<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/NCT03841487</url>
  </required_header>
  <id_info>
    <org_study_id>CMRPG3E1051</org_study_id>
    <nct_id>NCT03841487</nct_id>
  </id_info>
  <brief_title>Selective Aspiration Thrombectomy in STEMI</brief_title>
  <official_title>All-cause Mortality and the Risk of Stroke With Selective Aspiration Thrombectomy in Patients With ST-Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention - A Nationwide Retrospective Cohort Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chang Gung Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chang Gung Memorial Hospital</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>
      Patients who were diagnosed with ST-elevation myocardial infarction (STEMI) and received&#xD;
      primary percutaneous coronary intervention (PPCI) from July 2009 to December 2011 were&#xD;
      identified from the National Health Insurance Research Database of Taiwan. The investigators&#xD;
      compared the 1-year outcomes of patients with STEMI who received aspiration thrombectomy&#xD;
      during PPCI vs. those who received PPCI alone.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Data source and study population Using the National Health Insurance Research Database of&#xD;
      Taiwan, STEMI patients from July 2009 to December 2011 who received aspiration thrombectomy&#xD;
      during PPCI were defined as the thrombectomy group, and the remaining patients were defined&#xD;
      as the PCI alone group. ICD-9-CM codes were used to identify underlying comorbidities. Data&#xD;
      regarding the prescription of in-hospital and outpatient medications and the utilization of&#xD;
      medical devices were also extracted from the NHIRD using ICD-9-CM procedure codes and&#xD;
      pharmacology and device codes.&#xD;
&#xD;
      Study outcomes The primary endpoints of this study were all-cause mortality and stroke during&#xD;
      hospitalization and at 30 days and 1 year of follow-up. Ischemic and hemorrhagic subtypes of&#xD;
      stroke were further identified according to ICD-9-CM codes. All patientswere followed for 1&#xD;
      year or until the outcomes were achieved, whichever came first.&#xD;
&#xD;
      Statistical analysis Propensity score weighting was used to reduce potential differences&#xD;
      between the two study groups. The incidence rates of all-cause mortality and stroke were&#xD;
      estimated as the total number of events during the follow-up period divided by the&#xD;
      person-months at risk. For all-cause mortality, a Cox proportional hazard model was used to&#xD;
      obtain hazard ratios (HRs). For stroke, Fine and Gray's competing-risk regression was used to&#xD;
      obtain sub-hazard ratios (SHRs). The cumulative incidence of stroke versus follow-up time was&#xD;
      plotted rather than the event-free rate, because cumulative incidence function can take the&#xD;
      competing risk of death into account. For the thrombectomy group, 95% confidence intervals&#xD;
      (CIs) of the HRs and SHRs were calculated using the PCI alone group as the referent group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2018</start_date>
  <completion_date type="Actual">December 31, 2018</completion_date>
  <primary_completion_date type="Actual">December 31, 2018</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>Incidence rate of all-cause mortality at 30 days</measure>
    <time_frame>30 days from the date of primary percutaneous coronary intervention</time_frame>
    <description>The total number of death during the follow-up period divided by the person-months at risk</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence rate of stroke at 30 days</measure>
    <time_frame>30 days from the date of primary percutaneous coronary intervention</time_frame>
    <description>The total number of stroke events during the follow-up period divided by the person-months at risk</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence rate of all-cause mortality at 1 year</measure>
    <time_frame>1 year from the date of primary percutaneous coronary intervention</time_frame>
    <description>The total number of death during the follow-up period divided by the person-months at risk</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence rate of stroke at 1 year</measure>
    <time_frame>1 year from the date of primary percutaneous coronary intervention</time_frame>
    <description>The total number of stroke events during the follow-up period divided by the person-months at risk</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">9100</enrollment>
  <condition>ST Elevation Myocardial Infarction</condition>
  <arm_group>
    <arm_group_label>Aspiration thrombectomy</arm_group_label>
    <description>In the aspiration thrombectomy group, aspiration thrombectomy was performed for patients with ST elevation myocardial infarction who underwent primary percutaneous coronary intervention (PCI).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PCI alone</arm_group_label>
    <description>In the PCI alone group, the STEMI patient received conventional primary PCI without aspiration thrombectomy during the procedure.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Aspiration thrombectomy</intervention_name>
    <description>In the aspiration thrombectomy group, aspiration thrombectomy was performed for patients with ST elevation myocardial infarction who underwent primary percutaneous coronary intervention (PCI). In the PCI alone group, the STEMI patient received conventional primary PCI without aspiration thrombectomy during the procedure.</description>
    <arm_group_label>Aspiration thrombectomy</arm_group_label>
    <other_name>Percutaneous coronary intervention</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with ST elevation myocardial infarction who received primary percutaneous coronary&#xD;
        intervention&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with ST elevation myocardial infarction&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Missing data on sex or discharge date&#xD;
&#xD;
          -  Aged less than 18 years&#xD;
&#xD;
          -  Previous stroke&#xD;
&#xD;
          -  Patients receiving thrombolytic therapy&#xD;
&#xD;
          -  Patients who did not undergo PPCI&#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>Ying-Chang Tung</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chang Gung Memorial Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Linkou Chang Gung Memorial Hospital</name>
      <address>
        <city>Taoyuan</city>
        <zip>333</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>February 12, 2019</study_first_submitted>
  <study_first_submitted_qc>February 13, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <last_update_submitted>February 13, 2019</last_update_submitted>
  <last_update_submitted_qc>February 13, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chang Gung Memorial Hospital</investigator_affiliation>
    <investigator_full_name>Ying-Chang Tung</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>ST-elevation myocardial infarction</keyword>
  <keyword>Thrombectomy</keyword>
  <keyword>Mortality</keyword>
  <keyword>Stroke</keyword>
  <keyword>Physician volume</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myocardial Infarction</mesh_term>
    <mesh_term>ST Elevation Myocardial Infarction</mesh_term>
    <mesh_term>Infarction</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Individual participant data is encrypted and is not allowed to share based on the regulations of the National Health Insurance Research Database of Taiwan.</ipd_description>
  </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/NCT03841487
org study id: CMRPG3E1051
nct id: NCT03841487
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Patients who were diagnosed with ST-elevation myocardial infarction (STEMI) and received
      primary percutaneous coronary intervention (PPCI) from July 2009 to December 2011 were
      identified from the National Health Insurance Research Database of Taiwan. The investigators
      compared the 1-year outcomes of patients with STEMI who received aspiration thrombectomy
      during PPCI vs. those who received PPCI alone.
Data source and study population Using the National Health Insurance Research Database of
      Taiwan, STEMI patients from July 2009 to December 2011 who received aspiration thrombectomy
      during PPCI were defined as the thrombectomy group, and the remaining patients were defined
      as the PCI alone group. ICD-9-CM codes were used to identify underlying comorbidities. Data
      regarding the prescription of in-hospital and outpatient medications and the utilization of
      medical devices were also extracted from the NHIRD using ICD-9-CM procedure codes and
      pharmacology and device codes.

      Study outcomes The primary endpoints of this study were all-cause mortality and stroke during
      hospitalization and at 30 days and 1 year of follow-up. Ischemic and hemorrhagic subtypes of
      stroke were further identified according to ICD-9-CM codes. All patientswere followed for 1
      year or until the outcomes were achieved, whichever came first.

      Statistical analysis Propensity score weighting was used to reduce potential differences
      between the two study groups. The incidence rates of all-cause mortality and stroke were
      estimated as the total number of events during the follow-up period divided by the
      person-months at risk. For all-cause mortality, a Cox proportional hazard model was used to
      obtain hazard ratios (HRs). For stroke, Fine and Gray's competing-risk regression was used to
      obtain sub-hazard ratios (SHRs). The cumulative incidence of stroke versus follow-up time was
      plotted rather than the event-free rate, because cumulative incidence function can take the
      competing risk of death into account. For the thrombectomy group, 95% confidence intervals
      (CIs) of the HRs and SHRs were calculated using the PCI alone group as the referent group.
observational model: Cohort
time perspective: Retrospective
measure: Incidence rate of all-cause mortality at 30 days
time frame: 30 days from the date of primary percutaneous coronary intervention
description: The total number of death during the follow-up period divided by the person-months at risk
measure: Incidence rate of stroke at 30 days
time frame: 30 days from the date of primary percutaneous coronary intervention
description: The total number of stroke events during the follow-up period divided by the person-months at risk
measure: Incidence rate of all-cause mortality at 1 year
time frame: 1 year from the date of primary percutaneous coronary intervention
description: The total number of death during the follow-up period divided by the person-months at risk
measure: Incidence rate of stroke at 1 year
time frame: 1 year from the date of primary percutaneous coronary intervention
description: The total number of stroke events during the follow-up period divided by the person-months at risk
arm group label: Aspiration thrombectomy
description: In the aspiration thrombectomy group, aspiration thrombectomy was performed for patients with ST elevation myocardial infarction who underwent primary percutaneous coronary intervention (PCI).
arm group label: PCI alone
description: In the PCI alone group, the STEMI patient received conventional primary PCI without aspiration thrombectomy during the procedure.
intervention type: Device
intervention name: Aspiration thrombectomy
description: In the aspiration thrombectomy group, aspiration thrombectomy was performed for patients with ST elevation myocardial infarction who underwent primary percutaneous coronary intervention (PCI). In the PCI alone group, the STEMI patient received conventional primary PCI without aspiration thrombectomy during the procedure.
arm group label: Aspiration thrombectomy
other name: Percutaneous coronary intervention
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ying-Chang Tung
role: Principal Investigator
affiliation: Chang Gung Memorial Hospital
facility: 
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: Chang Gung Memorial Hospital
investigator full name: Ying-Chang Tung
investigator title: Principal Investigator
mesh term: Myocardial Infarction
mesh term: ST Elevation Myocardial Infarction
mesh term: Infarction
sharing ipd: No
ipd description: Individual participant data is encrypted and is not allowed to share based on the regulations of the National Health Insurance Research Database of Taiwan.