<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/NCT01735500</url>
  </required_header>
  <id_info>
    <org_study_id>hsTnT Elective CAG</org_study_id>
    <nct_id>NCT01735500</nct_id>
  </id_info>
  <brief_title>hsTnT After Elective Coronary Angiography</brief_title>
  <official_title>Rise of hscTnT After Elective Coronary Angiography Without Coronary Intervention</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital Heidelberg</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital Heidelberg</source>
  <brief_summary>
    <textblock>
      A prospective Study, aiming to understand and analyse the key role of the novel High&#xD;
      Sensitivity Troponin T (hsTnT) within a group of patients undergoing an uncomplicated&#xD;
      coronary angiography without receiving any additional intervention. The peri-procedural&#xD;
      elevation of the hsTnT indicates some other factors being responsible for the elevation of&#xD;
      the hsTnT in absence of an acute coronary syndrome, such as physiological components or&#xD;
      micro-injuries. A one year follow-up has been collected.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 2010</start_date>
  <primary_completion_date type="Actual">November 2011</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>Cardiovascular mortality</measure>
    <time_frame>Up to 12 months after procedure</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">545</enrollment>
  <condition>Coronary Artery Disease</condition>
  <arm_group>
    <arm_group_label>CAG without PCI</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>CAG with PCI</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Consecutive patients with stable or unknown CAD undergoing CAG with/or without PCI.&#xD;
        Patients receiving additional examination, such as biopsy, Ablation or any other procedure&#xD;
        that could lead to myocardial injury resulting in elevation of the cardiac Troponin are&#xD;
        being excluded, as well as Patients with acute coronary syndrome.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - Stable or unknown CAD&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - Acute Coronary Syndrome&#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>Evangelos Giannitsis, Prof. Dr. med.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Cardiology, University Hospital of Heidelberg</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Cardiology - University Hospital of Heidelberg</name>
      <address>
        <city>Heidelberg</city>
        <zip>69120</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>December 2014</verification_date>
  <study_first_submitted>November 24, 2012</study_first_submitted>
  <study_first_submitted_qc>November 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 28, 2012</study_first_posted>
  <last_update_submitted>December 6, 2014</last_update_submitted>
  <last_update_submitted_qc>December 6, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 9, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital Heidelberg</investigator_affiliation>
    <investigator_full_name>Haitham Abu Sharar</investigator_full_name>
    <investigator_title>Dr. med.</investigator_title>
  </responsible_party>
  <keyword>Prei-procedural</keyword>
  <keyword>Elevation</keyword>
  <keyword>cardia Troponin T</keyword>
  <keyword>in stable</keyword>
  <keyword>unknown</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery Disease</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/NCT01735500
org study id: hsTnT Elective CAG
nct id: NCT01735500
lead sponsor: 
A prospective Study, aiming to understand and analyse the key role of the novel High
      Sensitivity Troponin T (hsTnT) within a group of patients undergoing an uncomplicated
      coronary angiography without receiving any additional intervention. The peri-procedural
      elevation of the hsTnT indicates some other factors being responsible for the elevation of
      the hsTnT in absence of an acute coronary syndrome, such as physiological components or
      micro-injuries. A one year follow-up has been collected.
observational model: Cohort
time perspective: Prospective
measure: Cardiovascular mortality
time frame: Up to 12 months after procedure
arm group label: CAG without PCI
arm group label: CAG with PCI
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Evangelos Giannitsis, Prof. Dr. med.
role: Principal Investigator
affiliation: Department of Cardiology, University Hospital of Heidelberg
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: University Hospital Heidelberg
investigator full name: Haitham Abu Sharar
investigator title: Dr. med.
mesh term: Coronary Artery Disease