<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/NCT02263820</url>
  </required_header>
  <id_info>
    <org_study_id>HSDX-1502</org_study_id>
    <nct_id>NCT02263820</nct_id>
  </id_info>
  <brief_title>Novel Biomarkers for Risk Prediction of Contrast-Induced Acute Kidney Injury Post Coronary Angiography</brief_title>
  <acronym>NORDICA</acronym>
  <official_title>Novel Biomarkers for Risk Prediction of Contrast-Induced Acute Kidney Injury Post Coronary Angiography (NORDICA Study)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sapere Bio</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of North Carolina, Chapel Hill</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Sapere Bio</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Contrast-induced acute kidney injury (CI-AKI) has been recognized as the third most common&#xD;
      cause of hospital acquired AKI, after hypotension-associated hypo-perfusion and&#xD;
      post-operative AKI. The development of CI-AKI after cardiac catheterization is associated&#xD;
      with a significant increase in both short-term and long-term mortality and morbidities, as&#xD;
      well as an increase in length of stay and cost.&#xD;
&#xD;
      The only marker of renal function that has predictive ability is creatinine and it has&#xD;
      significant limitations in identifying patients who will develop AKI. Therefore, a diagnostic&#xD;
      test for predicting CI-AKI risk would have widespread clinical utility.&#xD;
&#xD;
      The primary purpose of this study is to measure the association between baseline expression&#xD;
      of senescence markers in blood using SenesceTest and the occurrence of CI-AKI post cardiac&#xD;
      catheterization.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2015</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">July 2016</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>Changes in serum creatinine levels (absolute and percentage)</measure>
    <time_frame>Measured 48-72h after catheterization</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Major Adverse Clinical Events (MACE, a composite of all-cause mortality, myocardial infarction or renal replacement therapy)</measure>
    <time_frame>Within 90 days after catheterization</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Admission to the ICU</measure>
    <time_frame>Within 90 days after catheterization</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">185</enrollment>
  <condition>Acute Kidney Injury</condition>
  <condition>Renal Insufficiency</condition>
  <condition>Kidney Diseases</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Urine, plasma, buffy coat&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Adults undergoing cardiac catheterization with or without percutaneous coronary&#xD;
        intervention (PCI)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients (&gt;18 yo) undergoing invasive coronary angiography with or without&#xD;
             percutaneous coronary intervention (PCI), that are predicted to have ≥14% risk of&#xD;
             developing AKI as defined by Mehran et al.&#xD;
&#xD;
          -  Medically compliant and able to consent and follow detailed directions&#xD;
&#xD;
          -  Agree to additional collection of blood sample 48-72h post cardiac catheterization&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of acute, active infection (e.g. HIV, pneumonia, septic shock).&#xD;
&#xD;
          -  Contrast media exposure within last 48h&#xD;
&#xD;
          -  Presenting with systolic time-segment elevation myocardial infarction.&#xD;
&#xD;
          -  Presence of cardiogenic shock&#xD;
&#xD;
          -  Presence of hemodynamic instability or requiring pressors or intra-aortic balloon pump&#xD;
&#xD;
          -  Severe kidney disease with estimated glomerular filtration rate &lt;30 mL/min/1.73m2 or&#xD;
             receiving dialysis for end stage renal disease&#xD;
&#xD;
          -  Kidney transplant and liver transplant patients and all patients currently on&#xD;
             immunosuppressants&#xD;
&#xD;
          -  Severe heart failure with known ejection fraction &lt;25%&#xD;
&#xD;
          -  Prior heart transplant&#xD;
&#xD;
          -  Chronic liver disease /cirrhosis&#xD;
&#xD;
          -  Patients actively undergoing chemotherapy or radiation treatment for any indication.&#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>George A Stouffer, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of North Carolina</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UNC Center for Heart &amp; Vascular Care</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>October 8, 2014</study_first_submitted>
  <study_first_submitted_qc>October 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 13, 2014</study_first_posted>
  <last_update_submitted>August 15, 2018</last_update_submitted>
  <last_update_submitted_qc>August 15, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 17, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Acute Kidney Injury</keyword>
  <keyword>Acute Renal Failure</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Acute Kidney Injury</mesh_term>
    <mesh_term>Renal Insufficiency</mesh_term>
    <mesh_term>Wounds and Injuries</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/NCT02263820
org study id: HSDX-1502
nct id: NCT02263820
lead sponsor: 
collaborator: 
has dmc: No
Contrast-induced acute kidney injury (CI-AKI) has been recognized as the third most common
      cause of hospital acquired AKI, after hypotension-associated hypo-perfusion and
      post-operative AKI. The development of CI-AKI after cardiac catheterization is associated
      with a significant increase in both short-term and long-term mortality and morbidities, as
      well as an increase in length of stay and cost.

      The only marker of renal function that has predictive ability is creatinine and it has
      significant limitations in identifying patients who will develop AKI. Therefore, a diagnostic
      test for predicting CI-AKI risk would have widespread clinical utility.

      The primary purpose of this study is to measure the association between baseline expression
      of senescence markers in blood using SenesceTest and the occurrence of CI-AKI post cardiac
      catheterization.
observational model: Cohort
time perspective: Prospective
measure: Changes in serum creatinine levels (absolute and percentage)
time frame: Measured 48-72h after catheterization
measure: Major Adverse Clinical Events (MACE, a composite of all-cause mortality, myocardial infarction or renal replacement therapy)
time frame: Within 90 days after catheterization
measure: Admission to the ICU
time frame: Within 90 days after catheterization
Urine, plasma, buffy coat
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: George A Stouffer, MD
role: Principal Investigator
affiliation: University of North Carolina
facility: 
country: United States
responsible party type: Sponsor
mesh term: Kidney Diseases
mesh term: Acute Kidney Injury
mesh term: Renal Insufficiency
mesh term: Wounds and Injuries