<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/NCT02192528</url>
  </required_header>
  <id_info>
    <org_study_id>008</org_study_id>
    <nct_id>NCT02192528</nct_id>
  </id_info>
  <brief_title>Vitamin D and Outcome in Cardiac Surgery</brief_title>
  <acronym>Calcitop</acronym>
  <official_title>25-Hydroxyvitamin D, 1,25-Dihydroxyvitamin D and Postoperative Outcome in Cardiac Surgical Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Heart and Diabetes Center North-Rhine Westfalia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Heart and Diabetes Center North-Rhine Westfalia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      We will use a retrospective data analysis to evaluate the association of the two vitamin D&#xD;
      metabolites 25-hydroxyvitamin D and 1,25-dihydroxyvitamin D with clinical outcome in cardiac&#xD;
      surgical patients. The occurrence of several postoperative adverse events such as myocardial&#xD;
      infarction, low cardiac output syndrome, stroke and in-hospital death will be assessed from&#xD;
      cardiac surgery to discharge. In addition, we will assess the association of the two vitamin&#xD;
      D metaboolites with the duration of mechanical ventilatory support and intensive care unit&#xD;
      stay from cardiac surgery to discharge. Moreover, in-hospital stay will be assessed according&#xD;
      to vitamin D metabolite levels.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In a retrospective data analysis, we will evaluate the association of vitamin D metabolites&#xD;
      (circulating 25-hydroxyvitamin D and 1,25-dihydroxyvitamin D) with MACCE (major cardiac or&#xD;
      cerebrovascular event) in cardiac surgical patients. The occurrence of several postoperative&#xD;
      adverse events such as myocardial infarction, low cardiac output syndrome, stroke and&#xD;
      in-hospital death will be assessed from cardiac surgery to discharge. Approximately 4,000&#xD;
      data sets from mid of 2012 until the end of 2013 will be analyzed. In all patients, we will&#xD;
      also assess the association of vitamin D metabolite levels with the duration of mechanical&#xD;
      ventilatory support and intensive care unit stay from cardiac surgery to discharge. Moreover,&#xD;
      in-hospital stay will be assessed according to vitamin D status&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2012</start_date>
  <completion_date type="Actual">July 2014</completion_date>
  <primary_completion_date type="Actual">November 2013</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>major cardiac or cerebrovascular event (MACCE)</measure>
    <time_frame>Patients will be followed for an average time of 14 days from cardiac surgery to discharge</time_frame>
    <description>MACCE is defined as in-hospital death, myocardial infarction, low cardiac output syndrome or stroke.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>duration of ventilatory support</measure>
    <time_frame>Patients will be followed for an average time of 14 days from cardiac surgery to discharge</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>intensive care unit stay</measure>
    <time_frame>Patients will be followed for an average time of 14 days from cardiac surgery to discharge</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>in-hospital stay</measure>
    <time_frame>Patients will be followed for an average time of 14 days from cardiac surgery to discharge</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>infection</measure>
    <time_frame>Patients will be followed for an average time of 14 days from cardiac surgery to discharge</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">3852</enrollment>
  <condition>Cardiovascular Disease</condition>
  <arm_group>
    <arm_group_label>cardiac surgical patients</arm_group_label>
    <description>patients undergoing a cardiac surgical procedure</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        cardiac surgical patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  cardiac surgical patients aged 18 years and older&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  age &lt; 18 years&#xD;
&#xD;
          -  heart transplant recipients&#xD;
&#xD;
          -  pacemaker or defibrillator implantation&#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>Armin Zittermann, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Heart &amp; Diabetes Center North-Rhine Westfalia, Germany</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Heart &amp; Diabetes Center North-Rhine Westphalia</name>
      <address>
        <city>Bad Oeynhausen</city>
        <state>NRW</state>
        <zip>32545</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <reference>
    <citation>Zittermann A, Kuhn J, Dreier J, Knabbe C, Gummert JF, Borgermann J. Vitamin D status and the risk of major adverse cardiac and cerebrovascular events in cardiac surgery. Eur Heart J. 2013 May;34(18):1358-64. doi: 10.1093/eurheartj/ehs468. Epub 2013 Jan 12.</citation>
    <PMID>23315905</PMID>
  </reference>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 15, 2014</study_first_submitted>
  <study_first_submitted_qc>July 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 16, 2014</study_first_posted>
  <last_update_submitted>August 10, 2016</last_update_submitted>
  <last_update_submitted_qc>August 10, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 11, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>vitamin D</keyword>
  <keyword>25-hydroxyvitamin D</keyword>
  <keyword>1,25-dihydroxyvitamin D</keyword>
  <keyword>MACCE</keyword>
  <keyword>mortality</keyword>
  <keyword>cardiac</keyword>
  <keyword>cerebrovascular</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiovascular Diseases</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/NCT02192528
org study id: 008
nct id: NCT02192528
lead sponsor: 
has dmc: No
We will use a retrospective data analysis to evaluate the association of the two vitamin D
      metabolites 25-hydroxyvitamin D and 1,25-dihydroxyvitamin D with clinical outcome in cardiac
      surgical patients. The occurrence of several postoperative adverse events such as myocardial
      infarction, low cardiac output syndrome, stroke and in-hospital death will be assessed from
      cardiac surgery to discharge. In addition, we will assess the association of the two vitamin
      D metaboolites with the duration of mechanical ventilatory support and intensive care unit
      stay from cardiac surgery to discharge. Moreover, in-hospital stay will be assessed according
      to vitamin D metabolite levels.
In a retrospective data analysis, we will evaluate the association of vitamin D metabolites
      (circulating 25-hydroxyvitamin D and 1,25-dihydroxyvitamin D) with MACCE (major cardiac or
      cerebrovascular event) in cardiac surgical patients. The occurrence of several postoperative
      adverse events such as myocardial infarction, low cardiac output syndrome, stroke and
      in-hospital death will be assessed from cardiac surgery to discharge. Approximately 4,000
      data sets from mid of 2012 until the end of 2013 will be analyzed. In all patients, we will
      also assess the association of vitamin D metabolite levels with the duration of mechanical
      ventilatory support and intensive care unit stay from cardiac surgery to discharge. Moreover,
      in-hospital stay will be assessed according to vitamin D status
observational model: Cohort
time perspective: Prospective
measure: major cardiac or cerebrovascular event (MACCE)
time frame: Patients will be followed for an average time of 14 days from cardiac surgery to discharge
description: MACCE is defined as in-hospital death, myocardial infarction, low cardiac output syndrome or stroke.
measure: duration of ventilatory support
time frame: Patients will be followed for an average time of 14 days from cardiac surgery to discharge
measure: intensive care unit stay
time frame: Patients will be followed for an average time of 14 days from cardiac surgery to discharge
measure: in-hospital stay
time frame: Patients will be followed for an average time of 14 days from cardiac surgery to discharge
measure: infection
time frame: Patients will be followed for an average time of 14 days from cardiac surgery to discharge
arm group label: cardiac surgical patients
description: patients undergoing a cardiac surgical procedure
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Armin Zittermann, PhD
role: Principal Investigator
affiliation: Heart & Diabetes Center North-Rhine Westfalia, Germany
facility: 
country: Germany
citation: Zittermann A, Kuhn J, Dreier J, Knabbe C, Gummert JF, Borgermann J. Vitamin D status and the risk of major adverse cardiac and cerebrovascular events in cardiac surgery. Eur Heart J. 2013 May;34(18):1358-64. doi: 10.1093/eurheartj/ehs468. Epub 2013 Jan 12.
PMID: 23315905
responsible party type: Sponsor
mesh term: Cardiovascular Diseases
sharing ipd: No