<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/NCT03037255</url>
  </required_header>
  <id_info>
    <org_study_id>UoL_LTC</org_study_id>
    <nct_id>NCT03037255</nct_id>
  </id_info>
  <brief_title>Association of Long-term Conditions With Survival Following Heart Attack in England and Wales</brief_title>
  <official_title>Association of Long-term Conditions With Survival Following Acute Myocardial Infarction in England and Wales</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Marlous Hall</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Leeds</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to determine the extent to which pre-existing long-term conditions are&#xD;
      associated with survival following a heart attack (acute myocardial infarction) using&#xD;
      observational data from the UK's national heart attack register.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Using observational data from the Myocardial Ischaemia National Audit Project (MINAP) of all&#xD;
      hospitalisations for acute myocardial infarction in all acute hospitals in England and Wales,&#xD;
      this study aims to determine the extent to which pre-existing long-term conditions are&#xD;
      associated with survival following acute myocardial infarction. The study will include an&#xD;
      investigation of individual long term conditions for patients with acute myocardial&#xD;
      infarction, including chronic heart failure, cerebrovascular disease, diabetes mellitus,&#xD;
      chronic obstructive pulmonary disease, chronic renal failure or peripheral vascular disease&#xD;
      as well as the combination of such conditions and their resulting impact on long term&#xD;
      all-cause mortality (up to 8.4 years). In addition, an investigation of the association of&#xD;
      receipt of guideline recommended care for acute myocardial infarction patients with&#xD;
      pre-existing long term conditions will be made.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2003</start_date>
  <completion_date type="Actual">January 2021</completion_date>
  <primary_completion_date type="Actual">December 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>8 Years</target_duration>
  <primary_outcome>
    <measure>Number of patients who died from any cause by the end of the study censoring period</measure>
    <time_frame>8.4 years</time_frame>
    <description>Death data was obtained from national death records from the Office for National Statistics</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of patients who received guideline recommended therapy during the study period</measure>
    <time_frame>Any guideline therapy administered during the patients hospital admission for acute myocardial infarction, an average of 4 days</time_frame>
    <description>All guideline recommended therapies for acute myocardial infarction relevant to the duration of the study period (2003 to 2013) will be assessed.</description>
  </secondary_outcome>
  <enrollment type="Actual">693633</enrollment>
  <condition>Acute Myocardial Infarction</condition>
  <condition>Diabetes Mellitus</condition>
  <condition>Peripheral Vascular Disease</condition>
  <condition>Chronic Heart Failure</condition>
  <condition>Cerebrovascular Disease</condition>
  <condition>Chronic Renal Failure</condition>
  <condition>Chronic Obstructive Pulmonary Disease</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>long term conditions</intervention_name>
    <description>Long term conditions including diabetes mellitus, chronic obstructive pulmonary disease or asthma, chronic heart failure, chronic renal failure, cerebrovascular disease or peripheral vascular disease.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with ST-segment elevation myocardial infarction (STEMI) or non-STEMI (NSTEMI)&#xD;
        admitted to one of 247 hospitals in England and Wales between 1st January 2003 and 30th&#xD;
        June 2013&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients must be 18 years or older&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients for which mortality data are missing&#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 Gale, PhD, FRCP</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Leeds</affiliation>
  </overall_official>
  <link>
    <url>https://medicinehealth.leeds.ac.uk/medicine/staff/390/dr-marlous-hall</url>
    <description>Principal Researchers Profile Page</description>
  </link>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>January 24, 2017</study_first_submitted>
  <study_first_submitted_qc>January 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 31, 2017</study_first_posted>
  <last_update_submitted>May 17, 2022</last_update_submitted>
  <last_update_submitted_qc>May 17, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 24, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Leeds</investigator_affiliation>
    <investigator_full_name>Marlous Hall</investigator_full_name>
    <investigator_title>Co-Investigator</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>Cerebrovascular Disorders</mesh_term>
    <mesh_term>Kidney Failure, Chronic</mesh_term>
    <mesh_term>Myocardial Infarction</mesh_term>
    <mesh_term>Vascular Diseases</mesh_term>
    <mesh_term>Peripheral Vascular Diseases</mesh_term>
    <mesh_term>Peripheral Arterial Disease</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/NCT03037255
org study id: UoL_LTC
nct id: NCT03037255
lead sponsor: 
has dmc: No
This study aims to determine the extent to which pre-existing long-term conditions are
      associated with survival following a heart attack (acute myocardial infarction) using
      observational data from the UK's national heart attack register.
Using observational data from the Myocardial Ischaemia National Audit Project (MINAP) of all
      hospitalisations for acute myocardial infarction in all acute hospitals in England and Wales,
      this study aims to determine the extent to which pre-existing long-term conditions are
      associated with survival following acute myocardial infarction. The study will include an
      investigation of individual long term conditions for patients with acute myocardial
      infarction, including chronic heart failure, cerebrovascular disease, diabetes mellitus,
      chronic obstructive pulmonary disease, chronic renal failure or peripheral vascular disease
      as well as the combination of such conditions and their resulting impact on long term
      all-cause mortality (up to 8.4 years). In addition, an investigation of the association of
      receipt of guideline recommended care for acute myocardial infarction patients with
      pre-existing long term conditions will be made.
observational model: Cohort
time perspective: Prospective
measure: Number of patients who died from any cause by the end of the study censoring period
time frame: 8.4 years
description: Death data was obtained from national death records from the Office for National Statistics
measure: Number of patients who received guideline recommended therapy during the study period
time frame: Any guideline therapy administered during the patients hospital admission for acute myocardial infarction, an average of 4 days
description: All guideline recommended therapies for acute myocardial infarction relevant to the duration of the study period (2003 to 2013) will be assessed.
intervention type: Other
intervention name: long term conditions
description: Long term conditions including diabetes mellitus, chronic obstructive pulmonary disease or asthma, chronic heart failure, chronic renal failure, cerebrovascular disease or peripheral vascular disease.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Chris Gale, PhD, FRCP
role: Principal Investigator
affiliation: University of Leeds
url: https://medicinehealth.leeds.ac.uk/medicine/staff/390/dr-marlous-hall
description: Principal Researchers Profile Page
responsible party type: Sponsor-Investigator
investigator affiliation: University of Leeds
investigator full name: Marlous Hall
investigator title: Co-Investigator
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive
mesh term: Cerebrovascular Disorders
mesh term: Kidney Failure, Chronic
mesh term: Myocardial Infarction
mesh term: Vascular Diseases
mesh term: Peripheral Vascular Diseases
mesh term: Peripheral Arterial Disease
mesh term: Infarction
sharing ipd: No