<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/NCT03749694</url>
  </required_header>
  <id_info>
    <org_study_id>PG/13/81/30474_STEMI</org_study_id>
    <nct_id>NCT03749694</nct_id>
  </id_info>
  <brief_title>Investigating Temporal Improvements in Survival Following ST-elevation Myocardial Infarction.</brief_title>
  <official_title>Investigating Temporal Improvements in Survival Following ST-elevation Myocardial Infarction: A Causal Mediation Analysis Using the Myocardial Ischaemia National Audit Project, 2004-2013.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Leeds</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Leeds</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the study was to use data from the Myocardial Ischaemia National Audit Project&#xD;
      (MINAP) to investigate whether temporal improvements in survival were associated with changes&#xD;
      in patients' baseline clinical risk or use of guideline-indicated treatments for the&#xD;
      management of STEMI, and to determine the extent to which associations explained the temporal&#xD;
      improvements in survival.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2004</start_date>
  <completion_date type="Actual">June 30, 2013</completion_date>
  <primary_completion_date type="Actual">June 30, 2013</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>7 Years</target_duration>
  <primary_outcome>
    <measure>All cause mortality</measure>
    <time_frame>one year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>All cause mortality</measure>
    <time_frame>six months</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">232353</enrollment>
  <condition>Acute Myocardial Infarction</condition>
  <eligibility>
    <study_pop>
      <textblock>
        The study population comprised of 232,353 in hospital survivors of ST-elevation myocardial&#xD;
        infarction recorded in the Myocardial Ischaemia National Audit Project registry between&#xD;
        2004 and June 2013.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  aged 18 years or more&#xD;
&#xD;
          -  patients hospitalised with ST-elevation myocardial infarction&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients hospitalised with phenotypes other than ST-elevation myocardial infarction&#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>Chris P Gale, FRCP</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Leeds</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Tatendashe B Dondo, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Leeds</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Marlous Hall, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Leeds</affiliation>
  </overall_official>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 20, 2018</study_first_submitted>
  <study_first_submitted_qc>November 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 21, 2018</study_first_posted>
  <last_update_submitted>November 20, 2018</last_update_submitted>
  <last_update_submitted_qc>November 20, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 21, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Leeds</investigator_affiliation>
    <investigator_full_name>Tatendashe Bernadette Dondo</investigator_full_name>
    <investigator_title>Postdoctoral medical statistician</investigator_title>
  </responsible_party>
  <keyword>Acute Myocardial Infarction</keyword>
  <keyword>mortality</keyword>
  <keyword>evidence-based care</keyword>
  <keyword>Myocardial Ischaemia National Audit Project</keyword>
  <keyword>ST-elevation myocardial infarction</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myocardial Infarction</mesh_term>
    <mesh_term>Myocardial Ischemia</mesh_term>
    <mesh_term>ST Elevation Myocardial Infarction</mesh_term>
    <mesh_term>Infarction</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03749694
org study id: PG/13/81/30474_STEMI
nct id: NCT03749694
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of the study was to use data from the Myocardial Ischaemia National Audit Project
      (MINAP) to investigate whether temporal improvements in survival were associated with changes
      in patients' baseline clinical risk or use of guideline-indicated treatments for the
      management of STEMI, and to determine the extent to which associations explained the temporal
      improvements in survival.
observational model: Cohort
time perspective: Prospective
measure: All cause mortality
time frame: one year
measure: All cause mortality
time frame: six months
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Chris P Gale, FRCP
role: Principal Investigator
affiliation: University of Leeds
last name: Tatendashe B Dondo, PhD
role: Principal Investigator
affiliation: University of Leeds
last name: Marlous Hall, PhD
role: Principal Investigator
affiliation: University of Leeds
responsible party type: Principal Investigator
investigator affiliation: University of Leeds
investigator full name: Tatendashe Bernadette Dondo
investigator title: Postdoctoral medical statistician
mesh term: Myocardial Infarction
mesh term: Myocardial Ischemia
mesh term: ST Elevation Myocardial Infarction
mesh term: Infarction
sharing ipd: No