<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/NCT02184949</url>
  </required_header>
  <id_info>
    <org_study_id>NICOR-PCI-VolOut</org_study_id>
    <nct_id>NCT02184949</nct_id>
  </id_info>
  <brief_title>Exploring the Volume-Outcome Relationship for PCI Procedures Undertaken in a UK Context: A NICOR Study</brief_title>
  <official_title>Percutaneous Coronary Interventions in the UK: The Relationship Between Procedural Volumes and Patient Outcomes in a Changing Context (A NICOR Study)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University College, London</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute for Cardiovascular Outcomes Research</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>British Cardiovascular Society</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>British Cardiovascular Intervention Society</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University College, London</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The relationship between annual procedural volume and patient outcome remains a debated issue&#xD;
      in the field of interventional medicine. An under-explored issue in a UK context is whether&#xD;
      or not such a relationship exists for percutaneous coronary interventions (PCI). In recent&#xD;
      years, this procedure has replaced thrombolysis as the standard intervention method used in&#xD;
      UK hospitals for widening patients' obstructed coronary arteries. However, the actual number&#xD;
      of such procedures currently undertaken annually remains variable across hospitals where&#xD;
      these interventions are performed. The UK's National Institute for Health and Care Excellence&#xD;
      has consequently called for research into whether such differences in volume play any role in&#xD;
      patient outcome for this particular procedure. The current study is intended to address that&#xD;
      research need, and will do so by looking at whether the annual number of PCI procedures&#xD;
      undertaken by individual hospitals is predictive of patient mortality post-procedure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Using data collected as part of a UK national audit of percutaneous coronary interventions,&#xD;
      this study will:&#xD;
&#xD;
        -  Establish whether annual hospital volume is a clinically important novel risk factor for&#xD;
           30-day mortality post-PCI when examined relative to a newly developed risk model&#xD;
           intended for use in clinical practice.&#xD;
&#xD;
        -  Establish whether the nature of this volume-outcome relationship is best fit as a linear&#xD;
           or non-linear model.&#xD;
&#xD;
        -  Establish whether annual hospital volume is a clinically important novel risk factor for&#xD;
           30-day mortality post-primary PCI when examined relative to a newly developed risk model&#xD;
           intended for use in clinical practice.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2014</start_date>
  <completion_date type="Actual">April 2015</completion_date>
  <primary_completion_date type="Actual">December 2014</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>30 days post-procedure</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">427467</enrollment>
  <condition>Percutaneous Coronary Intervention</condition>
  <arm_group>
    <arm_group_label>Primary Sample</arm_group_label>
    <description>All percutaneous coronary intervention patients who meet the primary eligibility criteria for this study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Subsample</arm_group_label>
    <description>Patients drawn from the main sample who specifically underwent a primary percutaneous coronary intervention procedure.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Percutaneous Coronary Intervention</intervention_name>
    <arm_group_label>Primary Sample</arm_group_label>
    <other_name>PCI</other_name>
    <other_name>Coronary angioplasty</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Primary Percutaneous Coronary Intervention</intervention_name>
    <arm_group_label>Subsample</arm_group_label>
    <other_name>pPCI</other_name>
    <other_name>Primary angioplasty</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Percutaneous coronary interventions undertaken in UK hospitals are recorded in the UK&#xD;
        National Audit of Percutaneous Coronary Intervention. Patients who contribute data to this&#xD;
        audit will be eligible for inclusion in this study. Additional inclusion criteria, as&#xD;
        described below, will be applied to ensure that data are appropriate for the intended&#xD;
        analysis.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  are aged between 18 and 100 (inclusive) on the date of their procedure;&#xD;
&#xD;
          -  do not have pre-operative ventilation;&#xD;
&#xD;
          -  undergo a PCI procedure in a UK hospital that contributes data to the National Audit&#xD;
             of Percutaneous Coronary Intervention; and&#xD;
&#xD;
          -  have a tracked mortality status at 30 days' post-procedure.&#xD;
&#xD;
        To account for potential dependencies in the data, patients' non-index (i.e. follow-up) PCI&#xD;
        procedures occurring during the data collection period will be excluded from the study&#xD;
        sample.&#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>D O'Neill, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University College, London</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University College London</name>
      <address>
        <city>London</city>
        <zip>WC1E 6BT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>July 3, 2014</study_first_submitted>
  <study_first_submitted_qc>July 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 9, 2014</study_first_posted>
  <last_update_submitted>May 1, 2018</last_update_submitted>
  <last_update_submitted_qc>May 1, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 4, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University College, London</investigator_affiliation>
    <investigator_full_name>Dara O'Neill</investigator_full_name>
    <investigator_title>Information Analyst</investigator_title>
  </responsible_party>
  <keyword>PCI</keyword>
  <keyword>Coronary angioplasty</keyword>
  <keyword>Percutaneous transluminal coronary angioplasty</keyword>
  <keyword>PTCA</keyword>
  <!-- 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/NCT02184949
org study id: NICOR-PCI-VolOut
nct id: NCT02184949
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
The relationship between annual procedural volume and patient outcome remains a debated issue
      in the field of interventional medicine. An under-explored issue in a UK context is whether
      or not such a relationship exists for percutaneous coronary interventions (PCI). In recent
      years, this procedure has replaced thrombolysis as the standard intervention method used in
      UK hospitals for widening patients' obstructed coronary arteries. However, the actual number
      of such procedures currently undertaken annually remains variable across hospitals where
      these interventions are performed. The UK's National Institute for Health and Care Excellence
      has consequently called for research into whether such differences in volume play any role in
      patient outcome for this particular procedure. The current study is intended to address that
      research need, and will do so by looking at whether the annual number of PCI procedures
      undertaken by individual hospitals is predictive of patient mortality post-procedure.
Using data collected as part of a UK national audit of percutaneous coronary interventions,
      this study will:

        -  Establish whether annual hospital volume is a clinically important novel risk factor for
           30-day mortality post-PCI when examined relative to a newly developed risk model
           intended for use in clinical practice.

        -  Establish whether the nature of this volume-outcome relationship is best fit as a linear
           or non-linear model.

        -  Establish whether annual hospital volume is a clinically important novel risk factor for
           30-day mortality post-primary PCI when examined relative to a newly developed risk model
           intended for use in clinical practice.
observational model: Cohort
time perspective: Retrospective
measure: All-cause mortality
time frame: 30 days post-procedure
arm group label: Primary Sample
description: All percutaneous coronary intervention patients who meet the primary eligibility criteria for this study.
arm group label: Subsample
description: Patients drawn from the main sample who specifically underwent a primary percutaneous coronary intervention procedure.
intervention type: Procedure
intervention name: Percutaneous Coronary Intervention
arm group label: Primary Sample
other name: PCI
other name: Coronary angioplasty
intervention type: Procedure
intervention name: Primary Percutaneous Coronary Intervention
arm group label: Subsample
other name: pPCI
other name: Primary angioplasty
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: D O'Neill, PhD
role: Principal Investigator
affiliation: University College, London
facility: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: University College, London
investigator full name: Dara O'Neill
investigator title: Information Analyst