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/NCT06040528</url>
    </required_header>
    <id_info>
      <org_study_id>AWAIT</org_study_id>
      <nct_id>NCT06040528</nct_id>
    </id_info>
    <brief_title>Early Discharge Pathway Registry</brief_title>
    <official_title>Barts Early Post-Acute Myocardial Infarction Discharge Registry</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Queen Mary University of London</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Queen Mary University of London</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>
        Despite the year-on-year decrease, coronary artery disease (CAD) still remains one of the&#xD;
        leading causes of mortality worldwide. With advances in technology and our understanding of&#xD;
        cardiac disease, we can now treat CAD using minimally invasive interventional techniques.&#xD;
        This has revolutionised treatment for and improved the lives of many patients with CAD.&#xD;
        Although trials have assessed various therapeutic strategies in various populations,&#xD;
        real-world evidence of intervention and medical treatment among patients with CAD is&#xD;
        increasingly recognised as an important part of providing safety and efficacy data and&#xD;
        improving the care we provide.&#xD;
  &#xD;
        Regional heart attack services have improved clinical outcomes following ST-segment elevation&#xD;
        myocardial infarction (STEMI) by facilitating early reperfusion by primary percutaneous&#xD;
        coronary intervention (PCI). Early discharge after primary PCI is welcomed by patients and&#xD;
        increases the efficiency of health care.&#xD;
  &#xD;
        This data will add to that literature by assessing the characteristics and outcomes of&#xD;
        patients with CAD, concentrating on those who are discharged via the early discharge pathway.&#xD;
        It will also identify and characterise predictors of outcomes, and improve risk&#xD;
        stratification and diagnostic evaluation.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The proposed study includes one of the largest coronary interventional programmes in the UK&#xD;
        at Europe's largest cardiac centre (BHC). This has allowed us to accumulate a large number of&#xD;
        patients in just over 4 years. All patients admitted with acute coronary syndrome and&#xD;
        discharged via the early discharge pathway are included in this study using a clinical&#xD;
        database. The database is password-protected and includes demographic, clinical and outcome&#xD;
        data.&#xD;
  &#xD;
        The database includes patients with simple to complex CAD. We will use this database to test&#xD;
        several hypotheses including but not limited to investigating characteristics of patients&#xD;
        treated, complications of interventional treatment and outcomes of patients. This research&#xD;
        will add substantially to the literature by providing real-world data from a leading coronary&#xD;
        centre.&#xD;
  &#xD;
        In this registry, we will assess the safety and feasibility of the EHD pathway for patients&#xD;
        who were discharged after primary PCI from a high-volume heart attack centre in London.&#xD;
  &#xD;
        The impact of this study will have local, regional and global consequences with an emphasis&#xD;
        on investigating poorly studied areas (e.g. decompensated aortic stenosis) and providing&#xD;
        evidence to improve their management and stimulate further research.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">January 1, 2021</start_date>
    <completion_date type="Anticipated">December 31, 2026</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2025</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>12 Months</target_duration>
    <primary_outcome>
      <measure>Assessment of Titration of medication</measure>
      <time_frame>1 year</time_frame>
      <description>To assess how medical therapy has been titrated in patients on the early discharge pathway</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Measurement of MACE</measure>
      <time_frame>1 year</time_frame>
      <description>Assessment of MACE events in patients on the early discharge pathway</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Assessment of Quality of Life</measure>
      <time_frame>1 year</time_frame>
      <description>Assess QoL using Questionnaire to assess change in symptoms at 1 year</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">20000</enrollment>
    <condition>Myocardial Infarction</condition>
    <condition>ST Elevation Myocardial Infarction</condition>
    <condition>Non-ST Elevation Myocardial Infarction</condition>
    <arm_group>
      <arm_group_label>Patients discharged on the Early Discharge Pathway at Barts Heart Centre</arm_group_label>
      <description>This study aims to assess, in a real-world setting, the safety, efficacy and feasibility of further investigations in patients with acute coronary syndrome who are admitted to Barts Heart Centre and are discharged via the early discharge pathway.</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          This study will include all patients admitted to or reviewed at Barts Heart Centre (St.&#xD;
          Bartholomew's Hospital) who are discharged via the early discharge pathway. These patients&#xD;
          range from young adults to the elderly and will include any patient ≥16 years of age.&#xD;
          Patients who are followed up with and without any intervention (i.e. both medically managed&#xD;
          patients as well as patients undergoing intervention) are equally as important and&#xD;
          therefore we shall include both groups of patients.&#xD;
  &#xD;
          Patients will be included from referrals made by other clinicians either as in or&#xD;
          outpatients. All these patients have their clinical data captured on a database or hospital&#xD;
          based clinical programme.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Informed consent will not be sought for, as patients are automatically included onto a&#xD;
          database that we will use for research purposes. No children will be included in this&#xD;
          study. Vulnerable adults or those unable to give consent will be included in the study as&#xD;
          well if they are referred to the Interventional Cardiology team.&#xD;
  &#xD;
          Both male and female patients ≥16 years of age will be included&#xD;
  &#xD;
          All patients will have been admitted to BHC with acute coronary syndrome.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Patients &lt;16 years will not be included in this study.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>16 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Dr. Daniel A Jones</last_name>
      <phone>02073777000</phone>
      <email>dan.jones8@nhs.net</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Dr. Krishnaraj S Rathod</last_name>
      <phone>02073777000</phone>
      <email>krishnaraj.rathod1@nhs.net</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Barts Health NHS Trust</name>
        <address>
          <city>London</city>
          <country>United Kingdom</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Dr. Daniel A Rathod</last_name>
        <phone>02073777000</phone>
        <email>dan.jones8@nhs.net</email>
      </contact>
      <contact_backup>
        <last_name>Dr. Krishnaraj S Rathod</last_name>
        <phone>02073777000</phone>
        <email>krishnaraj.rathod1@nhs.net</email>
      </contact_backup>
    </location>
    <location>
      <facility>
        <name>Dr. Daniel Jones</name>
        <address>
          <city>London</city>
          <country>United Kingdom</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Daniel A Jones</last_name>
        <phone>02073777000</phone>
        <email>dan.jones8@nhs.net</email>
      </contact>
      <contact_backup>
        <last_name>Krishnaraj S Rathod</last_name>
        <phone>02073777000</phone>
        <email>krishnaraj.rathod1@nhs.net</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>United Kingdom</country>
    </location_countries>
    <reference>
      <citation>Jones DA, Rathod KS, Howard JP, Gallagher S, Antoniou S, De Palma R, Guttmann O, Cliffe S, Colley J, Butler J, Ferguson E, Mohiddin S, Kapur A, Knight CJ, Jain AK, Rothman MT, Mathur A, Timmis AD, Smith EJ, Wragg A. Safety and feasibility of hospital discharge 2 days following primary percutaneous intervention for ST-segment elevation myocardial infarction. Heart. 2012 Dec;98(23):1722-7. doi: 10.1136/heartjnl-2012-302414. Epub 2012 Oct 10.</citation>
      <PMID>23053711</PMID>
    </reference>
    <reference>
      <citation>Jones DA, Rathod KS, Mathur A, Archbold RA. Discharge after primary percutaneous coronary intervention: the earlier the better? Eur Heart J Qual Care Clin Outcomes. 2022 May 5;8(3):229-231. doi: 10.1093/ehjqcco/qcab100. No abstract available.</citation>
      <PMID>34951919</PMID>
    </reference>
    <reference>
      <citation>Rathod KS, Comer K, Casey-Gillman O, Moore L, Mills G, Ferguson G, Antoniou S, Patel R, Fhadil S, Damani T, Wright P, Ozkor M, Das D, Guttmann OP, Baumbach A, Archbold RA, Wragg A, Jain AK, Choudry FA, Mathur A, Jones DA. Early Hospital Discharge Following PCI for Patients With STEMI. J Am Coll Cardiol. 2021 Dec 21;78(25):2550-2560. doi: 10.1016/j.jacc.2021.09.1379.</citation>
      <PMID>34915986</PMID>
    </reference>
    <verification_date>November 2022</verification_date>
    <study_first_submitted>December 22, 2022</study_first_submitted>
    <study_first_submitted_qc>September 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 15, 2023</study_first_posted>
    <last_update_submitted>September 8, 2023</last_update_submitted>
    <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 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>ST Elevation Myocardial Infarction</mesh_term>
      <mesh_term>Non-ST Elevated Myocardial Infarction</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>
  
  
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/NCT06040528
  org study id: AWAIT
  nct id: NCT06040528
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Despite the year-on-year decrease, coronary artery disease (CAD) still remains one of the
        leading causes of mortality worldwide. With advances in technology and our understanding of
        cardiac disease, we can now treat CAD using minimally invasive interventional techniques.
        This has revolutionised treatment for and improved the lives of many patients with CAD.
        Although trials have assessed various therapeutic strategies in various populations,
        real-world evidence of intervention and medical treatment among patients with CAD is
        increasingly recognised as an important part of providing safety and efficacy data and
        improving the care we provide.
  
        Regional heart attack services have improved clinical outcomes following ST-segment elevation
        myocardial infarction (STEMI) by facilitating early reperfusion by primary percutaneous
        coronary intervention (PCI). Early discharge after primary PCI is welcomed by patients and
        increases the efficiency of health care.
  
        This data will add to that literature by assessing the characteristics and outcomes of
        patients with CAD, concentrating on those who are discharged via the early discharge pathway.
        It will also identify and characterise predictors of outcomes, and improve risk
        stratification and diagnostic evaluation.
  The proposed study includes one of the largest coronary interventional programmes in the UK
        at Europe's largest cardiac centre (BHC). This has allowed us to accumulate a large number of
        patients in just over 4 years. All patients admitted with acute coronary syndrome and
        discharged via the early discharge pathway are included in this study using a clinical
        database. The database is password-protected and includes demographic, clinical and outcome
        data.
  
        The database includes patients with simple to complex CAD. We will use this database to test
        several hypotheses including but not limited to investigating characteristics of patients
        treated, complications of interventional treatment and outcomes of patients. This research
        will add substantially to the literature by providing real-world data from a leading coronary
        centre.
  
        In this registry, we will assess the safety and feasibility of the EHD pathway for patients
        who were discharged after primary PCI from a high-volume heart attack centre in London.
  
        The impact of this study will have local, regional and global consequences with an emphasis
        on investigating poorly studied areas (e.g. decompensated aortic stenosis) and providing
        evidence to improve their management and stimulate further research.
  observational model: Cohort
  time perspective: Prospective
  measure: Assessment of Titration of medication
  time frame: 1 year
  description: To assess how medical therapy has been titrated in patients on the early discharge pathway
  measure: Measurement of MACE
  time frame: 1 year
  description: Assessment of MACE events in patients on the early discharge pathway
  measure: Assessment of Quality of Life
  time frame: 1 year
  description: Assess QoL using Questionnaire to assess change in symptoms at 1 year
  arm group label: Patients discharged on the Early Discharge Pathway at Barts Heart Centre
  description: This study aims to assess, in a real-world setting, the safety, efficacy and feasibility of further investigations in patients with acute coronary syndrome who are admitted to Barts Heart Centre and are discharged via the early discharge pathway.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 16 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Dr. Daniel A Jones
  phone: 02073777000
  email: dan.jones8@nhs.net
  last name: Dr. Krishnaraj S Rathod
  phone: 02073777000
  email: krishnaraj.rathod1@nhs.net
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: United Kingdom
  citation: Jones DA, Rathod KS, Howard JP, Gallagher S, Antoniou S, De Palma R, Guttmann O, Cliffe S, Colley J, Butler J, Ferguson E, Mohiddin S, Kapur A, Knight CJ, Jain AK, Rothman MT, Mathur A, Timmis AD, Smith EJ, Wragg A. Safety and feasibility of hospital discharge 2 days following primary percutaneous intervention for ST-segment elevation myocardial infarction. Heart. 2012 Dec;98(23):1722-7. doi: 10.1136/heartjnl-2012-302414. Epub 2012 Oct 10.
  PMID: 23053711
  citation: Jones DA, Rathod KS, Mathur A, Archbold RA. Discharge after primary percutaneous coronary intervention: the earlier the better? Eur Heart J Qual Care Clin Outcomes. 2022 May 5;8(3):229-231. doi: 10.1093/ehjqcco/qcab100. No abstract available.
  PMID: 34951919
  citation: Rathod KS, Comer K, Casey-Gillman O, Moore L, Mills G, Ferguson G, Antoniou S, Patel R, Fhadil S, Damani T, Wright P, Ozkor M, Das D, Guttmann OP, Baumbach A, Archbold RA, Wragg A, Jain AK, Choudry FA, Mathur A, Jones DA. Early Hospital Discharge Following PCI for Patients With STEMI. J Am Coll Cardiol. 2021 Dec 21;78(25):2550-2560. doi: 10.1016/j.jacc.2021.09.1379.
  PMID: 34915986
  responsible party type: Sponsor
  mesh term: Myocardial Infarction
  mesh term: ST Elevation Myocardial Infarction
  mesh term: Non-ST Elevated Myocardial Infarction
  mesh term: Infarction
  sharing ipd: No