<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/NCT02984280</url>
  </required_header>
  <id_info>
    <org_study_id>15/0440</org_study_id>
    <nct_id>NCT02984280</nct_id>
  </id_info>
  <brief_title>Specific Respiratory Infections as Triggers of Acute Medical Events</brief_title>
  <official_title>Specific Respiratory Infections as Triggers of Acute Medical Events: Time Series Analysis Using LabBase and Hospital Episode Statistics</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University College, London</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Public Health England</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>
      This study will investigate whether there is a population-level association between&#xD;
      circulating respiratory viruses and NHS hospital admissions for acute vascular events using&#xD;
      data from national infection surveillance and Hospital Episode Statistics.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      We will conduct a time series study correlating anonymised population level data on all&#xD;
      samples from NHS laboratories testing positive for six common respiratory viruses with&#xD;
      admissions to NHS hospitals in England for a range of cardiac and vascular outcomes over the&#xD;
      time period 01/01/2004 to 31/12/2014. This will involve generating Poisson regression models&#xD;
      controlling for factors such as seasonal and long-term trends, environmental temperature and&#xD;
      humidity.&#xD;
&#xD;
      This study is funded by an Academy of Medical Sciences Starter Grant for Clinical Lecturers.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2016</start_date>
  <completion_date type="Actual">March 2017</completion_date>
  <primary_completion_date type="Actual">March 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Ecologic or Community</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Acute myocardial infarction</measure>
    <time_frame>01/01/2004 to 31/12/2014</time_frame>
    <description>ICD-10 coded</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Stroke</measure>
    <time_frame>01/01/2004 to 31/12/2014</time_frame>
    <description>ICD-10 coded</description>
  </primary_outcome>
  <enrollment type="Actual">787000</enrollment>
  <condition>Influenza, Human</condition>
  <condition>Respiratory Syncytial Virus Infections</condition>
  <condition>Parainfluenza</condition>
  <condition>Rhinovirus</condition>
  <condition>Adenovirus</condition>
  <condition>Human Metapneumovirus Pneumonia</condition>
  <condition>Cardiovascular Diseases</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Adult population of England who have received NHS care during the study period.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Any individual with a record of an eligible outcome (ICD-10 coded hospitalisation for&#xD;
             myocardial infarction or stroke) within the study period aged 45+ years&#xD;
&#xD;
          -  Any individual with a record of an eligible exposure (laboratory-confirmed respiratory&#xD;
             virus) within the study period at any age&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Outcome events occurring in people aged &lt;45 years&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Charlotte MJ Warren-Gash, MRCP PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UCL</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University College London (UCL)</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>November 2016</verification_date>
  <study_first_submitted>December 2, 2016</study_first_submitted>
  <study_first_submitted_qc>December 2, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 6, 2016</study_first_posted>
  <last_update_submitted>May 3, 2017</last_update_submitted>
  <last_update_submitted_qc>May 3, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 4, 2017</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>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Respiratory Tract Infections</mesh_term>
    <mesh_term>Respiratory Syncytial Virus Infections</mesh_term>
    <mesh_term>Influenza, Human</mesh_term>
    <mesh_term>Paramyxoviridae Infections</mesh_term>
    <mesh_term>Cardiovascular Diseases</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/NCT02984280
org study id: 15/0440
nct id: NCT02984280
lead sponsor: 
collaborator: 
has dmc: No
This study will investigate whether there is a population-level association between
      circulating respiratory viruses and NHS hospital admissions for acute vascular events using
      data from national infection surveillance and Hospital Episode Statistics.
We will conduct a time series study correlating anonymised population level data on all
      samples from NHS laboratories testing positive for six common respiratory viruses with
      admissions to NHS hospitals in England for a range of cardiac and vascular outcomes over the
      time period 01/01/2004 to 31/12/2014. This will involve generating Poisson regression models
      controlling for factors such as seasonal and long-term trends, environmental temperature and
      humidity.

      This study is funded by an Academy of Medical Sciences Starter Grant for Clinical Lecturers.
observational model: Ecologic or Community
time perspective: Retrospective
measure: Acute myocardial infarction
time frame: 01/01/2004 to 31/12/2014
description: ICD-10 coded
measure: Stroke
time frame: 01/01/2004 to 31/12/2014
description: ICD-10 coded
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 45 Years
maximum age: N/A
healthy volunteers: No
last name: Charlotte MJ Warren-Gash, MRCP PhD
role: Principal Investigator
affiliation: UCL
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Respiratory Tract Infections
mesh term: Respiratory Syncytial Virus Infections
mesh term: Influenza, Human
mesh term: Paramyxoviridae Infections
mesh term: Cardiovascular Diseases