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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06033014
Other study ID # p-2023-14244
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 18, 2023
Est. completion date December 2026

Study information

Verified date January 2024
Source Rigshospitalet, Denmark
Contact Henning Bundgaard, Professor
Phone +4535450512
Email henning.bundgaard@regionh.dk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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?


Recruitment information / eligibility

Status Recruiting
Enrollment 8000
Est. completion date December 2026
Est. primary completion date December 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

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.

Locations

Country Name City State
Denmark Department of Cardiology, The Heart Centre, Rigshospitalet Copenhagen University Hospital. Copenhagen Ø

Sponsors (3)

Lead Sponsor Collaborator
Rigshospitalet, Denmark Region Capital Denmark, Region Zealand

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 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.
Secondary 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.
Secondary 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
Secondary One-year survival One-year survival From randomization to the study and up to 1 year hereafter
Secondary 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
Secondary 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
Secondary Number of hospitalizations the first year Number of hospitalizations the first year From randomization to the study and up to 1 year hereafter
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary Dosages (DDD) of drugs at discharge Dosages (DDD) of drugs at discharge + after 1 year. Up to 1 year after randomization to study.
Secondary 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.
Secondary 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.
Secondary 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.
Secondary 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.
Secondary 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.
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