<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/NCT02244853</url>
  </required_header>
  <id_info>
    <org_study_id>12_153R_IP24</org_study_id>
    <secondary_id>086091/Z/08/Z</secondary_id>
    <secondary_id>RP-PG-0407-10314</secondary_id>
    <nct_id>NCT02244853</nct_id>
  </id_info>
  <brief_title>Heart Rate and Cardiovascular Diseases Prognosis in People With Stable Coronary Artery Disease</brief_title>
  <official_title>Association of Heart Rate With Cardiovascular Disease Prognosis of Patients With Stable Coronary Artery Disease: A CALIBER Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University College, London</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Wellcome Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute for Health Research, United Kingdom</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University College, London</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The Cardiovascular disease research using Linked Bespoke studies and Electronic Records&#xD;
      (CALIBER) e-health database was the data resource for this study. CALIBER links patient&#xD;
      records from four different data sources: Clinical Practice Research Database (CPRD), MINAP&#xD;
      (Myocardial Ischaemia National Audit Project registry) Hospital Episodes Statistics (HES),&#xD;
      the Office for National Statistics (ONS).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is part of the CALIBER (Cardiovascular disease research using linked bespoke&#xD;
      studies and electronic records) programme funded over 5 years from the NIHR and Wellcome&#xD;
      Trust. The central theme of the CALIBER research is linkage of the Myocardial Ischaemia&#xD;
      National Audit Project (MINAP) with primary care (GPRD) and other resources. The overarching&#xD;
      aim of CALIBER is to better understand the aetiology and prognosis of specific coronary&#xD;
      phenotypes across a range of causal domains, particularly where electronic records provide a&#xD;
      contribution beyond traditional studies. CALIBER has received both Ethics approval (ref&#xD;
      09/H0810/16) and ECC approval (ref ECC 2-06(b)/2009 CALIBER dataset).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>September 2013</start_date>
  <completion_date type="Anticipated">December 2014</completion_date>
  <primary_completion_date type="Actual">December 2013</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>Risk of cardiovascular diseases in patients with low and high heart rate and stable coronary artery disease</measure>
    <time_frame>expected average of 3 years</time_frame>
    <description>Participants were followed until their first cardiovascular or complication event after their studyentry and after at least one previous cardiovascular event. Hazard ratios will be presenting associations between heart rate (analysed as quintiles and as continuous per 10bpm) and 8 different cardiovascular diseases (including mortality outcomes, complications such as bleeding events and composite cerebrovascular and coronary heart disease endpoints).</description>
  </primary_outcome>
  <enrollment type="Actual">51703</enrollment>
  <condition>Stable Angina</condition>
  <condition>Myocardial Infarction</condition>
  <condition>Coronary Heart Disease</condition>
  <condition>Heart Failure</condition>
  <condition>Stroke</condition>
  <condition>Death, Sudden, Cardiac</condition>
  <condition>Peripheral Arterial Disease</condition>
  <condition>Atrial Fibrillation</condition>
  <condition>Bleeding</condition>
  <eligibility>
    <study_pop>
      <textblock>
        An open cohort of 2,23 million people covering approximately 5% of the UK population was&#xD;
        drawn from registrants to 225 GP practices who consented to data linkage.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged &gt;=30 years at study entry -&gt;=1 year registration prior to the 'index date'&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Free from previous atherosclerotic events&#xD;
&#xD;
          -  No heart rate measurement after their 'index date' of eligibility to entry the study&#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_official>
    <last_name>Harry Hemingway, Professor</last_name>
    <role>Study Director</role>
    <affiliation>Farr Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Farr Institute, University College London</name>
      <address>
        <city>London</city>
        <zip>NW1 2DA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 17, 2014</study_first_submitted>
  <study_first_submitted_qc>September 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2014</study_first_posted>
  <last_update_submitted>September 18, 2014</last_update_submitted>
  <last_update_submitted_qc>September 18, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 19, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University College, London</investigator_affiliation>
    <investigator_full_name>Harry Hemingway</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>Atrial Fibrillation</mesh_term>
    <mesh_term>Cardiovascular Diseases</mesh_term>
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Coronary Disease</mesh_term>
    <mesh_term>Myocardial Infarction</mesh_term>
    <mesh_term>Peripheral Arterial Disease</mesh_term>
    <mesh_term>Peripheral Vascular Diseases</mesh_term>
    <mesh_term>Angina, Stable</mesh_term>
    <mesh_term>Death, Sudden, Cardiac</mesh_term>
    <mesh_term>Death, Sudden</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/NCT02244853
org study id: 12_153R_IP24
secondary id: 086091/Z/08/Z
secondary id: RP-PG-0407-10314
nct id: NCT02244853
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The Cardiovascular disease research using Linked Bespoke studies and Electronic Records
      (CALIBER) e-health database was the data resource for this study. CALIBER links patient
      records from four different data sources: Clinical Practice Research Database (CPRD), MINAP
      (Myocardial Ischaemia National Audit Project registry) Hospital Episodes Statistics (HES),
      the Office for National Statistics (ONS).
This study is part of the CALIBER (Cardiovascular disease research using linked bespoke
      studies and electronic records) programme funded over 5 years from the NIHR and Wellcome
      Trust. The central theme of the CALIBER research is linkage of the Myocardial Ischaemia
      National Audit Project (MINAP) with primary care (GPRD) and other resources. The overarching
      aim of CALIBER is to better understand the aetiology and prognosis of specific coronary
      phenotypes across a range of causal domains, particularly where electronic records provide a
      contribution beyond traditional studies. CALIBER has received both Ethics approval (ref
      09/H0810/16) and ECC approval (ref ECC 2-06(b)/2009 CALIBER dataset).
observational model: Cohort
time perspective: Prospective
measure: Risk of cardiovascular diseases in patients with low and high heart rate and stable coronary artery disease
time frame: expected average of 3 years
description: Participants were followed until their first cardiovascular or complication event after their studyentry and after at least one previous cardiovascular event. Hazard ratios will be presenting associations between heart rate (analysed as quintiles and as continuous per 10bpm) and 8 different cardiovascular diseases (including mortality outcomes, complications such as bleeding events and composite cerebrovascular and coronary heart disease endpoints).
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: Harry Hemingway, Professor
role: Study Director
affiliation: Farr Institute
facility: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: University College, London
investigator full name: Harry Hemingway
investigator title: Professor
mesh term: Atrial Fibrillation
mesh term: Cardiovascular Diseases
mesh term: Coronary Artery Disease
mesh term: Coronary Disease
mesh term: Myocardial Infarction
mesh term: Peripheral Arterial Disease
mesh term: Peripheral Vascular Diseases
mesh term: Angina, Stable
mesh term: Death, Sudden, Cardiac
mesh term: Death, Sudden