<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/NCT03786406</url>
  </required_header>
  <id_info>
    <org_study_id>NN2211-4423</org_study_id>
    <secondary_id>U1111-1207-2816</secondary_id>
    <nct_id>NCT03786406</nct_id>
  </id_info>
  <brief_title>An International Survey of the Occurrence of Diseases That Affects the Heart and Blood Vessels Among People With Type 2 Diabetes</brief_title>
  <acronym>EU-CAPTURE</acronym>
  <official_title>A Non-interventional Cross-sectional Study to Capture the Prevalence of Cardiovascular Disease in Patients With Type 2 Diabetes in Selected Countries in Europe</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Novo Nordisk A/S</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Novo Nordisk A/S</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to register the occurrence of cardiovascular disease among type 2&#xD;
      diabetes (T2DM) patients across five selected countries in Europe. Participants will be asked&#xD;
      to give information about their health. Participants will continue their normal way of life&#xD;
      and will not get any medication other than what has been prescribed to them by their doctor.&#xD;
      Participants' participation will be one day/one visit at study doctor. The study will last&#xD;
      for about 3 months in total.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 3, 2018</start_date>
  <completion_date type="Actual">May 31, 2019</completion_date>
  <primary_completion_date type="Actual">May 31, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Diagnosed with cerebrovascular disease: Ischaemic stroke, haemorrhagic stroke, stroke (unspecified) and/or transient ischaemic attack</measure>
    <time_frame>Day 1</time_frame>
    <description>Percentage of participants (Y/N).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Diagnosed with CVD: Myocardial infarction, stable coronary artery disease (SCAD) also referred as angina (pectoris), other ischaemic heart disease and/or past revascularisation procedures</measure>
    <time_frame>Day 1</time_frame>
    <description>Percentage of participants (Y/N).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Diagnosed with symptomatic heart failure: New York Heart Association Functional Classification (NYHA) (group IIIV) and/or left ventricular ejection fraction (LVEF) greater than or equal to 50 percent, LVEF 40-49 percent and LVEF less than 40 percent)</measure>
    <time_frame>Day 1</time_frame>
    <description>Percentage of participants (Y/N).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Diagnosed with asymptomatic heart failure</measure>
    <time_frame>Day 1</time_frame>
    <description>Percentage of participants (Y/N).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hospitalisation for heart failure</measure>
    <time_frame>Day 1</time_frame>
    <description>Percentage of participants (Y/N).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Diagnosed with cardiac arrhythmia: Atrial fibrillation or flutter, ventricular tachycardia and/or ventricular fibrillation</measure>
    <time_frame>Day 1</time_frame>
    <description>Percentage of participants (Y/N).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Diagnosed with aortic diseases: Aortic dissection, aortic aneurysms and/or thromboembolic aortic disease</measure>
    <time_frame>Day 1</time_frame>
    <description>Percentage of participants (Y/N).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Diagnosed with peripheral artery disease: Asymptomatic peripheral arterial disease (PAD) defined as Low Ankle-Brachial Index (less than 0.90) or pulse abolition, claudication, limb ischemia and/or non-traumatic amputation</measure>
    <time_frame>Day 1</time_frame>
    <description>Percentage of participants (Y/N).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Diagnosed with carotid artery disease</measure>
    <time_frame>Day 1</time_frame>
    <description>Percentage of participants (Y/N).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>High risk of CVD (above 20% over 10 years) according to the risk engine from the United Kingdom Prospective Diabetes Study (UKPDS)</measure>
    <time_frame>Day 1</time_frame>
    <description>Percentage of participants (Y/N).</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">2275</enrollment>
  <condition>Diabetes Mellitus, Type 2</condition>
  <arm_group>
    <arm_group_label>T2DM patients seen in routine practice</arm_group_label>
    <description>All anti-diabetic and cardiovascular (CV) medication will be prescribed at the physician's discretion under routine clinical practice conditions.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No treatment given</intervention_name>
    <description>No specific intervention is studied. All anti-diabetic and CV medication will be prescribed at the physician's discretion under routine clinical practice conditions.</description>
    <arm_group_label>T2DM patients seen in routine practice</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study population will consist of male and female adults diagnosed with (type 2 diabetes&#xD;
        mellitus (T2DM).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Signed informed consent obtained before any study-related activities (study-related&#xD;
             activities are any procedures related to recording of data according to protocol)&#xD;
&#xD;
          -  Male or female, age greater than or equal to 18 years at the time of signing informed&#xD;
             consent&#xD;
&#xD;
          -  Diagnosed with type 2 diabetes mellitus greater than or equal to 180 days prior to the&#xD;
             day of signing the informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous participation in this study. Participation is defined as having given&#xD;
             informed consent in this study&#xD;
&#xD;
          -  Diagnosed with Type 1 diabetes&#xD;
&#xD;
          -  Mental incapacity, unwillingness or language barriers precluding adequate&#xD;
             understanding or cooperation&#xD;
&#xD;
          -  Patients with known congenital heart disease/malformation&#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>Clinical Reporting Anchor and Disclosure (1452)</last_name>
    <role>Study Director</role>
    <affiliation>Novo Nordisk A/S</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Benatky nad Jizerou</city>
        <zip>29471</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Boskovice</city>
        <zip>68001</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Brandys nad Labem</city>
        <zip>25001</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Breclav</city>
        <zip>69002</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Chomutov</city>
        <zip>43004</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Hradec Kralove</city>
        <zip>50341</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Kromeriz</city>
        <zip>76701</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Olomouc</city>
        <zip>77900</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Orlova</city>
        <zip>73514</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Ostrava</city>
        <zip>70200</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Ostrava</city>
        <zip>71800</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Plzen</city>
        <zip>30100</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Praha</city>
        <zip>14000</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Chartres</city>
        <zip>28000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Courpière</city>
        <zip>63120</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Le Creusot</city>
        <zip>71200</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Lyon</city>
        <zip>69007</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Montélimar</city>
        <zip>26200</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Saint Saens</city>
        <zip>76680</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Sathonay-Camp</city>
        <zip>69580</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Strasbourg</city>
        <zip>67000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Tarare</city>
        <zip>69170</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Venissieux</city>
        <zip>69200</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Albano Laziale</city>
        <zip>00041</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Ariano Irpino</city>
        <zip>83031</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Bagno a Ripoli</city>
        <zip>50012</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Brindisi</city>
        <zip>72100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Catanzaro</city>
        <zip>88100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Fano</city>
        <zip>61032</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Ferrara</city>
        <zip>44123</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Firenze</city>
        <zip>50134</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Messina</city>
        <zip>98128</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Milano</city>
        <zip>20162</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Napoli</city>
        <zip>80121</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Negrar (VR)</city>
        <zip>37024</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Orvieto</city>
        <zip>05018</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Partinico (PA)</city>
        <zip>90047</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Ravenna</city>
        <zip>48121</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Roma</city>
        <zip>00161</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Rozzano (MI)</city>
        <zip>20089</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Savigliano (CN)</city>
        <zip>12038</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Czechia</country>
    <country>France</country>
    <country>Italy</country>
  </location_countries>
  <results_reference>
    <citation>Mosenzon O, Alguwaihes A, Leon JLA, Bayram F, Darmon P, Davis TME, Dieuzeide G, Eriksen KT, Hong T, Kaltoft MS, Lengyel C, Rhee NA, Russo GT, Shirabe S, Urbancova K, Vencio S; CAPTURE Study Investigators. CAPTURE: a multinational, cross-sectional study of cardiovascular disease prevalence in adults with type 2 diabetes across 13 countries. Cardiovasc Diabetol. 2021 Jul 27;20(1):154. doi: 10.1186/s12933-021-01344-0.</citation>
    <PMID>34315481</PMID>
  </results_reference>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>December 20, 2018</study_first_submitted>
  <study_first_submitted_qc>December 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 26, 2018</study_first_posted>
  <last_update_submitted>June 19, 2023</last_update_submitted>
  <last_update_submitted_qc>June 19, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 2023</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>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>According to the Novo Nordisk disclosure commitment on novonordisk-trials.com</ipd_description>
    <ipd_url>https://www.novonordisk-trials.com</ipd_url>
  </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/NCT03786406
org study id: NN2211-4423
secondary id: U1111-1207-2816
nct id: NCT03786406
lead sponsor: 
has dmc: No
is fda regulated device: No
The purpose of the study is to register the occurrence of cardiovascular disease among type 2
      diabetes (T2DM) patients across five selected countries in Europe. Participants will be asked
      to give information about their health. Participants will continue their normal way of life
      and will not get any medication other than what has been prescribed to them by their doctor.
      Participants' participation will be one day/one visit at study doctor. The study will last
      for about 3 months in total.
observational model: Other
time perspective: Prospective
measure: Diagnosed with cerebrovascular disease: Ischaemic stroke, haemorrhagic stroke, stroke (unspecified) and/or transient ischaemic attack
time frame: Day 1
description: Percentage of participants (Y/N).
measure: Diagnosed with CVD: Myocardial infarction, stable coronary artery disease (SCAD) also referred as angina (pectoris), other ischaemic heart disease and/or past revascularisation procedures
time frame: Day 1
description: Percentage of participants (Y/N).
measure: Diagnosed with symptomatic heart failure: New York Heart Association Functional Classification (NYHA) (group IIIV) and/or left ventricular ejection fraction (LVEF) greater than or equal to 50 percent, LVEF 40-49 percent and LVEF less than 40 percent)
time frame: Day 1
description: Percentage of participants (Y/N).
measure: Diagnosed with asymptomatic heart failure
time frame: Day 1
description: Percentage of participants (Y/N).
measure: Hospitalisation for heart failure
time frame: Day 1
description: Percentage of participants (Y/N).
measure: Diagnosed with cardiac arrhythmia: Atrial fibrillation or flutter, ventricular tachycardia and/or ventricular fibrillation
time frame: Day 1
description: Percentage of participants (Y/N).
measure: Diagnosed with aortic diseases: Aortic dissection, aortic aneurysms and/or thromboembolic aortic disease
time frame: Day 1
description: Percentage of participants (Y/N).
measure: Diagnosed with peripheral artery disease: Asymptomatic peripheral arterial disease (PAD) defined as Low Ankle-Brachial Index (less than 0.90) or pulse abolition, claudication, limb ischemia and/or non-traumatic amputation
time frame: Day 1
description: Percentage of participants (Y/N).
measure: Diagnosed with carotid artery disease
time frame: Day 1
description: Percentage of participants (Y/N).
measure: High risk of CVD (above 20% over 10 years) according to the risk engine from the United Kingdom Prospective Diabetes Study (UKPDS)
time frame: Day 1
description: Percentage of participants (Y/N).
arm group label: T2DM patients seen in routine practice
description: All anti-diabetic and cardiovascular (CV) medication will be prescribed at the physician's discretion under routine clinical practice conditions.
intervention type: Other
intervention name: No treatment given
description: No specific intervention is studied. All anti-diabetic and CV medication will be prescribed at the physician's discretion under routine clinical practice conditions.
arm group label: T2DM patients seen in routine practice
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Clinical Reporting Anchor and Disclosure (1452)
role: Study Director
affiliation: Novo Nordisk A/S
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country: Czechia
country: France
country: Italy
citation: Mosenzon O, Alguwaihes A, Leon JLA, Bayram F, Darmon P, Davis TME, Dieuzeide G, Eriksen KT, Hong T, Kaltoft MS, Lengyel C, Rhee NA, Russo GT, Shirabe S, Urbancova K, Vencio S; CAPTURE Study Investigators. CAPTURE: a multinational, cross-sectional study of cardiovascular disease prevalence in adults with type 2 diabetes across 13 countries. Cardiovasc Diabetol. 2021 Jul 27;20(1):154. doi: 10.1186/s12933-021-01344-0.
PMID: 34315481
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
sharing ipd: Yes
ipd description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
ipd url: https://www.novonordisk-trials.com