Ischemic Heart DiseasePM HeartNCT06033014
Clinical Implementation of a Novel Decision Support Tool in Patients With Ischemic Heart Disease
A study testing PM HeartIHD prediction in people with Ischemic Heart Disease, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Heart Disease
- What is being tested?
- PM HeartIHD prediction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8,000 participants
- Where
- 1 siteDenmark
- Study dates
- 18 Sep 2023to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- <18 years of age
- Living outside Denmark
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Department of Cardiology, The Heart Centre, Rigshospitalet Copenhagen University Hospital.
Copenhagen Ø, 2100
Henning Bundgaard, MD, DMSci, +4535450512, henningbundgaard@dadlnet.dk
Henning Bundgaard, MD, PhD, DMSc
About this study
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.
Read the 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?
- Conditions
- Ischemic Heart Disease
- Being tested
- PM HeartIHD prediction
- Medical subject headings
- Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PM HeartIHD predictionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: PM HeartIHD prediction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: 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.
Measured: From randomization to the study and up to 1 year hereafter
Secondary outcomes (17)
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.
Measured: 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.
Measured: 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.
Measured: From randomization to the study and up to 1 year hereafter
One-year survival
One-year survival
Measured: 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).
Measured: 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
Measured: From randomization to the study and up to 1 year hereafter
Number of hospitalizations the first year
Number of hospitalizations the first year
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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".
Measured: Before start of clinical study and up to 1 year after randomization to study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start18 Sep 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Region Capital Denmark, Region Zealand
- Responsible party
- Principal investigator, Henning Bundgaard, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06033014
- Sponsor's protocol ID
- p-2023-14244
- Acronym
- PM Heart
- Status last verified
- Jan 2024
- First submitted
- 18 Aug 2023
- Last updated
- 22 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Implementation of a Novel Decision Support Tool in Patients With Ischemic Heart Disease
- ClinicalTrials.gov ID
- NCT06033014
- Acronym / sponsor ID
- PM Heart / p-2023-14244
- Conditions
- Ischemic Heart Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 8,000 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Region Capital Denmark, Region Zealand
- Study start
- 18 Sep 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 13 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –The one-year mortality prediction, calculated by the PM Heart algorithm, will not be available to the physician. |
| Intervention | Experimental | Other: PM HeartIHD predictionThe one-year mortality prediction, calculated by the PM Heart algorithm, will be available to the physician. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- <18 years of age
- Living outside Denmark
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PM HeartIHD predictionThe 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. | Other | Intervention |
Primary outcome
Number and duration of readmissions within one month after randomization
Time frame: From randomization to the study and up to 1 year hereafter
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".
Number and cause of death (all-cause mortality) within one year after randomization
Time frame: From randomization to the study and up to 1 year hereafter
A composite outcome of a) readmissions within one month, and 2) all-cause mortality within one year - for patients randomized to the study.
17 secondary outcomes
Readmission(s) within 30 days of the randomization
Time frame: Up to 30 days after randomization to the study.
Cardiovascular readmission(s) within 30 days of the randomization
Time frame: Up to 30 days after randomization to the study.
Readmission(s) with acute coronary syndrome
Time frame: From randomization to the study and up to 1 year hereafter
One-year survival
Time frame: From randomization to the study and up to 1 year hereafter
Total number of days the primary hospitalization lasts
Time frame: 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
Time frame: From randomization to the study and up to 1 year hereafter
Number of hospitalizations the first year
Time frame: From randomization to the study and up to 1 year hereafter
Number and type of performed cardiac investigations
Time frame: From randomization to the study and up to 1 year hereafter
Number of cardiac follow-up consultations at the hospital
Time frame: From randomization to the study and up to 1 year hereafter
Number of check-ups for cardiovascular reasons at the general practitioner
Time frame: From randomization to the study and up to 1 year hereafter
Number of cardiovascular drugs at discharge
Time frame: From randomization to the study and up to 1 year hereafter
Dosages (DDD) of drugs at discharge
Time frame: Up to 1 year after randomization to study.
Incidence of a) new ischemic events, b) arrhythmias, c) and/or heart failure
Time frame: Up to 1 year after randomization to study.
Health economic analyses of implementing the algorithm
Time frame: Up to 1 year after randomization to study.
The algorithm's reception and introduction in clinical use
Time frame: Before start of clinical study and up to 1 year after randomization to study.
The usability of the algorithm
Time frame: 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.
Time frame: Before start of clinical study and up to 1 year after randomization to study.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PM HeartIHD prediction in people with Ischemic Heart Disease, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Henning Bundgaard, Professor (+4535450512, henning.bundgaard@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number and duration of readmissions within one month after randomization (time frame: From randomization to the study and up to 1 year hereafter). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2024.