xml: <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/NCT05974397</url>
    </required_header>
    <id_info>
      <org_study_id>CLCZ696BTW05</org_study_id>
      <nct_id>NCT05974397</nct_id>
    </id_info>
    <brief_title>Nationwide Trends in Incidence, Healthcare Utilization, and Mortality in Hospitalized Acute Myocardial Infarction Patients in Taiwan</brief_title>
    <official_title>Nationwide Trends in Incidence, Healthcare Utilization, and Mortality in Hospitalized Acute Myocardial Infarction Patients in Taiwan</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Novartis Pharmaceuticals</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Novartis</source>
    <brief_summary>
      <textblock>
        This was a retrospective study using the Taiwan's National Health Insurance Research Database&#xD;
        (NHIRD). The study employed two study designs for different purposes as follows:&#xD;
  &#xD;
          -  A cross-sectional analysis was conducted to explore the annual incidence trends.&#xD;
  &#xD;
          -  A longitudinal cohort study was conducted to assess baseline characteristics, treatment&#xD;
             patterns, long-term healthcare utilization, and cause-specific mortality among incident&#xD;
             AMI patients.&#xD;
  &#xD;
        In each part, the study was conducted for AMI, and separately for ST-segment elevation and&#xD;
        non-ST- segment elevation myocardial infarction (STEMI and NSTEMI)&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">September 30, 2021</start_date>
    <completion_date type="Actual">July 22, 2022</completion_date>
    <primary_completion_date type="Actual">July 22, 2022</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>Mean age of patients</measure>
      <time_frame>12 months</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of male patients</measure>
      <time_frame>12 months</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Year of patient entry into cohort</measure>
      <time_frame>12 months</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of patients with AMI in Taiwan</measure>
      <time_frame>12 months</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of patients with STEMI in Taiwan</measure>
      <time_frame>12 months</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of patients with NSTEMI in Taiwan</measure>
      <time_frame>12 months</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of AMI patients with comorbidities</measure>
      <time_frame>Up to 3 years</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of patients with treatment for AMI</measure>
      <time_frame>Up to 3 years</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of STEMI patients with comorbidities</measure>
      <time_frame>Up to 3 years</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of patients with treatment for STEMI</measure>
      <time_frame>Up to 3 years</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of NSTEMI patients with comorbidities</measure>
      <time_frame>Up to 3 years</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of patients with treatment for NSTEMI</measure>
      <time_frame>Up to 3 years</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of mortalities among AMI patients</measure>
      <time_frame>Up to 3 years</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of mortalities among STEMI patients</measure>
      <time_frame>Up to 3 years</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of mortalities among NSTEMI patients</measure>
      <time_frame>Up to 3 years</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of AMI patients with outpatient visits</measure>
      <time_frame>Up to 3 years</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of AMI patients with emergency room visits</measure>
      <time_frame>Up to 3 years</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of AMI patients with hospitalizations</measure>
      <time_frame>Up to 3 years</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Length of hospital stay for AMI patients</measure>
      <time_frame>Up to 3 years</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Direct medical costs for AMI patients</measure>
      <time_frame>Up to 3 years</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of STEMI patients with outpatient visits</measure>
      <time_frame>Up to 3 years</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of STEMI patients with emergency room visits</measure>
      <time_frame>Up to 3 years</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of STEMI patients with hospitalizations</measure>
      <time_frame>Up to 3 years</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Length of hospital stay for STEMI patients</measure>
      <time_frame>Up to 3 years</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Direct medical costs for STEMI patients</measure>
      <time_frame>Up to 3 years</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of NSTEMI patients with outpatient visits</measure>
      <time_frame>Up to 3 years</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of NSTEMI patients with emergency room visits</measure>
      <time_frame>Up to 3 years</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of NSTEMI patients with hospitalizations</measure>
      <time_frame>Up to 3 years</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Length of hospital stay for NSTEMI patients</measure>
      <time_frame>Up to 3 years</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Direct medical costs for NSTEMI patients</measure>
      <time_frame>Up to 3 years</time_frame>
    </primary_outcome>
    <number_of_groups>3</number_of_groups>
    <enrollment type="Actual">124018</enrollment>
    <condition>Acute Myocardial Infarction</condition>
    <arm_group>
      <arm_group_label>AMI</arm_group_label>
      <description>Patients with AMI</description>
    </arm_group>
    <arm_group>
      <arm_group_label>STEMI</arm_group_label>
      <description>Patients with STEMI</description>
    </arm_group>
    <arm_group>
      <arm_group_label>NSTEMI</arm_group_label>
      <description>Patients with NSTEMI</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          This was a retrospective, noninterventional cohort study.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Cross-sectional analysis:&#xD;
  &#xD;
            -  Patients aged 20 years and older.&#xD;
  &#xD;
            -  Patients who had been admitted for AMI, defined as primary or first secondary&#xD;
               diagnosis of AMI between 2014 and 2020.&#xD;
  &#xD;
            -  The diagnosis of AMI/ STEMI/ NSTEMI was identified by the International Classification&#xD;
               of Diseases, 9th Revision, Clinical Modification (ICD-9-CM) codes and 10th revision&#xD;
               (ICD-10-CM) codes.&#xD;
  &#xD;
            -  Incident cases of AMI hospitalization were defined as no history of AMI-related&#xD;
               hospitalization or outpatient visit within 1 year before admission.&#xD;
  &#xD;
          Longitudinal analysis:&#xD;
  &#xD;
          Patients aged 20 years and older.&#xD;
  &#xD;
            -  Patients who had been admitted for AMI, defined as primary or first secondary&#xD;
               diagnosis of AMI between 2014 and 2017.&#xD;
  &#xD;
            -  The diagnosis of AMI/ STEMI/ NSTEMI was identified by ICD-9-CM codes and ICD-10-CM&#xD;
               codes. (The ICD-9-CM code and ICD-10-CM codes were the same as above)&#xD;
  &#xD;
            -  Incident cases of AMI hospitalization were defined as no history of AMI-related&#xD;
               hospitalization or outpatient visit within 1 year before admission.&#xD;
  &#xD;
            -  The cohort entry date was defined as the admission date of incident AMI&#xD;
               hospitalization, and the index date was defined as the discharge date of incident&#xD;
               hospitalization.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          None specified&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Novartis Pharmaceuticals</last_name>
      <role>Study Director</role>
      <affiliation>Novartis Pharmaceuticals</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Novartis</name>
        <address>
          <city>Taipei</city>
          <country>Taiwan</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Taiwan</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 20, 2023</study_first_submitted>
    <study_first_submitted_qc>August 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 3, 2023</study_first_posted>
    <last_update_submitted>August 1, 2023</last_update_submitted>
    <last_update_submitted_qc>August 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 3, 2023</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>Myocardial Infarction</mesh_term>
      <mesh_term>Infarction</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05974397
  org study id: CLCZ696BTW05
  nct id: NCT05974397
  lead sponsor: 
  This was a retrospective study using the Taiwan's National Health Insurance Research Database
        (NHIRD). The study employed two study designs for different purposes as follows:
  
          -  A cross-sectional analysis was conducted to explore the annual incidence trends.
  
          -  A longitudinal cohort study was conducted to assess baseline characteristics, treatment
             patterns, long-term healthcare utilization, and cause-specific mortality among incident
             AMI patients.
  
        In each part, the study was conducted for AMI, and separately for ST-segment elevation and
        non-ST- segment elevation myocardial infarction (STEMI and NSTEMI)
  observational model: Cohort
  time perspective: Retrospective
  measure: Mean age of patients
  time frame: 12 months
  measure: Number of male patients
  time frame: 12 months
  measure: Year of patient entry into cohort
  time frame: 12 months
  measure: Number of patients with AMI in Taiwan
  time frame: 12 months
  measure: Number of patients with STEMI in Taiwan
  time frame: 12 months
  measure: Number of patients with NSTEMI in Taiwan
  time frame: 12 months
  measure: Number of AMI patients with comorbidities
  time frame: Up to 3 years
  measure: Number of patients with treatment for AMI
  time frame: Up to 3 years
  measure: Number of STEMI patients with comorbidities
  time frame: Up to 3 years
  measure: Number of patients with treatment for STEMI
  time frame: Up to 3 years
  measure: Number of NSTEMI patients with comorbidities
  time frame: Up to 3 years
  measure: Number of patients with treatment for NSTEMI
  time frame: Up to 3 years
  measure: Number of mortalities among AMI patients
  time frame: Up to 3 years
  measure: Number of mortalities among STEMI patients
  time frame: Up to 3 years
  measure: Number of mortalities among NSTEMI patients
  time frame: Up to 3 years
  measure: Number of AMI patients with outpatient visits
  time frame: Up to 3 years
  measure: Number of AMI patients with emergency room visits
  time frame: Up to 3 years
  measure: Number of AMI patients with hospitalizations
  time frame: Up to 3 years
  measure: Length of hospital stay for AMI patients
  time frame: Up to 3 years
  measure: Direct medical costs for AMI patients
  time frame: Up to 3 years
  measure: Number of STEMI patients with outpatient visits
  time frame: Up to 3 years
  measure: Number of STEMI patients with emergency room visits
  time frame: Up to 3 years
  measure: Number of STEMI patients with hospitalizations
  time frame: Up to 3 years
  measure: Length of hospital stay for STEMI patients
  time frame: Up to 3 years
  measure: Direct medical costs for STEMI patients
  time frame: Up to 3 years
  measure: Number of NSTEMI patients with outpatient visits
  time frame: Up to 3 years
  measure: Number of NSTEMI patients with emergency room visits
  time frame: Up to 3 years
  measure: Number of NSTEMI patients with hospitalizations
  time frame: Up to 3 years
  measure: Length of hospital stay for NSTEMI patients
  time frame: Up to 3 years
  measure: Direct medical costs for NSTEMI patients
  time frame: Up to 3 years
  arm group label: AMI
  description: Patients with AMI
  arm group label: STEMI
  description: Patients with STEMI
  arm group label: NSTEMI
  description: Patients with NSTEMI
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Novartis Pharmaceuticals
  role: Study Director
  affiliation: Novartis Pharmaceuticals
  facility: 
  country: Taiwan
  responsible party type: Sponsor
  mesh term: Myocardial Infarction
  mesh term: Infarction