<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/NCT03305874</url>
  </required_header>
  <id_info>
    <org_study_id>IRB17-1005</org_study_id>
    <nct_id>NCT03305874</nct_id>
  </id_info>
  <brief_title>Automated Prediction and Prevention of Contrast Induced Nephropathy After Cardiac Catheterization</brief_title>
  <official_title>Automated Prediction and Prevention of Contrast Induced Nephropathy After Cardiac Catheterization</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Chicago</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Philips Healthcare</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Chicago</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Contrast agent is typically used during routine cardiac intervention in order to enhance the&#xD;
      imaging necessary to perform the procedure. Using this contrast agent could lead to kidney&#xD;
      injury, called contrast induced nephropathy (CIN). Currently, the methods used to reduce the&#xD;
      risk of CIN include reducing the amount of contrast agent used and using a hydration strategy&#xD;
      during procedure. A computer-based risk tool has been developed which reports a risk score&#xD;
      for the likelihood a person undergoing cardiac intervention gets CIN and a proposed&#xD;
      corresponding hydration strategy to reduce the risk of CIN. The purpose of this study is to&#xD;
      determine whether the rate of CIN decreases when the treating physician has access to this&#xD;
      risk tool during the procedure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a case-control series comparing a strategy using a computer-based contrast induced&#xD;
      nephropathy (CBCIN) risk tool in patients undergoing PCI versus usual care. Only inpatients&#xD;
      will be included in this study. These inpatients will be compared to historical controls&#xD;
      obtained using the medical record of age- and gender-matched inpatients who underwent cardiac&#xD;
      catheterization with at least two consecutive daily post-procedure creatinine values. The&#xD;
      percentage PCI will be matched in the retrospective series.&#xD;
&#xD;
      In the prospective group, the operator will be exposed to the CBCIN risk tool before and&#xD;
      during care delivery with estimated CIN risk. The CBCIN risk tool estimates CIN risk based on&#xD;
      the status of known risk factors (and suggests an associated standard hydration strategy&#xD;
      based on left-ventricular end-diastolic pressure), which are automatically prepared from the&#xD;
      patient's Electronic Medical Record and presented to the operator for review. This&#xD;
      functionality has been evaluated in previous research and was found to be stable and&#xD;
      reliable. Based on the data presented by and reviewed in the CBCIN risk tool, the operator&#xD;
      may use the information and adjust therapy as clinically indicated (i.e. the risk tool is not&#xD;
      the basis for clinical decisions). Following the PCI, serum creatinine will be measured as&#xD;
      per treating physician, but those who undergo at least two consecutive daily serum creatinine&#xD;
      measurements starting the day after the procedure will be included in the study. These&#xD;
      patients will be called 6 months and 12 months post-procedure to determine mortality and&#xD;
      re-hospitalization status.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 7, 2018</start_date>
  <completion_date type="Actual">July 17, 2023</completion_date>
  <primary_completion_date type="Actual">July 17, 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Development of CIN</measure>
    <time_frame>up to 4 days</time_frame>
    <description>increase in serum creatinine of ≥0.3 mg/dL or ≥50% from the value before the procedure to the highest post-procedure value on days 1-4</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">5</enrollment>
  <condition>Contrast-induced Nephropathy</condition>
  <arm_group>
    <arm_group_label>Study Group</arm_group_label>
    <description>Prospectively, inpatients undergoing percutaneous coronary intervention (PCI) will be consented, and the computer-based contrast induced nephropathy (CBCIN) risk score will be calculated and displayed to the operator, along with suggested standard CIN-avoidance strategies during the PCI. Following the PCI, serum creatinine will be measured as per treating physician, but those who undergo at least two consecutive daily serum creatinine measurements starting the day after the procedure will be included in the study. These patients will be called 6 months and 12 months post-procedure to determine mortality and re-hospitalization status.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Comparator Group</arm_group_label>
    <description>Retrospectively, inpatients who underwent PCI and had at least two consecutive daily serum creatinine measurements will be selected. These patients will then be matched to the prospective patients, and matched by age and gender. Baseline CBCIN score will be calculated and other demographic and outcomes information will be obtained from medical records review.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Exposure to CBCIN risk score</intervention_name>
    <description>The computer-based contrast induced nephropathy (CBCIN) risk score and associated standard hydration strategy will be displayed on a monitor in front of the treating interventional cardiologist during the entirety of the PCI case. Since this scoring system and hydration strategy are both available in the peer-reviewed literature, clinical use of these data and implementation of a CIN-avoidance strategy is not experimental; however, the display of these data to interventional cardiologists is experimental. Based on exposure to these data, the treating interventional cardiologist may use the information as clinically appropriate (i.e. it is not the basis for clinical decisions).</description>
    <arm_group_label>Study Group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        A prospective patient may be considered for the study if they are referred to the&#xD;
        University of Chicago Cardiac Catheterization Laboratory as an inpatient for either a&#xD;
        planned PCI or a diagnostic angiogram with high likelihood for PCI. For the retrospective&#xD;
        control series, subjects will be selected from the electronic medical record starting from&#xD;
        the date of the study protocol submission backwards until January 1, 2010 if they meet&#xD;
        inclusion and exclusion criteria.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Inpatients age ≥ 21 years seen at the University of Chicago Medical Center with a clinical&#xD;
        indication for cardiac catheterization with high likelihood of PCI, or those undergoing&#xD;
        planned PCI will be screened for enrollment into our study. Following PCI, these patients&#xD;
        must have at least two consecutive daily creatinine measurements starting the day after the&#xD;
        PCI, but clinically-indicated according to the inpatient treating physician.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients being discharged the day after the PCI.&#xD;
&#xD;
          -  Patients who are screened but do not receive PCI.&#xD;
&#xD;
          -  Patients who do not have at least two consecutive daily creatinine measurements&#xD;
             starting the day after the PCI.&#xD;
&#xD;
          -  Patients undergoing emergency primary percutaneous coronary intervention for&#xD;
             ST-segment elevation myocardial infarction.&#xD;
&#xD;
          -  Patients in cardiogenic shock.&#xD;
&#xD;
          -  Patients with end-stage renal disease or who are on renal replacement therapy.&#xD;
&#xD;
          -  Patients requiring planned mechanical circulatory support for the PCI.&#xD;
&#xD;
          -  Pregnant women (standard PCI screening)&#xD;
&#xD;
          -  Vulnerable populations such as children, college students, prisoners, non-English&#xD;
             speakers, and those with diminished decision-making capacity&#xD;
&#xD;
          -  Inability or refusal to consent for the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>John E. A. Blair, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Chicago</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The University of Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>October 4, 2017</study_first_submitted>
  <study_first_submitted_qc>October 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 10, 2017</study_first_posted>
  <last_update_submitted>August 23, 2023</last_update_submitted>
  <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 24, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>contrast-induced nephropathy (CIN)</keyword>
  <keyword>percutaneous coronary intervention (PCI)</keyword>
  <keyword>computer-based risk tool</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Diseases</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/NCT03305874
org study id: IRB17-1005
nct id: NCT03305874
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Contrast agent is typically used during routine cardiac intervention in order to enhance the
      imaging necessary to perform the procedure. Using this contrast agent could lead to kidney
      injury, called contrast induced nephropathy (CIN). Currently, the methods used to reduce the
      risk of CIN include reducing the amount of contrast agent used and using a hydration strategy
      during procedure. A computer-based risk tool has been developed which reports a risk score
      for the likelihood a person undergoing cardiac intervention gets CIN and a proposed
      corresponding hydration strategy to reduce the risk of CIN. The purpose of this study is to
      determine whether the rate of CIN decreases when the treating physician has access to this
      risk tool during the procedure.
This is a case-control series comparing a strategy using a computer-based contrast induced
      nephropathy (CBCIN) risk tool in patients undergoing PCI versus usual care. Only inpatients
      will be included in this study. These inpatients will be compared to historical controls
      obtained using the medical record of age- and gender-matched inpatients who underwent cardiac
      catheterization with at least two consecutive daily post-procedure creatinine values. The
      percentage PCI will be matched in the retrospective series.

      In the prospective group, the operator will be exposed to the CBCIN risk tool before and
      during care delivery with estimated CIN risk. The CBCIN risk tool estimates CIN risk based on
      the status of known risk factors (and suggests an associated standard hydration strategy
      based on left-ventricular end-diastolic pressure), which are automatically prepared from the
      patient's Electronic Medical Record and presented to the operator for review. This
      functionality has been evaluated in previous research and was found to be stable and
      reliable. Based on the data presented by and reviewed in the CBCIN risk tool, the operator
      may use the information and adjust therapy as clinically indicated (i.e. the risk tool is not
      the basis for clinical decisions). Following the PCI, serum creatinine will be measured as
      per treating physician, but those who undergo at least two consecutive daily serum creatinine
      measurements starting the day after the procedure will be included in the study. These
      patients will be called 6 months and 12 months post-procedure to determine mortality and
      re-hospitalization status.
observational model: Case-Control
time perspective: Other
measure: Development of CIN
time frame: up to 4 days
description: increase in serum creatinine of ≥0.3 mg/dL or ≥50% from the value before the procedure to the highest post-procedure value on days 1-4
arm group label: Study Group
description: Prospectively, inpatients undergoing percutaneous coronary intervention (PCI) will be consented, and the computer-based contrast induced nephropathy (CBCIN) risk score will be calculated and displayed to the operator, along with suggested standard CIN-avoidance strategies during the PCI. Following the PCI, serum creatinine will be measured as per treating physician, but those who undergo at least two consecutive daily serum creatinine measurements starting the day after the procedure will be included in the study. These patients will be called 6 months and 12 months post-procedure to determine mortality and re-hospitalization status.
arm group label: Comparator Group
description: Retrospectively, inpatients who underwent PCI and had at least two consecutive daily serum creatinine measurements will be selected. These patients will then be matched to the prospective patients, and matched by age and gender. Baseline CBCIN score will be calculated and other demographic and outcomes information will be obtained from medical records review.
intervention type: Other
intervention name: Exposure to CBCIN risk score
description: The computer-based contrast induced nephropathy (CBCIN) risk score and associated standard hydration strategy will be displayed on a monitor in front of the treating interventional cardiologist during the entirety of the PCI case. Since this scoring system and hydration strategy are both available in the peer-reviewed literature, clinical use of these data and implementation of a CIN-avoidance strategy is not experimental; however, the display of these data to interventional cardiologists is experimental. Based on exposure to these data, the treating interventional cardiologist may use the information as clinically appropriate (i.e. it is not the basis for clinical decisions).
arm group label: Study Group
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: John E. A. Blair, MD
role: Principal Investigator
affiliation: University of Chicago
facility: 
country: United States
responsible party type: Sponsor
mesh term: Kidney Diseases