<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/NCT04450459</url>
  </required_header>
  <id_info>
    <org_study_id>SMW 08</org_study_id>
    <nct_id>NCT04450459</nct_id>
  </id_info>
  <brief_title>Impact of Spiroergometer Parameters as Diagnostic Marker of Cardiac Ischemia in Pts. With Stable Angina Compared to FFR.</brief_title>
  <acronym>ADVANCE</acronym>
  <official_title>Impact of Ergospirometric Oxygen Uptake Under Exercise as Diagnostic Marker of Cardiac Ischemia in Patients With Stable Angina Compared to Non Invasive and Invasive (FFR) Measurement of Ischemia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jena University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Jena University Hospital</source>
  <brief_summary>
    <textblock>
      In Patients with stable Angina pectoris CCS 1-3 exercise testing for ischemia detection is&#xD;
      widely used despite the known limitations. Measurement of the FFR is invasive but gold&#xD;
      standard for Ischemia detection.&#xD;
&#xD;
      Adding of parameters of spiroergometer might help to improve diagnostic accuracy of non&#xD;
      invasive exercise testing. Therefore the trial is evaluating diagnostic accuracy of&#xD;
      spiroergometric parameters compared to invasive FFR measurement.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 2, 2019</start_date>
  <completion_date type="Anticipated">June 2023</completion_date>
  <primary_completion_date type="Anticipated">January 2023</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>double slope sign of ΔV̇O2/ΔWR-Increase</measure>
    <time_frame>baseline</time_frame>
    <description>double slope sign of ΔV̇O2/ΔWR by ergospirometer test</description>
  </primary_outcome>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Stable Angina</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>ergospirometer test</intervention_name>
    <description>ergospirometric test will be done before cardiac catheterisation and invasive measurement of FFR</description>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      EDTA Blood, Serum,&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        patients with suspected CAD presenting for diagnostic testing/ coronary angiography&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  stable Angina (CCS &gt;1-3) with suspected CAD or&#xD;
&#xD;
          -  dyspnoea at exertion NYHA &gt;2 or&#xD;
&#xD;
          -  signs of ischemia within SPECT or exercise electrocardiography&#xD;
&#xD;
          -  willingness to participate in the trial&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unstable angina or myocardial infarction within the last 2 weeks&#xD;
&#xD;
          -  inability to perform bicycle exercise test&#xD;
&#xD;
          -  significant valvular disease&#xD;
&#xD;
          -  HOCM&#xD;
&#xD;
          -  av- block &gt;I degree&#xD;
&#xD;
          -  asthma bronchiales&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Sven Möbius-Winkler, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universityhospital Jena</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sven Möbius-Winkler, MD</last_name>
    <phone>0049-3641-9324503</phone>
    <email>Sven.Moebius-Winkler@med.uni-jena.de</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Sissy Grund</last_name>
    <email>sissy.grun@med.uni-jena.de</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Universityhospital</name>
      <address>
        <city>Jena</city>
        <zip>07747</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sven Möbius-Winkler</last_name>
      <email>Sven.Moebius-Winkler@med.uni-jena.de</email>
    </contact>
    <contact_backup>
      <last_name>Sissy Grund</last_name>
      <email>sissy.grund@med.uni-jena.de</email>
    </contact_backup>
    <investigator>
      <last_name>Nedim Memisevic, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>David Hanke, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Ulf Teichgräber, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>June 25, 2020</study_first_submitted>
  <study_first_submitted_qc>June 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 29, 2020</study_first_posted>
  <last_update_submitted>August 10, 2022</last_update_submitted>
  <last_update_submitted_qc>August 10, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 11, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>FFR Measurement; exercise testing, ergospirometer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Angina Pectoris</mesh_term>
    <mesh_term>Angina, Stable</mesh_term>
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Myocardial Ischemia</mesh_term>
    <mesh_term>Ischemia</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/NCT04450459
org study id: SMW 08
nct id: NCT04450459
lead sponsor: 
In Patients with stable Angina pectoris CCS 1-3 exercise testing for ischemia detection is
      widely used despite the known limitations. Measurement of the FFR is invasive but gold
      standard for Ischemia detection.

      Adding of parameters of spiroergometer might help to improve diagnostic accuracy of non
      invasive exercise testing. Therefore the trial is evaluating diagnostic accuracy of
      spiroergometric parameters compared to invasive FFR measurement.
observational model: Cohort
time perspective: Prospective
measure: double slope sign of ΔV̇O2/ΔWR-Increase
time frame: baseline
description: double slope sign of ΔV̇O2/ΔWR by ergospirometer test
intervention type: Diagnostic Test
intervention name: ergospirometer test
description: ergospirometric test will be done before cardiac catheterisation and invasive measurement of FFR
EDTA Blood, Serum,
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: Sven Möbius-Winkler, MD
role: Principal Investigator
affiliation: Universityhospital Jena
last name: Sven Möbius-Winkler, MD
phone: 0049-3641-9324503
email: Sven.Moebius-Winkler@med.uni-jena.de
last name: Sissy Grund
email: sissy.grun@med.uni-jena.de
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
country: Germany
responsible party type: Sponsor
mesh term: Angina Pectoris
mesh term: Angina, Stable
mesh term: Coronary Artery Disease
mesh term: Myocardial Ischemia
mesh term: Ischemia
sharing ipd: No