<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/NCT01692795</url>
  </required_header>
  <id_info>
    <org_study_id>CALIBER_EH3</org_study_id>
    <secondary_id>086091/Z/08/Z</secondary_id>
    <nct_id>NCT01692795</nct_id>
  </id_info>
  <brief_title>Cardiovascular Medication Use Before First Myocardial Infarction</brief_title>
  <official_title>Cardiovascular Medication Prescriptions Before First Myocardial Infarction in Patients With and Without Previously Diagnosed Atherosclerotic Disease: an Analysis of Linked Prospectively Collected Electronic Healthcare Records</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>London School of Hygiene and Tropical Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University College, London</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>London School of Hygiene and Tropical Medicine</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Large randomised trials have shown that cardiovascular medications prescribed to patients at&#xD;
      high cardiovascular risk are effective in reducing the incidence of cardiovascular events.&#xD;
      Their use is recommended in the United Kingdom and international guidelines (e.g. the&#xD;
      National Institute of Clinical Excellence). However, these medications do not prevent&#xD;
      cardiovascular events in all patients and there is now a body of research investigating the&#xD;
      effects of cardiovascular medications on outcomes in myocardial infarction (MI), including&#xD;
      clinical presentation, infarct size and post-MI mortality. However, the independent effects&#xD;
      of cardiovascular drugs on post-MI all cause mortality are unclear, and there are limitations&#xD;
      to many of the published studies in terms of their cardiovascular drug exposure data. This&#xD;
      project utilizes prospectively collected data on cardiovascular drug use, and links to MI&#xD;
      data from hospital and mortality records.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2009</start_date>
  <completion_date type="Actual">September 2013</completion_date>
  <primary_completion_date type="Actual">September 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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>All cause mortality</measure>
    <time_frame>Up to seven years</time_frame>
    <description>All cause mortality, using Office for National Statistics (ONS) mortality statistics</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Re-infarction</measure>
    <time_frame>One year after initial myocardial infarction</time_frame>
    <description>Reinfarction will be measured based on data from the General Practice Research Database (GPRD), Hospital Episode Statistics (HES), the Myocardial Ischaemia National Audit Project (MINAP) and Office for National Statistics (ONS) mortality data.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Myocardial infarciton (MI) type</measure>
    <time_frame>Measured at baseline</time_frame>
    <description>Diagnosed ST-elevation MI or non ST-elevation myocardial infarction</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Infarct size</measure>
    <time_frame>Measured at baseline</time_frame>
    <description>Infarct size, as measured by levels of peak troponin in hospital, as recorded in the MINAP data source.</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">17000</enrollment>
  <condition>Myocardial Infarction</condition>
  <arm_group>
    <arm_group_label>MI patients</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        The study population is comprised of patients with a first myocardial infarction who are&#xD;
        registered at those General Practice Research Database (GPRD) practices that agreed to the&#xD;
        linkage with the MINAP database, and whose practices are &quot;up to standard&quot; according to GPRD&#xD;
        criteria. Practices taking part in the GPRD are chosen to be representative of all United&#xD;
        Kingdom (UK) practices, and 98% of people in the UK are registered with a General&#xD;
        Practitioner (GP). Therefore the GPRD should be a representative sample of the UK&#xD;
        population.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients in GPRD practices which are deemed &quot;up to standard&quot; by GPRD criteria will be&#xD;
        included if their practice agreed to be linked to the Myocardial Ischaemic National Audit&#xD;
        Project (MINAP), Hospital Episode Statistics (HES) and Office for National Statistics (ONS)&#xD;
        datasets.&#xD;
&#xD;
        Patients must have at least one year of GPRD &quot;up to standard&quot; registration before the date&#xD;
        of first myocardial infarction.&#xD;
&#xD;
        Age over 18. First myocardial infarction occurring between 1st January 2003 and 31st&#xD;
        December 2008, as recorded in the HES data or MINAP.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients will be excluded if they do not fulfil one of the inclusion criteria.&#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>Emily Herrett, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>London School of Hygiene and Tropical Medicine</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Harry Hemingway, FRCP</last_name>
    <role>Study Director</role>
    <affiliation>University College, London</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>London School of Hygiene and Tropical Medicine</name>
      <address>
        <city>London</city>
        <zip>WC1E 7HT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>October 2015</verification_date>
  <study_first_submitted>September 21, 2012</study_first_submitted>
  <study_first_submitted_qc>September 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2012</study_first_posted>
  <last_update_submitted>October 1, 2015</last_update_submitted>
  <last_update_submitted_qc>October 1, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 2, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>London School of Hygiene and Tropical Medicine</investigator_affiliation>
    <investigator_full_name>Emily Herrett</investigator_full_name>
    <investigator_title>Principle Investigator</investigator_title>
  </responsible_party>
  <keyword>Myocardial infarction</keyword>
  <keyword>Antiplatelets</keyword>
  <keyword>Lipid lowering agents</keyword>
  <keyword>ACE inhibitors</keyword>
  <keyword>Angiotensin Receptor Blockers</keyword>
  <keyword>Beta blockers</keyword>
  <keyword>Blood pressure lowering drugs</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myocardial Infarction</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/NCT01692795
org study id: CALIBER_EH3
secondary id: 086091/Z/08/Z
nct id: NCT01692795
lead sponsor: 
collaborator: 
has dmc: Yes
Large randomised trials have shown that cardiovascular medications prescribed to patients at
      high cardiovascular risk are effective in reducing the incidence of cardiovascular events.
      Their use is recommended in the United Kingdom and international guidelines (e.g. the
      National Institute of Clinical Excellence). However, these medications do not prevent
      cardiovascular events in all patients and there is now a body of research investigating the
      effects of cardiovascular medications on outcomes in myocardial infarction (MI), including
      clinical presentation, infarct size and post-MI mortality. However, the independent effects
      of cardiovascular drugs on post-MI all cause mortality are unclear, and there are limitations
      to many of the published studies in terms of their cardiovascular drug exposure data. This
      project utilizes prospectively collected data on cardiovascular drug use, and links to MI
      data from hospital and mortality records.
observational model: Cohort
time perspective: Retrospective
measure: All cause mortality
time frame: Up to seven years
description: All cause mortality, using Office for National Statistics (ONS) mortality statistics
measure: Re-infarction
time frame: One year after initial myocardial infarction
description: Reinfarction will be measured based on data from the General Practice Research Database (GPRD), Hospital Episode Statistics (HES), the Myocardial Ischaemia National Audit Project (MINAP) and Office for National Statistics (ONS) mortality data.
measure: Myocardial infarciton (MI) type
time frame: Measured at baseline
description: Diagnosed ST-elevation MI or non ST-elevation myocardial infarction
measure: Infarct size
time frame: Measured at baseline
description: Infarct size, as measured by levels of peak troponin in hospital, as recorded in the MINAP data source.
arm group label: MI patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Emily Herrett, MSc
role: Principal Investigator
affiliation: London School of Hygiene and Tropical Medicine
last name: Harry Hemingway, FRCP
role: Study Director
affiliation: University College, London
facility: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: London School of Hygiene and Tropical Medicine
investigator full name: Emily Herrett
investigator title: Principle Investigator
mesh term: Myocardial Infarction
mesh term: Infarction