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Clinical Implementation of a Novel Decision Support Tool in Patients With Ischemic Heart Disease (PM Heart)

Primary Purpose

Ischemic Heart Disease

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
PM HeartIHD prediction
Sponsored by
Rigshospitalet, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Ischemic Heart Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Hospitalized patients in one of the involved departments of cardiology (see below) with; Ischemic heart disease; the clinical presentation may be stable, worsening/unstable angina, non-ST-elevation myocardial infarction or ST-elevation myocardial infarction, and with - Significant coronary artery lesions or diffuse coronary artery disease on invasive coronary angiography during the admission Exclusion Criteria: <18 years of age Living outside Denmark

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Control

    Intervention

    Arm Description

    The one-year mortality prediction, calculated by the PM Heart algorithm, will not be available to the physician.

    The one-year mortality prediction, calculated by the PM Heart algorithm, will be available to the physician.

    Outcomes

    Primary Outcome Measures

    Number and duration of readmissions within one month after randomization
    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".
    Number and cause of death (all-cause mortality) within one year after randomization
    A composite outcome of a) readmissions within one month, and 2) all-cause mortality within one year - for patients randomized to the study.

    Secondary Outcome Measures

    Readmission(s) within 30 days of the randomization
    Readmission(s) within 30 days of the randomization. Incl. information on the quantity, duration, cause, outcome etc.
    Cardiovascular readmission(s) within 30 days of the randomization
    Cardiovascular readmission(s) within 30 days of the randomization. Incl. information on the quantity, duration, cause, outcome etc.
    Readmission(s) with acute coronary syndrome
    Readmission(s) with acute coronary syndrome. Incl. information on the quantity, duration, cause, outcome etc.
    One-year survival
    One-year survival
    Total number of days the primary hospitalization lasts
    Length (i.e. total number of days) of the primary hospitalization (i.e. when the patient is randomized to the study).
    Total number of days at the hospital incl. hospitalizations during the first year after inclusion
    Total number of days in hospital during the first year after inclusion
    Number of hospitalizations the first year
    Number of hospitalizations the first year
    Number and type of performed cardiac investigations
    Number and type of performed cardiac investigations; i.e. TTE, KAG, Heart-CT, Holter/R-tests, ECG, blood samples, etc.
    Number of cardiac follow-up consultations at the hospital
    Number of cardiac follow-up consultations at the hospital
    Number of check-ups for cardiovascular reasons at the general practitioner
    Number of check-ups for cardiovascular reasons at the general practitioner.
    Number of cardiovascular drugs at discharge
    Number of cardiovascular drugs at discharge + after 1 year.
    Dosages (DDD) of drugs at discharge
    Dosages (DDD) of drugs at discharge + after 1 year.
    Incidence of a) new ischemic events, b) arrhythmias, c) and/or heart failure
    Incidence of a) new ischemic events, b) arrhythmias, c) and/or heart failure
    Health economic analyses of implementing the algorithm
    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.
    The algorithm's reception and introduction in clinical use
    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.
    The usability of the algorithm
    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.
    How, and to what extend, is the algorithm used by the medical staff.
    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".

    Full Information

    First Posted
    August 18, 2023
    Last Updated
    September 4, 2023
    Sponsor
    Rigshospitalet, Denmark
    Collaborators
    Region Capital Denmark, Region Zealand
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06033014
    Brief Title
    Clinical Implementation of a Novel Decision Support Tool in Patients With Ischemic Heart Disease
    Acronym
    PM Heart
    Official Title
    Clinical Implementation of a Novel Decision Support Tool in Patients With Ischemic Heart Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 2023 (Anticipated)
    Primary Completion Date
    December 2026 (Anticipated)
    Study Completion Date
    December 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Rigshospitalet, Denmark
    Collaborators
    Region Capital Denmark, Region Zealand

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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?

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ischemic Heart Disease

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    8000 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    The one-year mortality prediction, calculated by the PM Heart algorithm, will not be available to the physician.
    Arm Title
    Intervention
    Arm Type
    Experimental
    Arm Description
    The one-year mortality prediction, calculated by the PM Heart algorithm, will be available to the physician.
    Intervention Type
    Other
    Intervention Name(s)
    PM HeartIHD prediction
    Intervention 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.
    Primary Outcome Measure Information:
    Title
    Number and duration of readmissions within one month after randomization
    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".
    Time Frame
    From randomization to the study and up to 1 year hereafter
    Title
    Number and cause of death (all-cause mortality) within one year after randomization
    Description
    A composite outcome of a) readmissions within one month, and 2) all-cause mortality within one year - for patients randomized to the study.
    Time Frame
    From randomization to the study and up to 1 year hereafter
    Secondary Outcome Measure Information:
    Title
    Readmission(s) within 30 days of the randomization
    Description
    Readmission(s) within 30 days of the randomization. Incl. information on the quantity, duration, cause, outcome etc.
    Time Frame
    Up to 30 days after randomization to the study.
    Title
    Cardiovascular readmission(s) within 30 days of the randomization
    Description
    Cardiovascular readmission(s) within 30 days of the randomization. Incl. information on the quantity, duration, cause, outcome etc.
    Time Frame
    Up to 30 days after randomization to the study.
    Title
    Readmission(s) with acute coronary syndrome
    Description
    Readmission(s) with acute coronary syndrome. Incl. information on the quantity, duration, cause, outcome etc.
    Time Frame
    From randomization to the study and up to 1 year hereafter
    Title
    One-year survival
    Description
    One-year survival
    Time Frame
    From randomization to the study and up to 1 year hereafter
    Title
    Total number of days the primary hospitalization lasts
    Description
    Length (i.e. total number of days) of the primary hospitalization (i.e. when the patient is randomized to the study).
    Time Frame
    From randomization to the study and up to 1 year hereafter
    Title
    Total number of days at the hospital incl. hospitalizations during the first year after inclusion
    Description
    Total number of days in hospital during the first year after inclusion
    Time Frame
    From randomization to the study and up to 1 year hereafter
    Title
    Number of hospitalizations the first year
    Description
    Number of hospitalizations the first year
    Time Frame
    From randomization to the study and up to 1 year hereafter
    Title
    Number and type of performed cardiac investigations
    Description
    Number and type of performed cardiac investigations; i.e. TTE, KAG, Heart-CT, Holter/R-tests, ECG, blood samples, etc.
    Time Frame
    From randomization to the study and up to 1 year hereafter
    Title
    Number of cardiac follow-up consultations at the hospital
    Description
    Number of cardiac follow-up consultations at the hospital
    Time Frame
    From randomization to the study and up to 1 year hereafter
    Title
    Number of check-ups for cardiovascular reasons at the general practitioner
    Description
    Number of check-ups for cardiovascular reasons at the general practitioner.
    Time Frame
    From randomization to the study and up to 1 year hereafter
    Title
    Number of cardiovascular drugs at discharge
    Description
    Number of cardiovascular drugs at discharge + after 1 year.
    Time Frame
    From randomization to the study and up to 1 year hereafter
    Title
    Dosages (DDD) of drugs at discharge
    Description
    Dosages (DDD) of drugs at discharge + after 1 year.
    Time Frame
    Up to 1 year after randomization to study.
    Title
    Incidence of a) new ischemic events, b) arrhythmias, c) and/or heart failure
    Description
    Incidence of a) new ischemic events, b) arrhythmias, c) and/or heart failure
    Time Frame
    Up to 1 year after randomization to study.
    Title
    Health economic analyses of implementing the algorithm
    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.
    Time Frame
    Up to 1 year after randomization to study.
    Title
    The algorithm's reception and introduction in clinical use
    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.
    Time Frame
    Before start of clinical study and up to 1 year after randomization to study.
    Title
    The usability of the algorithm
    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.
    Time Frame
    Before start of clinical study and up to 1 year after randomization to study.
    Title
    How, and to what extend, is the algorithm used by the medical staff.
    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".
    Time Frame
    Before start of clinical study and up to 1 year after randomization to study.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Hospitalized patients in one of the involved departments of cardiology (see below) with; Ischemic heart disease; the clinical presentation may be stable, worsening/unstable angina, non-ST-elevation myocardial infarction or ST-elevation myocardial infarction, and with - Significant coronary artery lesions or diffuse coronary artery disease on invasive coronary angiography during the admission Exclusion Criteria: <18 years of age Living outside Denmark

    12. IPD Sharing Statement

    Learn more about this trial

    Clinical Implementation of a Novel Decision Support Tool in Patients With Ischemic Heart Disease

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