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/NCT06033014</url>
    </required_header>
    <id_info>
      <org_study_id>p-2023-14244</org_study_id>
      <nct_id>NCT06033014</nct_id>
    </id_info>
    <brief_title>Clinical Implementation of a Novel Decision Support Tool in Patients With Ischemic Heart Disease</brief_title>
    <acronym>PM Heart</acronym>
    <official_title>Clinical Implementation of a Novel Decision Support Tool in Patients With Ischemic Heart Disease</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Rigshospitalet, Denmark</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Region Capital Denmark</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Region Zealand</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Rigshospitalet, Denmark</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>
        The PM-Heart algorithm (PMHeartIHD) is an in-house developed software that predict the&#xD;
        survival prognosis for the individual patient hospitalized with ischemic heart disease (IHD)&#xD;
        after a coronary arteriography has been performed. The software is intended to be used as a&#xD;
        clinical decision support system i.e. the calculated survival prognosis is expected to&#xD;
        enhance the quality of the treating physician's therapeutic considerations concerning (minor)&#xD;
        adjustments to the patients treatment and follow-up - all within the framework of the current&#xD;
        medical guidelines. Thus, the algorithm does not &quot;show the physician specifically what to&#xD;
        do&quot;, but rather ensures a better knowledgebase for the overall interpretation and choice of&#xD;
        management of the patient.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        To investigate the clinical usefulness of the developed clinical decision support system -&#xD;
        the PMHeartIHD algorithm - we wish to investigate whether the clinical use of the algorithm&#xD;
        will;&#xD;
  &#xD;
          -  Improve patient prognosis and,&#xD;
  &#xD;
          -  Minimize the risk of re-hospitalization,&#xD;
  &#xD;
        compared to patients who are treated without the attending/treating physician knowing the&#xD;
        algorithm's prognosis?&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">December 2026</completion_date>
    <primary_completion_date type="Anticipated">December 2026</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Other</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Number and duration of readmissions within one month after randomization</measure>
      <time_frame>From randomization to the study and up to 1 year hereafter</time_frame>
      <description>A composite outcome of a) readmissions within one month, and 2) all-cause mortality within one year - for patients randomized to the study.&#xD;
  All the outcomes listed below will be assessed as a comparison between the &quot;intervention group&quot; and the &quot;control group&quot;.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number and cause of death (all-cause mortality) within one year after randomization</measure>
      <time_frame>From randomization to the study and up to 1 year hereafter</time_frame>
      <description>A composite outcome of a) readmissions within one month, and 2) all-cause mortality within one year - for patients randomized to the study.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Readmission(s) within 30 days of the randomization</measure>
      <time_frame>Up to 30 days after randomization to the study.</time_frame>
      <description>Readmission(s) within 30 days of the randomization. Incl. information on the quantity, duration, cause, outcome etc.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cardiovascular readmission(s) within 30 days of the randomization</measure>
      <time_frame>Up to 30 days after randomization to the study.</time_frame>
      <description>Cardiovascular readmission(s) within 30 days of the randomization. Incl. information on the quantity, duration, cause, outcome etc.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Readmission(s) with acute coronary syndrome</measure>
      <time_frame>From randomization to the study and up to 1 year hereafter</time_frame>
      <description>Readmission(s) with acute coronary syndrome. Incl. information on the quantity, duration, cause, outcome etc.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>One-year survival</measure>
      <time_frame>From randomization to the study and up to 1 year hereafter</time_frame>
      <description>One-year survival</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Total number of days the primary hospitalization lasts</measure>
      <time_frame>From randomization to the study and up to 1 year hereafter</time_frame>
      <description>Length (i.e. total number of days) of the primary hospitalization (i.e. when the patient is randomized to the study).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Total number of days at the hospital incl. hospitalizations during the first year after inclusion</measure>
      <time_frame>From randomization to the study and up to 1 year hereafter</time_frame>
      <description>Total number of days in hospital during the first year after inclusion</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of hospitalizations the first year</measure>
      <time_frame>From randomization to the study and up to 1 year hereafter</time_frame>
      <description>Number of hospitalizations the first year</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number and type of performed cardiac investigations</measure>
      <time_frame>From randomization to the study and up to 1 year hereafter</time_frame>
      <description>Number and type of performed cardiac investigations; i.e. TTE, KAG, Heart-CT, Holter/R-tests, ECG, blood samples, etc.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of cardiac follow-up consultations at the hospital</measure>
      <time_frame>From randomization to the study and up to 1 year hereafter</time_frame>
      <description>Number of cardiac follow-up consultations at the hospital</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of check-ups for cardiovascular reasons at the general practitioner</measure>
      <time_frame>From randomization to the study and up to 1 year hereafter</time_frame>
      <description>Number of check-ups for cardiovascular reasons at the general practitioner.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of cardiovascular drugs at discharge</measure>
      <time_frame>From randomization to the study and up to 1 year hereafter</time_frame>
      <description>Number of cardiovascular drugs at discharge + after 1 year.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Dosages (DDD) of drugs at discharge</measure>
      <time_frame>Up to 1 year after randomization to study.</time_frame>
      <description>Dosages (DDD) of drugs at discharge + after 1 year.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of a) new ischemic events, b) arrhythmias, c) and/or heart failure</measure>
      <time_frame>Up to 1 year after randomization to study.</time_frame>
      <description>Incidence of a) new ischemic events, b) arrhythmias, c) and/or heart failure</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Health economic analyses of implementing the algorithm</measure>
      <time_frame>Up to 1 year after randomization to study.</time_frame>
      <description>Health economic analyses: How does implementing the algorithm alter the overall costs and resource spending, incl. e.g. social benefits, compared with standard-of-care.&#xD;
  i.e. does knowing a more precise 1-year mortality prediction reduce/increase the resource consumption.&#xD;
  Will be based on economic analyses of the costs related to the abovementioned outcome measurements.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The algorithm's reception and introduction in clinical use</measure>
      <time_frame>Before start of clinical study and up to 1 year after randomization to study.</time_frame>
      <description>We wish to investigate how the algorithm is introduced and received in the clinic, both by the medical staff but also the patients.&#xD;
  Will be investigated using interviews.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The usability of the algorithm</measure>
      <time_frame>Before start of clinical study and up to 1 year after randomization to study.</time_frame>
      <description>The usability of the algorithm i.e. is it easy to use/understand, any praise or criticisms, ideas for new features etc.&#xD;
  Will be based on questionaires and feedback from users.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>How, and to what extend, is the algorithm used by the medical staff.</measure>
      <time_frame>Before start of clinical study and up to 1 year after randomization to study.</time_frame>
      <description>We wish to investigate how, and to what extend, the algorithm is used by the medical staff, e.g. are the medical staff inclined to use the prediction, does it alter their treatment choices etc.&#xD;
  Will be based on questionaires, interviews, feedback from users, and assessment of &quot;look-ups&quot;.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">8000</enrollment>
    <condition>Ischemic Heart Disease</condition>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>The one-year mortality prediction, calculated by the PM Heart algorithm, will not be available to the physician.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Intervention</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The one-year mortality prediction, calculated by the PM Heart algorithm, will be available to the physician.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>PM HeartIHD prediction</intervention_name>
      <description>The calculated prediction and the explainability factors will be made available to the physician, which the physician then can decide to take into his/hers evaluation about further treatment.</description>
      <arm_group_label>Intervention</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Hospitalized patients in one of the involved departments of cardiology (see below)&#xD;
               with;&#xD;
  &#xD;
            -  Ischemic heart disease; the clinical presentation may be stable, worsening/unstable&#xD;
               angina, non-ST-elevation myocardial infarction or ST-elevation myocardial infarction,&#xD;
               and with - Significant coronary artery lesions or diffuse coronary artery disease on&#xD;
               invasive coronary angiography during the admission&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  &lt;18 years of age&#xD;
  &#xD;
            -  Living outside Denmark&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 18, 2023</study_first_submitted>
    <study_first_submitted_qc>September 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 4, 2023</last_update_submitted>
    <last_update_submitted_qc>September 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Rigshospitalet, Denmark</investigator_affiliation>
      <investigator_full_name>Henning Bundgaard</investigator_full_name>
      <investigator_title>Professor of Cardiology, Consultant, MD, DMSc</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Heart Diseases</mesh_term>
      <mesh_term>Myocardial Ischemia</mesh_term>
      <mesh_term>Coronary Artery Disease</mesh_term>
      <mesh_term>Ischemia</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/NCT06033014
  org study id: p-2023-14244
  nct id: NCT06033014
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The PM-Heart algorithm (PMHeartIHD) is an in-house developed software that predict the
        survival prognosis for the individual patient hospitalized with ischemic heart disease (IHD)
        after a coronary arteriography has been performed. The software is intended to be used as a
        clinical decision support system i.e. the calculated survival prognosis is expected to
        enhance the quality of the treating physician's therapeutic considerations concerning (minor)
        adjustments to the patients treatment and follow-up - all within the framework of the current
        medical guidelines. Thus, the algorithm does not "show the physician specifically what to
        do", but rather ensures a better knowledgebase for the overall interpretation and choice of
        management of the patient.
  To investigate the clinical usefulness of the developed clinical decision support system -
        the PMHeartIHD algorithm - we wish to investigate whether the clinical use of the algorithm
        will;
  
          -  Improve patient prognosis and,
  
          -  Minimize the risk of re-hospitalization,
  
        compared to patients who are treated without the attending/treating physician knowing the
        algorithm's prognosis?
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Other
  masking: None (Open Label)
  measure: Number and duration of readmissions within one month after randomization
  time frame: From randomization to the study and up to 1 year hereafter
  description: A composite outcome of a) readmissions within one month, and 2) all-cause mortality within one year - for patients randomized to the study.
  All the outcomes listed below will be assessed as a comparison between the "intervention group" and the "control group".
  measure: Number and cause of death (all-cause mortality) within one year after randomization
  time frame: From randomization to the study and up to 1 year hereafter
  description: A composite outcome of a) readmissions within one month, and 2) all-cause mortality within one year - for patients randomized to the study.
  measure: Readmission(s) within 30 days of the randomization
  time frame: Up to 30 days after randomization to the study.
  description: Readmission(s) within 30 days of the randomization. Incl. information on the quantity, duration, cause, outcome etc.
  measure: Cardiovascular readmission(s) within 30 days of the randomization
  time frame: Up to 30 days after randomization to the study.
  description: Cardiovascular readmission(s) within 30 days of the randomization. Incl. information on the quantity, duration, cause, outcome etc.
  measure: Readmission(s) with acute coronary syndrome
  time frame: From randomization to the study and up to 1 year hereafter
  description: Readmission(s) with acute coronary syndrome. Incl. information on the quantity, duration, cause, outcome etc.
  measure: One-year survival
  time frame: From randomization to the study and up to 1 year hereafter
  description: One-year survival
  measure: Total number of days the primary hospitalization lasts
  time frame: From randomization to the study and up to 1 year hereafter
  description: Length (i.e. total number of days) of the primary hospitalization (i.e. when the patient is randomized to the study).
  measure: Total number of days at the hospital incl. hospitalizations during the first year after inclusion
  time frame: From randomization to the study and up to 1 year hereafter
  description: Total number of days in hospital during the first year after inclusion
  measure: Number of hospitalizations the first year
  time frame: From randomization to the study and up to 1 year hereafter
  description: Number of hospitalizations the first year
  measure: Number and type of performed cardiac investigations
  time frame: From randomization to the study and up to 1 year hereafter
  description: Number and type of performed cardiac investigations; i.e. TTE, KAG, Heart-CT, Holter/R-tests, ECG, blood samples, etc.
  measure: Number of cardiac follow-up consultations at the hospital
  time frame: From randomization to the study and up to 1 year hereafter
  description: Number of cardiac follow-up consultations at the hospital
  measure: Number of check-ups for cardiovascular reasons at the general practitioner
  time frame: From randomization to the study and up to 1 year hereafter
  description: Number of check-ups for cardiovascular reasons at the general practitioner.
  measure: Number of cardiovascular drugs at discharge
  time frame: From randomization to the study and up to 1 year hereafter
  description: Number of cardiovascular drugs at discharge + after 1 year.
  measure: Dosages (DDD) of drugs at discharge
  time frame: Up to 1 year after randomization to study.
  description: Dosages (DDD) of drugs at discharge + after 1 year.
  measure: Incidence of a) new ischemic events, b) arrhythmias, c) and/or heart failure
  time frame: Up to 1 year after randomization to study.
  description: Incidence of a) new ischemic events, b) arrhythmias, c) and/or heart failure
  measure: Health economic analyses of implementing the algorithm
  time frame: Up to 1 year after randomization to study.
  description: Health economic analyses: How does implementing the algorithm alter the overall costs and resource spending, incl. e.g. social benefits, compared with standard-of-care.
  i.e. does knowing a more precise 1-year mortality prediction reduce/increase the resource consumption.
  Will be based on economic analyses of the costs related to the abovementioned outcome measurements.
  measure: The algorithm's reception and introduction in clinical use
  time frame: Before start of clinical study and up to 1 year after randomization to study.
  description: We wish to investigate how the algorithm is introduced and received in the clinic, both by the medical staff but also the patients.
  Will be investigated using interviews.
  measure: The usability of the algorithm
  time frame: Before start of clinical study and up to 1 year after randomization to study.
  description: The usability of the algorithm i.e. is it easy to use/understand, any praise or criticisms, ideas for new features etc.
  Will be based on questionaires and feedback from users.
  measure: How, and to what extend, is the algorithm used by the medical staff.
  time frame: Before start of clinical study and up to 1 year after randomization to study.
  description: We wish to investigate how, and to what extend, the algorithm is used by the medical staff, e.g. are the medical staff inclined to use the prediction, does it alter their treatment choices etc.
  Will be based on questionaires, interviews, feedback from users, and assessment of "look-ups".
  arm group label: Control
  arm group type: No Intervention
  description: The one-year mortality prediction, calculated by the PM Heart algorithm, will not be available to the physician.
  arm group label: Intervention
  arm group type: Experimental
  description: The one-year mortality prediction, calculated by the PM Heart algorithm, will be available to the physician.
  intervention type: Other
  intervention name: PM HeartIHD prediction
  description: The calculated prediction and the explainability factors will be made available to the physician, which the physician then can decide to take into his/hers evaluation about further treatment.
  arm group label: Intervention
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  responsible party type: Principal Investigator
  investigator affiliation: Rigshospitalet, Denmark
  investigator full name: Henning Bundgaard
  investigator title: Professor of Cardiology, Consultant, MD, DMSc
  mesh term: Heart Diseases
  mesh term: Myocardial Ischemia
  mesh term: Coronary Artery Disease
  mesh term: Ischemia