Actively Recruiting
Clinical Implementation of a Novel Decision Support Tool in Patients With Ischemic Heart Disease
Led by Rigshospitalet, Denmark · Updated on 2024-01-22
8000
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
R
Rigshospitalet, Denmark
Lead Sponsor
R
Region Capital Denmark
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating the clinical usefulness of the PM-Heart algorithm (PMHeartIHD), a software tool designed to predict survival prognosis for patients hospitalized with ischemic heart disease (IHD) after coronary arteriography. The goal is to see if using this decision support system helps improve patient outcomes and reduce the risk of rehospitalization compared to standard treatment without the algorithm's input. Participants will be randomly assigned to one of two groups: one where the treating physician does not have access to the PM-Heart algorithm's one-year mortality prediction, and another where the physician receives this information to assist in treatment decisions. The algorithm offers a prognosis to support the physician's evaluation but does not give specific treatment instructions. The study monitors patients up to one year after randomization. During the study, researchers will track hospital readmissions, causes of death, length and number of hospital stays, cardiac investigations, follow-up consultations, medication use, and new cardiovascular events. They will also assess how the algorithm is received and used by medical staff, its usability, and related health economic impacts. The total participation time includes follow-up for one year after randomization.
CONDITIONS
Brief Title
Clinical Implementation of a Novel Decision Support Tool in Patients With Ischemic Heart Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Hospitalized patients in one of the involved cardiology departments
- Diagnosed with ischemic heart disease including stable, unstable angina, or myocardial infarction
- Significant coronary artery lesions or diffuse coronary artery disease shown on invasive coronary angiography during admission
You will not qualify if you...
- Under 18 years of age
- Living outside Denmark
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 year
Participants are randomized to either receive the PM HeartIHD algorithm prediction available to their physician to assist in treatment decisions, or receive standard care without the algorithm's prediction.
Follow-up visits may occur during the year after randomization
Duration - Up to 1 year after treatment
Participants are monitored for readmissions, survival, cardiac investigations, and cardiovascular health for up to one year after randomization.
Visits include hospital and general practitioner check-ups occurring over the year
Trial Site Locations
Total: 1 location
1
Department of Cardiology, The Heart Centre, Rigshospitalet Copenhagen University Hospital.
Copenhagen Ø, Denmark, 2100
Actively Recruiting
Research Team
H
Henning Bundgaard, Professor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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