<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/NCT02261324</url>
  </required_header>
  <id_info>
    <org_study_id>2013LF001H</org_study_id>
    <nct_id>NCT02261324</nct_id>
  </id_info>
  <brief_title>Is the 4MGS a Useful Outcome Measure Post-PPCI</brief_title>
  <official_title>Is the Four Metre Gait Speed a Useful Outcome Measure in Patients With Acute Myocardial Infarction After Primary Percutaneous Coronary Intervention?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Royal Brompton &amp; Harefield NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Medical Research Council</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Royal Brompton &amp; Harefield NHS Foundation Trust</source>
  <brief_summary>
    <textblock>
      This study aims to assess usual walking speed (4-metre gait speed) in patients undergoing&#xD;
      primary percutaneous coronary intervention (PCI) for acute myocardial infarction and to&#xD;
      assess whether this can predict future cardiovascular events and death.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2013</start_date>
  <completion_date type="Actual">January 2021</completion_date>
  <primary_completion_date type="Actual">January 2017</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Mortality rate</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Occurrence of cardiovascular events</measure>
    <time_frame>1 and 5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Need for repeat revascularisation</measure>
    <time_frame>1 and 5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health resource usage</measure>
    <time_frame>1 and 5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>All-cause mortality</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiovascular death</measure>
    <time_frame>1 and 5 years</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">560</enrollment>
  <condition>Acute Myocardial Infarction</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Any patient hospitalised for primary percutaneous coronary intervention for acute&#xD;
        myocardial infarction. The cohort will be recruited from Harefield hospital&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Any patient hospitalised with an acute myocardial infarction who has undergone primary&#xD;
             percutaneous coronary intervention&#xD;
&#xD;
          -  Capacity to consent&#xD;
&#xD;
          -  Able to walk&#xD;
&#xD;
          -  Age over 18 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Significant co-morbidities that would limit exercise capacity or make exercise unsafe&#xD;
             (e.g. neuromuscular disease, severe hip/lower limb joint pain, peripheral vascular&#xD;
             disease, lower limb amputation)&#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>William DC Man, FRCP PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>NIHR Respiratory Biomedical Research Unit Royal Brompton &amp; Harefield NHS Foundation Trust</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Harefield Hospital</name>
      <address>
        <city>Harefield</city>
        <state>Middlesex</state>
        <zip>UB9 6JH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>May 1, 2014</study_first_submitted>
  <study_first_submitted_qc>October 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 10, 2014</study_first_posted>
  <last_update_submitted>March 10, 2021</last_update_submitted>
  <last_update_submitted_qc>March 10, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 12, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Percutaneous coronary intervention</keyword>
  <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>


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/NCT02261324
org study id: 2013LF001H
nct id: NCT02261324
lead sponsor: 
collaborator: 
This study aims to assess usual walking speed (4-metre gait speed) in patients undergoing
      primary percutaneous coronary intervention (PCI) for acute myocardial infarction and to
      assess whether this can predict future cardiovascular events and death.
observational model: Cohort
time perspective: Prospective
measure: Mortality rate
time frame: 1 year
measure: Occurrence of cardiovascular events
time frame: 1 and 5 years
measure: Need for repeat revascularisation
time frame: 1 and 5 years
measure: Health resource usage
time frame: 1 and 5 years
measure: All-cause mortality
time frame: 5 years
measure: Cardiovascular death
time frame: 1 and 5 years
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: William DC Man, FRCP PhD
role: Principal Investigator
affiliation: NIHR Respiratory Biomedical Research Unit Royal Brompton & Harefield NHS Foundation Trust
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Myocardial Infarction
mesh term: Infarction