<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/NCT03815123</url>
  </required_header>
  <id_info>
    <org_study_id>S-758/2018</org_study_id>
    <nct_id>NCT03815123</nct_id>
  </id_info>
  <brief_title>Register Kardialer Computertomographie</brief_title>
  <official_title>Register Kardialer Computertomographie</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Das Radiologische Zentrum</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Heidelberg University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Das Radiologische Zentrum</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this Heidelberg Cardiac CT Registry (Register kardiale Computertomographie) is to&#xD;
      assess the diagnostic and prognostic perfomance of cardiac CT exminations in a real-world&#xD;
      patient population.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Anthropometric data, medical history and results of the CT examinations are collected in a&#xD;
      database in order to adressing various scientific questions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 6, 2018</start_date>
  <completion_date type="Anticipated">December 2029</completion_date>
  <primary_completion_date type="Anticipated">December 2028</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>10 Years</target_duration>
  <primary_outcome>
    <measure>coronary CT angiography</measure>
    <time_frame>10 years</time_frame>
    <description>Evaluation of degree of coronary artery stenosis</description>
  </primary_outcome>
  <primary_outcome>
    <measure>coronary CT angiography</measure>
    <time_frame>10 years</time_frame>
    <description>Assessment of coronary plaque composition</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Agreement with other imaging modalities</measure>
    <time_frame>10 years</time_frame>
    <description>Agreement with other imaging modalities</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Occurence of MACE</measure>
    <time_frame>10 years</time_frame>
    <description>Occurence of major adverse events</description>
  </primary_outcome>
  <enrollment type="Anticipated">10000</enrollment>
  <condition>Evaluation of CT in Coronary Artery Stenosis</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>cardiac CT</intervention_name>
    <description>The cardiac CT examinations are indicated by the referring physician. The participation in this study has no influence on the further diagnostic and therapeutic regimen.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects referred for cardiac CT examination by their physician&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        • Subjects referred for cardiac CT examination by their physician&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        • none&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Johannes Goerich, Prof.</last_name>
    <phone>+491703042496</phone>
    <email>jgoerich@t-online.de</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Sebastian J Buss, Prof.</last_name>
    <phone>+49 6221 316930</phone>
    <email>prof.buss@das-radiologische-zentrum.de</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Radiologische Praxis Heidelberg</name>
      <address>
        <city>Heidelberg</city>
        <state>Baden-Württemberg</state>
        <zip>69126</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Johannes Goerich, Prof.</last_name>
      <phone>+49 1703042496</phone>
      <phone_ext>01703042496</phone_ext>
      <email>jgoerich@t-online.de</email>
    </contact>
    <contact_backup>
      <last_name>Sebastian J Buss, Prof.</last_name>
      <phone>+49 6221 316930</phone>
      <email>prof.buss@das-radiologische-zentrum.de</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <link>
    <url>https://www.das-radiologische-zentrum.de</url>
    <description>Website</description>
  </link>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>January 21, 2019</study_first_submitted>
  <study_first_submitted_qc>January 21, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 24, 2019</study_first_posted>
  <last_update_submitted>April 23, 2020</last_update_submitted>
  <last_update_submitted_qc>April 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Das Radiologische Zentrum</investigator_affiliation>
    <investigator_full_name>Johannes Görich</investigator_full_name>
    <investigator_title>Prof. Dr. med. Johannes Görich</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Stenosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03815123
org study id: S-758/2018
nct id: NCT03815123
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The aim of this Heidelberg Cardiac CT Registry (Register kardiale Computertomographie) is to
      assess the diagnostic and prognostic perfomance of cardiac CT exminations in a real-world
      patient population.
Anthropometric data, medical history and results of the CT examinations are collected in a
      database in order to adressing various scientific questions.
observational model: Cohort
time perspective: Prospective
measure: coronary CT angiography
time frame: 10 years
description: Evaluation of degree of coronary artery stenosis
measure: coronary CT angiography
time frame: 10 years
description: Assessment of coronary plaque composition
measure: Agreement with other imaging modalities
time frame: 10 years
description: Agreement with other imaging modalities
measure: Occurence of MACE
time frame: 10 years
description: Occurence of major adverse events
intervention type: Diagnostic Test
intervention name: cardiac CT
description: The cardiac CT examinations are indicated by the referring physician. The participation in this study has no influence on the further diagnostic and therapeutic regimen.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Johannes Goerich, Prof.
phone: +491703042496
email: jgoerich@t-online.de
last name: Sebastian J Buss, Prof.
phone: +49 6221 316930
email: prof.buss@das-radiologische-zentrum.de
facility: 
status: Recruiting
contact: 
contact backup: 
country: Germany
url: https://www.das-radiologische-zentrum.de
description: Website
responsible party type: Principal Investigator
investigator affiliation: Das Radiologische Zentrum
investigator full name: Johannes Görich
investigator title: Prof. Dr. med. Johannes Görich
mesh term: Coronary Stenosis
sharing ipd: Undecided