<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/NCT02993172</url>
  </required_header>
  <id_info>
    <org_study_id>CCHS</org_study_id>
    <nct_id>NCT02993172</nct_id>
  </id_info>
  <brief_title>The Copenhagen City Heart Study</brief_title>
  <acronym>CCHS</acronym>
  <official_title>The Copenhagen City Heart Study 'Østerbroundersøgelsen'</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bispebjerg Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bispebjerg Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The Copenhagen City Heart Study is an ongoing cardiovascular population study initiated in&#xD;
      1976 which has examined approximately 25,000 individuals from the general population. The&#xD;
      initial sample has been re-invited up to four times and supplemented by younger individuals.&#xD;
      The study includes questionnaires, clinical assessment and biomarkers. The population have&#xD;
      been followed in a number of outcome registries and more than 900 scientific papers have been&#xD;
      published.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Copenhagen City Heart Study, also known as &quot;Østerbroundersøgelsen&quot;, is a large&#xD;
      prospective cardio-vascular population study of 20,000 women and men that was launched in&#xD;
      1975 by Dr Peter Schnohr and Dr Gorm Jensen together with statistician Jørgen Nyboe and Prof.&#xD;
      A. Tybjærg Hansen.&#xD;
&#xD;
      The original purpose of the study was to focus on prevention of coronary heart disease and&#xD;
      stroke. During the years many other aspects have been added to the study: pulmonary diseases,&#xD;
      heart failure, arrhythmia, alcohol, arthrosis, eye diseases, allergy, epilepsia, dementia,&#xD;
      stress, vital exhaustion, social network, sleep-apnoe, ageing and genetics. In the fourth and&#xD;
      fifth wave of the examination echocardiography was included.&#xD;
&#xD;
      The Copenhagen City Heart Study has invited a random sample of the census population in an&#xD;
      area of central Copenhagen in five waves. The primary population was a random sample of&#xD;
      19,329 men and women 20-93 years old, drawn from a population of approximately 90,000&#xD;
      inhabitants aged 20 years or older living in a central part of Copenhagen (Østerbro). Using&#xD;
      the unique personal identification number (Central-Personal-Register-code), consisting of&#xD;
      date of birth and a registration number, the sample was age-stratified within 5-year age&#xD;
      groups, with the main emphasis on the age groups from 35 to 70 years. The total number of&#xD;
      participants invited to the first four examinations was: 19,329+500+3,000+1,062 = 23,891 men&#xD;
      and women. Of the original 14,223 examined at the first examination 3,092 (21.7%) have been&#xD;
      examined in all four examinations.&#xD;
&#xD;
      Follow-up of mortality and morbidity using the unique personal identification number is&#xD;
      performed by linkage to a number of nation-wide disease registries. Follow-up completion rate&#xD;
      is almost 100 percent (less than 0.1% have been lost to follow-up mainly through emigration),&#xD;
      which is very uncommon for large population studies.&#xD;
&#xD;
      Overview of the patients examined in the Copenhagen City Heart Study:&#xD;
&#xD;
        1. st exam: 1976-78, 19,329 invited, 14,223 (73.6%) attended&#xD;
&#xD;
        2. nd exam: 1981-83, 18,059 invited, 12,698 (71.2%) attended&#xD;
&#xD;
        3. rd exam: 1991-94, 16,563 invited, 10.135 (61.2%) attended&#xD;
&#xD;
        4. th exam: 2001-03,12,600 invited, 6,238 (49.5%) attended&#xD;
&#xD;
        5. th exam: 2011-2014, approx 10,000 invited, approx 5000 (50%) attended&#xD;
&#xD;
      The Copenhagen City Heart Study is governed by a Steering Committee. The data from the&#xD;
      Copenhagen City Heart Study is made available to researchers upon application to and approval&#xD;
      by the Steering Committee. The following constitute the Steering Committee:&#xD;
&#xD;
      Gorm Jensen and Peter Schnohr (initiators), Peter Lange, Eva Prescott, Børge Nordestgaard,&#xD;
      Morten Grønbæk, Anne Tybjærg Hansen, Stig Bojesen, Finn Gyntelberg, Jan Skov Jensen and&#xD;
      Merete Appleyard&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 1976</start_date>
  <primary_completion_date type="Actual">January 2014</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>Registry based disease outcomes, mainly cardiovascular, pulmonary and cancer outcomes</measure>
    <time_frame>Latest registry update december 31 2014</time_frame>
  </primary_outcome>
  <enrollment type="Actual">23891</enrollment>
  <condition>Coronary Heart Disease</condition>
  <condition>Stroke</condition>
  <condition>Heart Failure</condition>
  <condition>Cancer</condition>
  <condition>Myocardial Infarction</condition>
  <condition>Chronic Obstructive Pulmonary Disease</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Age.stratified random sample of the census population&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Background population living in a defined area of Copenhagen&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 9, 2016</study_first_submitted>
  <study_first_submitted_qc>December 14, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 15, 2016</study_first_posted>
  <last_update_submitted>December 14, 2016</last_update_submitted>
  <last_update_submitted_qc>December 14, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 15, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Bispebjerg Hospital</investigator_affiliation>
    <investigator_full_name>Eva Prescott</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases, Obstructive</mesh_term>
    <mesh_term>Pulmonary Disease, Chronic Obstructive</mesh_term>
    <mesh_term>Myocardial Infarction</mesh_term>
    <mesh_term>Heart Diseases</mesh_term>
    <mesh_term>Coronary Disease</mesh_term>
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Myocardial Ischemia</mesh_term>
    <mesh_term>Infarction</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/NCT02993172
org study id: CCHS
nct id: NCT02993172
lead sponsor: 
has dmc: No
The Copenhagen City Heart Study is an ongoing cardiovascular population study initiated in
      1976 which has examined approximately 25,000 individuals from the general population. The
      initial sample has been re-invited up to four times and supplemented by younger individuals.
      The study includes questionnaires, clinical assessment and biomarkers. The population have
      been followed in a number of outcome registries and more than 900 scientific papers have been
      published.
The Copenhagen City Heart Study, also known as "Østerbroundersøgelsen", is a large
      prospective cardio-vascular population study of 20,000 women and men that was launched in
      1975 by Dr Peter Schnohr and Dr Gorm Jensen together with statistician Jørgen Nyboe and Prof.
      A. Tybjærg Hansen.

      The original purpose of the study was to focus on prevention of coronary heart disease and
      stroke. During the years many other aspects have been added to the study: pulmonary diseases,
      heart failure, arrhythmia, alcohol, arthrosis, eye diseases, allergy, epilepsia, dementia,
      stress, vital exhaustion, social network, sleep-apnoe, ageing and genetics. In the fourth and
      fifth wave of the examination echocardiography was included.

      The Copenhagen City Heart Study has invited a random sample of the census population in an
      area of central Copenhagen in five waves. The primary population was a random sample of
      19,329 men and women 20-93 years old, drawn from a population of approximately 90,000
      inhabitants aged 20 years or older living in a central part of Copenhagen (Østerbro). Using
      the unique personal identification number (Central-Personal-Register-code), consisting of
      date of birth and a registration number, the sample was age-stratified within 5-year age
      groups, with the main emphasis on the age groups from 35 to 70 years. The total number of
      participants invited to the first four examinations was: 19,329+500+3,000+1,062 = 23,891 men
      and women. Of the original 14,223 examined at the first examination 3,092 (21.7%) have been
      examined in all four examinations.

      Follow-up of mortality and morbidity using the unique personal identification number is
      performed by linkage to a number of nation-wide disease registries. Follow-up completion rate
      is almost 100 percent (less than 0.1% have been lost to follow-up mainly through emigration),
      which is very uncommon for large population studies.

      Overview of the patients examined in the Copenhagen City Heart Study:

        1. st exam: 1976-78, 19,329 invited, 14,223 (73.6%) attended

        2. nd exam: 1981-83, 18,059 invited, 12,698 (71.2%) attended

        3. rd exam: 1991-94, 16,563 invited, 10.135 (61.2%) attended

        4. th exam: 2001-03,12,600 invited, 6,238 (49.5%) attended

        5. th exam: 2011-2014, approx 10,000 invited, approx 5000 (50%) attended

      The Copenhagen City Heart Study is governed by a Steering Committee. The data from the
      Copenhagen City Heart Study is made available to researchers upon application to and approval
      by the Steering Committee. The following constitute the Steering Committee:

      Gorm Jensen and Peter Schnohr (initiators), Peter Lange, Eva Prescott, Børge Nordestgaard,
      Morten Grønbæk, Anne Tybjærg Hansen, Stig Bojesen, Finn Gyntelberg, Jan Skov Jensen and
      Merete Appleyard
observational model: Cohort
time perspective: Prospective
measure: Registry based disease outcomes, mainly cardiovascular, pulmonary and cancer outcomes
time frame: Latest registry update december 31 2014
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Bispebjerg Hospital
investigator full name: Eva Prescott
investigator title: Professor
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive
mesh term: Myocardial Infarction
mesh term: Heart Diseases
mesh term: Coronary Disease
mesh term: Coronary Artery Disease
mesh term: Myocardial Ischemia
mesh term: Infarction