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NCT Number: NCT06033014

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

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.

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Key information

Conditions

Ischemic Heart Disease Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Cardiology, The Heart Centre, Rigshospitalet Copenhagen University Hospital.

Copenhagen Ø, 2100, Denmark

Location status: Recruiting

Location contact

Henning Bundgaard, MD, DMSci

CONTACT

[email protected]

+4535450512

Henning Bundgaard, MD, PhD, DMSc

PRINCIPAL_INVESTIGATOR

About this study

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?

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PM HeartIHD prediction

Other

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 outcomes

  1. Number and duration of readmissions within one month after randomization

    Time frame: From randomization to the study and up to 1 year hereafter

    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".

  2. 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

    A composite outcome of a) readmissions within one month, and 2) all-cause mortality within one year - for patients randomized to the study.

Secondary outcomes

  1. Readmission(s) within 30 days of the randomization

    Time frame: Up to 30 days after randomization to the study.

    Readmission(s) within 30 days of the randomization. Incl. information on the quantity, duration, cause, outcome etc.

  2. Cardiovascular readmission(s) within 30 days of the randomization

    Time frame: Up to 30 days after randomization to the study.

    Cardiovascular readmission(s) within 30 days of the randomization. Incl. information on the quantity, duration, cause, outcome etc.

  3. Readmission(s) with acute coronary syndrome

    Time frame: From randomization to the study and up to 1 year hereafter

    Readmission(s) with acute coronary syndrome. Incl. information on the quantity, duration, cause, outcome etc.

  4. One-year survival

    Time frame: From randomization to the study and up to 1 year hereafter

    One-year survival

  5. Total number of days the primary hospitalization lasts

    Time frame: From randomization to the study and up to 1 year hereafter

    Length (i.e. total number of days) of the primary hospitalization (i.e. when the patient is randomized to the study).

  6. 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

    Total number of days in hospital during the first year after inclusion

  7. Number of hospitalizations the first year

    Time frame: From randomization to the study and up to 1 year hereafter

    Number of hospitalizations the first year

  8. Number and type of performed cardiac investigations

    Time frame: From randomization to the study and up to 1 year hereafter

    Number and type of performed cardiac investigations; i.e. TTE, KAG, Heart-CT, Holter/R-tests, ECG, blood samples, etc.

  9. Number of cardiac follow-up consultations at the hospital

    Time frame: From randomization to the study and up to 1 year hereafter

    Number of cardiac follow-up consultations at the hospital

  10. Number of check-ups for cardiovascular reasons at the general practitioner

    Time frame: From randomization to the study and up to 1 year hereafter

    Number of check-ups for cardiovascular reasons at the general practitioner.

  11. Number of cardiovascular drugs at discharge

    Time frame: From randomization to the study and up to 1 year hereafter

    Number of cardiovascular drugs at discharge + after 1 year.

  12. Dosages (DDD) of drugs at discharge

    Time frame: Up to 1 year after randomization to study.

    Dosages (DDD) of drugs at discharge + after 1 year.

  13. Incidence of a) new ischemic events, b) arrhythmias, c) and/or heart failure

    Time frame: Up to 1 year after randomization to study.

    Incidence of a) new ischemic events, b) arrhythmias, c) and/or heart failure

  14. Health economic analyses of implementing the algorithm

    Time frame: Up to 1 year after randomization to study.

    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.

  15. 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.

    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.

  16. The usability of the algorithm

    Time frame: Before start of clinical study and up to 1 year after randomization to study.

    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.

  17. 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.

    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".

Study contacts

Contact information is provided by the study sponsor or research team.

Henning Bundgaard, Professor

CONTACT

[email protected]

+4535450512

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

  • Region Capital Denmark
  • Region Zealand

Registry information

Acronym: PM Heart

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Sep 13, 2023
Registry last updated
Jan 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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