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

NCT06033014 | Recruiting

• 1 other identifier: p-2023-14244
• Study Type: interventional
• Target: 8,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemic Heart Disease

Outcome Measures

Primary Outcomes (2)

• 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".

  From randomization to the study and up to 1 year hereafter

• 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.

  From randomization to the study and up to 1 year hereafter

Secondary Outcomes (17)

• Readmission(s) within 30 days of the randomization

  Up to 30 days after randomization to the study.

• Cardiovascular readmission(s) within 30 days of the randomization

  Up to 30 days after randomization to the study.

• Readmission(s) with acute coronary syndrome

  From randomization to the study and up to 1 year hereafter

• One-year survival

  From randomization to the study and up to 1 year hereafter

• Total number of days the primary hospitalization lasts

  From randomization to the study and up to 1 year hereafter

Study Arms (2)

Control

NO INTERVENTION

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

Intervention

EXPERIMENTAL

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

Other: PM HeartIHD prediction

Interventions

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \<18 years of age
• Living outside Denmark

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Region Capital Denmark: collaborator
• Region Zealand: collaborator

Study Sites (1)

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

Copenhagen Ø, 2100, Denmark

RECRUITING

MeSH Terms

Conditions

Myocardial Ischemia

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Central Study Contacts

Henning Bundgaard, Professor

CONTACT

+4535450512; henning.bundgaard@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Cardiology, Consultant, MD, DMSc

Study Record Dates

• First Submitted: August 18, 2023
• First Posted: September 13, 2023
• Study Start: September 18, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 22, 2024

Record last verified: 2024-01

Locations

DK (1)