul.gabarre@aphp.fr
last name: Eve Vilaine, MD
phone: +33 (0)1 49 09 56 45
email: eve.vilaine@aphp.fr
facility: 
status: Recruiting
country: France
responsible party type: Sponsor
mesh term: Renal Insufficiency
mesh term: Acute Kidney Injury
mesh term: Acute Coronary Syndrome
mesh term: Syndrome
sharing ipd: No