<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/NCT02195726</url>
  </required_header>
  <id_info>
    <org_study_id>201301</org_study_id>
    <nct_id>NCT02195726</nct_id>
  </id_info>
  <brief_title>Efficacy of RIPC to Reduce AKI for Patients Undergoing PCI</brief_title>
  <acronym>EUROCRIPS</acronym>
  <official_title>The EUROpean and Asian Cardiac and Renal Remote Ischemic Pre-conditioning Study : A Prospective, Randomized Control Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Azienda Ospedaliera Città della Salute e della Scienza di Torino</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Azienda Ospedaliera Città della Salute e della Scienza di Torino</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the present study is to determine if remote ischemic preconditioning reduces&#xD;
      incidence of acute kidney injury in patients with reduced kidney function undergoing&#xD;
      Percutaneous Coronary Intervention.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Acute kidney injury negatively impacts on prognosis after PCI, and only hydratation have&#xD;
      shown to reduce this complication.&#xD;
&#xD;
      Remote ischemic preconditioning has been demonstrated to reduce periprocedural MI, while&#xD;
      impact on aki remains to be assessed&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">July 2014</completion_date>
  <primary_completion_date type="Actual">July 2014</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of acute kidney injury</measure>
    <time_frame>24 and 48 hours after PCI</time_frame>
    <description>Acute Kidney Injury defined as Acute kidney injury is defined as an increase serum creatinine greater than 0.5 mg/dL, or by a relative increase of at least 25% over the baseline value within a period of 48-hours after contrast medium administration</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of periprocedural myocardial infarction</measure>
    <time_frame>24 and 48 hours after PCI</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1110</enrollment>
  <condition>Acute Kidney Injury</condition>
  <arm_group>
    <arm_group_label>Sham remote ischemic preconditioning'</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>In the control group Sham remote ischemic preconditioning will be performed with inflation of 10 mmHg more than baseline</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Remote ischemic preconditioning</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In the experimental group, patients will receive for four times 5-minute inflations of a blood pressure cuff to 200 mmHg around the upper non dominant arm (or if systolic pressure is more than 150 mmHg, inflation will reach 50 mmHg upper than baseline), followed by 5-minute intervals of reperfusion.&#xD;
In subjects presenting with BMI &gt; 30 a dedicated blood pressure cuff for obese patients will be used. Coronary angiography will be performed in 45 minutes from last inflation</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Remote ischemic preconditioning</intervention_name>
    <description>four times 5-minute inflations of a blood pressure cuff to 200 mmHg around the upper non dominant arm (or if systolic pressure is more than 150 mmHg, inflation will reach 50 mmHg up per than baseline), followed by 5-minute intervals of reperfusion.</description>
    <arm_group_label>Remote ischemic preconditioning</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Sham remote ischemic preconditioning</intervention_name>
    <description>In the control group sham preconditioning will be performed with inflation of 10 mmHg more than baseline.</description>
    <arm_group_label>Sham remote ischemic preconditioning'</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  undergoing PCI with stenting for all clinical indications&#xD;
&#xD;
          -  carrying (with) a renal clearance less than 60 mL/min/1.73 m2 and more than 30&#xD;
             mL/min/1.73 m2 (evaluated through MDRD); ù&#xD;
&#xD;
          -  younger than 85 years old.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  ST Segment Elevation Myocardial Infarction (STEMI), unstable hemodynamic presentations&#xD;
             (cardiogenic shock) or ongoing severe arrhythmias;&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Institut Cardiovasculaire Paris Sud Hôpital Jacques Cartier</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Unità Operativa di Cardiologia Presidio Ospedaliero Misericordia Via Senese 161 58100 Grosseto</name>
      <address>
        <city>Grosseto</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliere Senese Siena</name>
      <address>
        <city>Siena</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Maria Vittoria</name>
      <address>
        <city>Turin</city>
        <zip>10016</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>San Luigi</name>
      <address>
        <city>Turin</city>
        <zip>10016</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Città Della Salute e Della Scienza</name>
      <address>
        <city>Turin</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clínico San Carlos</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
    <country>Italy</country>
    <country>Spain</country>
  </location_countries>
  <link>
    <url>http://www.cardiogroup.org/index.php?cat=home</url>
    <description>our research website group</description>
  </link>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>January 14, 2013</study_first_submitted>
  <study_first_submitted_qc>July 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 21, 2014</study_first_posted>
  <last_update_submitted>July 18, 2014</last_update_submitted>
  <last_update_submitted_qc>July 18, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 21, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Azienda Ospedaliera Città della Salute e della Scienza di Torino</investigator_affiliation>
    <investigator_full_name>Claudio Moretti</investigator_full_name>
    <investigator_title>Dottor, Head of the Catch Lab</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acute Kidney Injury</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/NCT02195726
org study id: 201301
nct id: NCT02195726
lead sponsor: 
has dmc: No
The purpose of the present study is to determine if remote ischemic preconditioning reduces
      incidence of acute kidney injury in patients with reduced kidney function undergoing
      Percutaneous Coronary Intervention.
Acute kidney injury negatively impacts on prognosis after PCI, and only hydratation have
      shown to reduce this complication.

      Remote ischemic preconditioning has been demonstrated to reduce periprocedural MI, while
      impact on aki remains to be assessed
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Incidence of acute kidney injury
time frame: 24 and 48 hours after PCI
description: Acute Kidney Injury defined as Acute kidney injury is defined as an increase serum creatinine greater than 0.5 mg/dL, or by a relative increase of at least 25% over the baseline value within a period of 48-hours after contrast medium administration
measure: Incidence of periprocedural myocardial infarction
time frame: 24 and 48 hours after PCI
arm group label: Sham remote ischemic preconditioning'
arm group type: Sham Comparator
description: In the control group Sham remote ischemic preconditioning will be performed with inflation of 10 mmHg more than baseline
arm group label: Remote ischemic preconditioning
arm group type: Experimental
description: In the experimental group, patients will receive for four times 5-minute inflations of a blood pressure cuff to 200 mmHg around the upper non dominant arm (or if systolic pressure is more than 150 mmHg, inflation will reach 50 mmHg upper than baseline), followed by 5-minute intervals of reperfusion.
In subjects presenting with BMI > 30 a dedicated blood pressure cuff for obese patients will be used. Coronary angiography will be performed in 45 minutes from last inflation
intervention type: Procedure
intervention name: Remote ischemic preconditioning
description: four times 5-minute inflations of a blood pressure cuff to 200 mmHg around the upper non dominant arm (or if systolic pressure is more than 150 mmHg, inflation will reach 50 mmHg up per than baseline), followed by 5-minute intervals of reperfusion.
arm group label: Remote ischemic preconditioning
intervention type: Procedure
intervention name: Sham remote ischemic preconditioning
description: In the control group sham preconditioning will be performed with inflation of 10 mmHg more than baseline.
arm group label: Sham remote ischemic preconditioning'
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: France
country: Italy
country: Spain
url: http://www.cardiogroup.org/index.php?cat=home
description: our research website group
responsible party type: Principal Investigator
investigator affiliation: Azienda Ospedaliera Città della Salute e della Scienza di Torino
investigator full name: Claudio Moretti
investigator title: Dottor, Head of the Catch Lab
mesh term: Acute Kidney Injury