<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/NCT02210897</url>
  </required_header>
  <id_info>
    <org_study_id>METC 14-2-016</org_study_id>
    <nct_id>NCT02210897</nct_id>
  </id_info>
  <brief_title>Influence of Renal Function on the Circadian Variation of Cardiac Troponin</brief_title>
  <official_title>Influence of Renal Function on the Circadian Variation of Cardiac Troponin</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Maastricht University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Maastricht University Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Cardiac troponin is the preferred biomarker for the diagnosis of acute myocardial infarction.&#xD;
      Whereas the diagnosis is based on an increase and/or decrease in the concentrations of&#xD;
      cardiac troponins with at least one value above the 99th percentile value of the reference&#xD;
      population together with the evidence of ischemia, serial sampling is needed. Knowledge of&#xD;
      the variation in cardiac troponin levels over time in individuals in a normal rest state (not&#xD;
      during an acute myocardial infarction), also called the biological variation, is important&#xD;
      regarding the interpretation of the serial cardiac troponin levels. A recent study by our&#xD;
      group showed a circadian rhythm in cardiac troponin levels. This circadian rhythm is&#xD;
      important regarding the interpretation of the serial cardiac troponin levels.&#xD;
&#xD;
      Increased cTnI and cTnT concentrations are common in subjects with renal impairment. The&#xD;
      mechanism of the elevated concentration of cTn in these subjects is still unclear. It is&#xD;
      hypothesized that impaired renal clearance contributes to elevated levels of cTn. However, it&#xD;
      is not clear whether renal function affects the biological variation and circadian rhythm of&#xD;
      cTn. The monitoring of the biological variation and circadian rhythm of cTn in subjects with&#xD;
      impaired renal function creates the opportunity to assess the effect of renal clearance on&#xD;
      the circadian rhythm of cardiac troponins.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">February 2016</completion_date>
  <primary_completion_date type="Actual">January 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <primary_outcome>
    <measure>Cardiac Troponins (cardiac troponin I (cTnI) and cardiac troponin T (cTnT))</measure>
    <time_frame>up to three months</time_frame>
  </primary_outcome>
  <other_outcome>
    <measure>24-hour automatic blood pressure measurements (diastolic and systolic blood pressure)</measure>
    <time_frame>total time 25 hours (first testday)</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Urine concentrations of creatinine, electrolytes and cardiac markers</measure>
    <time_frame>every 4 hours, total time 25 hours (first testday)</time_frame>
  </other_outcome>
  <enrollment type="Actual">20</enrollment>
  <condition>Chronic Kidney Diseases</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Individuals with chronic kidney disease (CKD) stage 3 and 4&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  CKD stage 3 or 4&#xD;
&#xD;
          -  No dialysis&#xD;
&#xD;
          -  No evidence of active, acute cardiovascular disease&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of acute myocardial infarction in the last year&#xD;
&#xD;
          -  History of pulmonary embolism in the last six months&#xD;
&#xD;
          -  Anemia (Hb &lt; 6.5 mmol/L)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Steven JR Meex, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Maastricht University Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Maastricht University Medical Center</name>
      <address>
        <city>Maastricht</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <reference>
    <citation>Klinkenberg LJ, van Dijk JW, Tan FE, van Loon LJ, van Dieijen-Visser MP, Meex SJ. Circulating cardiac troponin T exhibits a diurnal rhythm. J Am Coll Cardiol. 2014 May 6;63(17):1788-95. doi: 10.1016/j.jacc.2014.01.040. Epub 2014 Feb 26.</citation>
    <PMID>24583293</PMID>
  </reference>
  <verification_date>April 2015</verification_date>
  <study_first_submitted>August 5, 2014</study_first_submitted>
  <study_first_submitted_qc>August 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 7, 2014</study_first_posted>
  <last_update_submitted>February 17, 2016</last_update_submitted>
  <last_update_submitted_qc>February 17, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 18, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Renal Insufficiency, Chronic</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/NCT02210897
org study id: METC 14-2-016
nct id: NCT02210897
lead sponsor: 
has dmc: Yes
Cardiac troponin is the preferred biomarker for the diagnosis of acute myocardial infarction.
      Whereas the diagnosis is based on an increase and/or decrease in the concentrations of
      cardiac troponins with at least one value above the 99th percentile value of the reference
      population together with the evidence of ischemia, serial sampling is needed. Knowledge of
      the variation in cardiac troponin levels over time in individuals in a normal rest state (not
      during an acute myocardial infarction), also called the biological variation, is important
      regarding the interpretation of the serial cardiac troponin levels. A recent study by our
      group showed a circadian rhythm in cardiac troponin levels. This circadian rhythm is
      important regarding the interpretation of the serial cardiac troponin levels.

      Increased cTnI and cTnT concentrations are common in subjects with renal impairment. The
      mechanism of the elevated concentration of cTn in these subjects is still unclear. It is
      hypothesized that impaired renal clearance contributes to elevated levels of cTn. However, it
      is not clear whether renal function affects the biological variation and circadian rhythm of
      cTn. The monitoring of the biological variation and circadian rhythm of cTn in subjects with
      impaired renal function creates the opportunity to assess the effect of renal clearance on
      the circadian rhythm of cardiac troponins.
measure: Cardiac Troponins (cardiac troponin I (cTnI) and cardiac troponin T (cTnT))
time frame: up to three months
measure: 24-hour automatic blood pressure measurements (diastolic and systolic blood pressure)
time frame: total time 25 hours (first testday)
measure: Urine concentrations of creatinine, electrolytes and cardiac markers
time frame: every 4 hours, total time 25 hours (first testday)
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Steven JR Meex, PhD
role: Principal Investigator
affiliation: Maastricht University Medical Center
facility: 
country: Netherlands
citation: Klinkenberg LJ, van Dijk JW, Tan FE, van Loon LJ, van Dieijen-Visser MP, Meex SJ. Circulating cardiac troponin T exhibits a diurnal rhythm. J Am Coll Cardiol. 2014 May 6;63(17):1788-95. doi: 10.1016/j.jacc.2014.01.040. Epub 2014 Feb 26.
PMID: 24583293
responsible party type: Sponsor
mesh term: Kidney Diseases
mesh term: Renal Insufficiency, Chronic