<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/NCT03806725</url>
  </required_header>
  <id_info>
    <org_study_id>IRB-45901</org_study_id>
    <nct_id>NCT03806725</nct_id>
  </id_info>
  <brief_title>Safety of Iodinated Contrast in Liver Transplant Candidates With Decreased Renal Function Undergoing Coronary CT Angiography</brief_title>
  <official_title>Diagnostic Performance and Iodinated Contrast Safety of Coronary Computed Tomography Angiography in Liver Transplant Candidates With Decreased Renal Function</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stanford University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Stanford University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</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>
      This study evaluates the safety of iodinated contrast medium administered to liver transplant&#xD;
      candidates with decreased renal function undergoing coronary CT angiography. Incidence of&#xD;
      post-contrast acute kidney injury in liver transplant candidates with decreased renal&#xD;
      function and normal renal function will be compared.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Low osmolar non-ionic contrast medium (LOCM) is routinely used for contrast-enhanced computed&#xD;
      tomography (CT) including coronary computed tomography angiography (CCTA).&#xD;
&#xD;
      This study evaluates the effect of LOCM on liver transplant candidates with normal and&#xD;
      decreased renal function undergoing CCTA. Incidence of post-contrast acute kidney injury&#xD;
      (PC-AKI) will be compared between the two groups before and after contrast medium exposure.&#xD;
&#xD;
      LOCM is a potential cause of PC-AKI, especially in vulnerable population with decreased renal&#xD;
      function. According to the American College of Radiology (ACR) manual on contrast media,&#xD;
      however, many published studies on PC-AKI in the past have been heavily contaminated by bias&#xD;
      and conflation. More recent studies do not confirm a high risk of contrast induced&#xD;
      nephropathy.&#xD;
&#xD;
      End stage liver disease patients with normal renal function do not seem to be at a higher&#xD;
      risk of developing PC-AKI. Only limited data reporting a low incidence of PC-AKI after&#xD;
      contrast-enhanced CT in patients with liver cirrhosis and concomitant decreased renal&#xD;
      function exists. Proof of low PC-AKI in this specific population would allow to redirect&#xD;
      patients from invasive catheterization to CCTA as their cardiac clearance before&#xD;
      transplantation. This study will prospectively investigate the incidence of PC-AKI in this&#xD;
      specific at-risk population.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Difficulty with recruitment in this patient population.&#xD;
  </why_stopped>
  <start_date type="Anticipated">June 1, 2020</start_date>
  <completion_date type="Anticipated">March 30, 2022</completion_date>
  <primary_completion_date type="Anticipated">November 22, 2021</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>Post-contrast acute kidney injury</measure>
    <time_frame>Within 5 days after contrast medium exposure.</time_frame>
    <description>Incidence of acute kidney injury after iodine contrast medium exposure.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Acute Kidney Injury</condition>
  <condition>Renal Insufficiency, Chronic</condition>
  <condition>Contrast-induced Nephropathy</condition>
  <condition>Liver Transplantation</condition>
  <condition>Contrast Media</condition>
  <arm_group>
    <arm_group_label>Liver transplant (LTx) candidates with eGFR&gt;=60</arm_group_label>
    <description>Liver transplant candidates with renal function defined by eGFR above or equal to 60 ml/min/1.73m2, eGFR is determined by Cystatin C measurement.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>LTx candidates with eGFR&lt;60</arm_group_label>
    <description>Liver transplant candidates with decreased renal function.&#xD;
Defined by eGFR less than 60 ml/min/1.73m2, eGFR is determined by Cystatin C measurement.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Intravenous administration of iodinated contrast medium for coronary CT angiography</intervention_name>
    <description>Administration of iodinated contrast medium for coronary CT angiography</description>
    <arm_group_label>LTx candidates with eGFR&lt;60</arm_group_label>
    <arm_group_label>Liver transplant (LTx) candidates with eGFR&gt;=60</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Liver transplant candidates in evaluation process undergoing cardiac clearance&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - Liver transplant candidate, age &gt; 21 referred for coronary CT angiography, medium-risk&#xD;
        patient for coronary artery disease&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Liver transplant candidates who are at low-risk for coronary artery disease and&#xD;
             therefore do not need coronary CT angiography or invasive catheterization&#xD;
&#xD;
          -  Liver transplant candidates who are at high-risk for coronary artery disease and are&#xD;
             referred directly to invasive catheterization&#xD;
&#xD;
          -  Candidates with chronic kidney disease stage 4, with eGFR &lt;30 ml/min/1.73m2&#xD;
&#xD;
          -  Known or suspected allergy to standard iodine contrast medium&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Stanfor University</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>January 14, 2019</study_first_submitted>
  <study_first_submitted_qc>January 14, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 16, 2019</study_first_posted>
  <last_update_submitted>December 13, 2021</last_update_submitted>
  <last_update_submitted_qc>December 13, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 4, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Stanford University</investigator_affiliation>
    <investigator_full_name>Dominik Fleischmann, MD</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>Contrast-induced Nephropathy</keyword>
  <keyword>Contrast-induced acute kidney injury</keyword>
  <keyword>Coronary computed tomography angiography</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acute Kidney Injury</mesh_term>
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Renal Insufficiency</mesh_term>
    <mesh_term>Renal Insufficiency, Chronic</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/NCT03806725
org study id: IRB-45901
nct id: NCT03806725
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
This study evaluates the safety of iodinated contrast medium administered to liver transplant
      candidates with decreased renal function undergoing coronary CT angiography. Incidence of
      post-contrast acute kidney injury in liver transplant candidates with decreased renal
      function and normal renal function will be compared.
Low osmolar non-ionic contrast medium (LOCM) is routinely used for contrast-enhanced computed
      tomography (CT) including coronary computed tomography angiography (CCTA).

      This study evaluates the effect of LOCM on liver transplant candidates with normal and
      decreased renal function undergoing CCTA. Incidence of post-contrast acute kidney injury
      (PC-AKI) will be compared between the two groups before and after contrast medium exposure.

      LOCM is a potential cause of PC-AKI, especially in vulnerable population with decreased renal
      function. According to the American College of Radiology (ACR) manual on contrast media,
      however, many published studies on PC-AKI in the past have been heavily contaminated by bias
      and conflation. More recent studies do not confirm a high risk of contrast induced
      nephropathy.

      End stage liver disease patients with normal renal function do not seem to be at a higher
      risk of developing PC-AKI. Only limited data reporting a low incidence of PC-AKI after
      contrast-enhanced CT in patients with liver cirrhosis and concomitant decreased renal
      function exists. Proof of low PC-AKI in this specific population would allow to redirect
      patients from invasive catheterization to CCTA as their cardiac clearance before
      transplantation. This study will prospectively investigate the incidence of PC-AKI in this
      specific at-risk population.
observational model: Cohort
time perspective: Prospective
measure: Post-contrast acute kidney injury
time frame: Within 5 days after contrast medium exposure.
description: Incidence of acute kidney injury after iodine contrast medium exposure.
arm group label: Liver transplant (LTx) candidates with eGFR>=60
description: Liver transplant candidates with renal function defined by eGFR above or equal to 60 ml/min/1.73m2, eGFR is determined by Cystatin C measurement.
arm group label: LTx candidates with eGFR<60
description: Liver transplant candidates with decreased renal function.
Defined by eGFR less than 60 ml/min/1.73m2, eGFR is determined by Cystatin C measurement.
intervention type: Diagnostic Test
intervention name: Intravenous administration of iodinated contrast medium for coronary CT angiography
description: Administration of iodinated contrast medium for coronary CT angiography
arm group label: LTx candidates with eGFR<60
arm group label: Liver transplant (LTx) candidates with eGFR>=60
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 21 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Stanford University
investigator full name: Dominik Fleischmann, MD
investigator title: MD
mesh term: Acute Kidney Injury
mesh term: Kidney Diseases
mesh term: Renal Insufficiency
mesh term: Renal Insufficiency, Chronic
sharing ipd: No