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

Rigshospitalet

Status: Enrolling

Conditions: Ischemic Heart Disease

Treatments: Other: PM HeartIHD prediction

Study type: Interventional

Funder types: Other

Identifiers

NCT06033014

p-2023-14244

Details and patient eligibility

About

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.

Full 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?

Enrollment: 8,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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8,000 participants in 2 patient groups

Control

No Intervention group

Description:

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

Intervention

Experimental group

Description:

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

Treatment:

Other: PM HeartIHD prediction