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

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.

Study Overview

• Status: Recruiting
• Conditions: Ischemic Heart Disease
• Intervention / Treatment: Other: PM HeartIHD prediction

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?

• Study Type: Interventional
• Enrollment (Estimated): 8000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Henning Bundgaard, Professor; Phone Number: +4535450512; Email: henning.bundgaard@regionh.dk

Study Locations

• Denmark
  • Copenhagen Ø, Denmark, 2100
    • Recruiting
    • Department of Cardiology, The Heart Centre, Rigshospitalet Copenhagen University Hospital.
    • Contact: Henning Bundgaard, MD, DMSci; Phone Number: +4535450512; Email: henningbundgaard@dadlnet.dk
    • Principal Investigator: Henning Bundgaard, MD, PhD, DMSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; The one-year mortality prediction, calculated by the PM Heart algorithm, will not be available to the physician.
Experimental: Intervention; The one-year mortality prediction, calculated by the PM Heart algorithm, will be available to the physician.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Readmission(s) within 30 days of the randomization	Readmission(s) within 30 days of the randomization. Incl. information on the quantity, duration, cause, outcome etc.	Up to 30 days after randomization to the study.
Cardiovascular readmission(s) within 30 days of the randomization	Cardiovascular readmission(s) within 30 days of the randomization. Incl. information on the quantity, duration, cause, outcome etc.	Up to 30 days after randomization to the study.
Readmission(s) with acute coronary syndrome	Readmission(s) with acute coronary syndrome. Incl. information on the quantity, duration, cause, outcome etc.	From randomization to the study and up to 1 year hereafter
One-year survival	One-year survival	From randomization to the study and up to 1 year hereafter
Total number of days the primary hospitalization lasts	Length (i.e. total number of days) of the primary hospitalization (i.e. when the patient is randomized to the study).	From randomization to the study and up to 1 year hereafter
Total number of days at the hospital incl. hospitalizations during the first year after inclusion	Total number of days in hospital during the first year after inclusion	From randomization to the study and up to 1 year hereafter
Number of hospitalizations the first year	Number of hospitalizations the first year	From randomization to the study and up to 1 year hereafter
Number and type of performed cardiac investigations	Number and type of performed cardiac investigations; i.e. TTE, KAG, Heart-CT, Holter/R-tests, ECG, blood samples, etc.	From randomization to the study and up to 1 year hereafter
Number of cardiac follow-up consultations at the hospital	Number of cardiac follow-up consultations at the hospital	From randomization to the study and up to 1 year hereafter
Number of check-ups for cardiovascular reasons at the general practitioner	Number of check-ups for cardiovascular reasons at the general practitioner.	From randomization to the study and up to 1 year hereafter
Number of cardiovascular drugs at discharge	Number of cardiovascular drugs at discharge + after 1 year.	From randomization to the study and up to 1 year hereafter
Dosages (DDD) of drugs at discharge	Dosages (DDD) of drugs at discharge + after 1 year.	Up to 1 year after randomization to study.
Incidence of a) new ischemic events, b) arrhythmias, c) and/or heart failure	Incidence of a) new ischemic events, b) arrhythmias, c) and/or heart failure	Up to 1 year after randomization to study.
Health economic analyses of implementing the algorithm	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.	Up to 1 year after randomization to study.
The algorithm's reception and introduction in clinical use	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.	Before start of clinical study and up to 1 year after randomization to study.
The usability of the algorithm	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.	Before start of clinical study and up to 1 year after randomization to study.
How, and to what extend, is the algorithm used by the medical staff.	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".	Before start of clinical study and up to 1 year after randomization to study.

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark
• Collaborators: Region Capital Denmark; Region Zealand

Study record dates

Study Major Dates

• Study Start (Actual): September 18, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: August 18, 2023
• First Submitted That Met QC Criteria: September 4, 2023
• First Posted (Actual): September 13, 2023

Study Record Updates

• Last Update Posted (Actual): January 22, 2024
• Last Update Submitted That Met QC Criteria: January 19, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Ischemia
• Other Study ID Numbers: p-2023-14244

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No