Clinical trial NCT06033014: Clinical Implementation of a Novel Decision Support Tool in Patients With Ischemic Heart Disease
Official title: Clinical Implementation of a Novel Decision Support Tool in Patients With Ischemic Heart Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ischemic Heart Disease
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Region Capital Denmark
name: Region Zealand
First posted: 2023-09-13
Enrollment: 8000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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?

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

Primary outcomes:
measure: Number and duration of readmissions within one month after randomization
timeFrame: From randomization to the study and up to 1 year hereafter
measure: Number and cause of death (all-cause mortality) within one year after randomization
timeFrame: From randomization to the study and up to 1 year hereafter
Secondary outcomes:
measure: Readmission(s) within 30 days of the randomization
timeFrame: Up to 30 days after randomization to the study.
measure: Cardiovascular readmission(s) within 30 days of the randomization
timeFrame: Up to 30 days after randomization to the study.
measure: Readmission(s) with acute coronary syndrome
timeFrame: From randomization to the study and up to 1 year hereafter
measure: One-year survival
timeFrame: From randomization to the study and up to 1 year hereafter
measure: Total number of days the primary hospitalization lasts
timeFrame: From randomization to the study and up to 1 year hereafter
measure: Total number of days at the hospital incl. hospitalizations during the first year after inclusion
timeFrame: From randomization to the study and up to 1 year hereafter
measure: Number of hospitalizations the first year
timeFrame: From randomization to the study and up to 1 year hereafter
measure: Number and type of performed cardiac investigations
timeFrame: From randomization to the study and up to 1 year hereafter
measure: Number of cardiac follow-up consultations at the hospital
timeFrame: From randomization to the study and up to 1 year hereafter
measure: Number of check-ups for cardiovascular reasons at the general practitioner
timeFrame: From randomization to the study and up to 1 year hereafter
measure: Number of cardiovascular drugs at discharge
timeFrame: From randomization to the study and up to 1 year hereafter
measure: Dosages (DDD) of drugs at discharge
timeFrame: Up to 1 year after randomization to study.
measure: Incidence of a) new ischemic events, b) arrhythmias, c) and/or heart failure
timeFrame: Up to 1 year after randomization to study.
measure: Health economic analyses of implementing the algorithm
timeFrame: Up to 1 year after randomization to study.
measure: The algorithm's reception and introduction in clinical use
timeFrame: Before start of clinical study and up to 1 year after randomization to study.
measure: The usability of the algorithm
timeFrame: Before start of clinical study and up to 1 year after randomization to study.
measure: How, and to what extend, is the algorithm used by the medical staff.
timeFrame: Before start of clinical study and up to 1 year after randomization to study.
Other outcomes:
Locations:
city: Copenhagen Ø
country: Denmark
facility: Department of Cardiology, The Heart Centre, Rigshospitalet Copenhagen University Hospital.
Study officials:
References: