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

NCT ID: NCT06033014

Last Updated: 2024-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

8000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-18

Study Completion Date

2026-12-31

Brief Summary

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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

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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?

Conditions

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Ischemic Heart Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention

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

Group Type EXPERIMENTAL

PM HeartIHD prediction

Intervention Type 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.

Interventions

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PM HeartIHD prediction

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Region Capital Denmark

OTHER

Sponsor Role collaborator

Region Zealand

OTHER

Sponsor Role collaborator

Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Henning Bundgaard

Professor of Cardiology, Consultant, MD, DMSc

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Copenhagen Ø, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Henning Bundgaard, Professor

Role: CONTACT

+4535450512

Facility Contacts

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Henning Bundgaard, MD, DMSci

Role: primary

+4535450512

Other Identifiers

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p-2023-14244

Identifier Type: -

Identifier Source: org_study_id

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