Acute Cardiovascular DiseaseMALBECNCT06927791
MAchine Learning to Boost the Early Diagnosis of Acute Cardiovascular Conditions
An observational study of Acute Cardiovascular Disease and ST-segment Elevation Myocardial Infarction (STEMI), run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
The research project aims to develop clinical decision support tools integrating established diagnostic variables and machine learning (ML) models for rapid diagnosis of acute life-threatening cardiovascular conditions in emergency department (ED) patients with chest pain or dyspnea with the ultimate goal of Improved… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Cardiovascular Disease, ST-segment Elevation Myocardial Infarction (STEMI), NSTEMI - Non-ST Segment Elevation MI
- What is being tested?
- Machine learning based development of a diagnostic tool for acute cardiovascular disease
- How many people
- 200,000 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Apr 2024to Mar 2027
- Phase
- Observational
- 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
Study population: Dataset of about 200'000 extensively characterized patients enrolled in randomized controlled trials and observational studies are used
Who may be able to join
- Acute cardiovascular disease (ACVD)
Who cannot join
- age < 18 years old
- patients presenting in cardiogenic shock
- chronic terminal kidney failure requiring dialysis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ivo Strebel, PhD contact
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Basel
Basel, 4031
Jasper Boeddinghaus, PD Dr. med, +41 61 32 87897, jasper.boeddinghaus@usb.ch
About this study
The research project aims to develop clinical decision support tools integrating established diagnostic variables and machine learning (ML) models for rapid diagnosis of acute life-threatening cardiovascular conditions in emergency department (ED) patients with chest pain or dyspnea with the ultimate goal of Improved diagnostic accuracy, faster patient management, and reduced medical errors.
Read the detailed description
Current State of Research in the Field
Acute cardiovascular disease (ACVD) is the leading cause of death in Switzerland and Europe, responsible for 29% of deaths in Switzerland and 36% across Europe. The increasing prevalence of ACVD, including acute myocardial infarction (AMI), acute heart failure (AHF), pulmonary embolism (PE), and acute aortic syndromes (AAS), places a significant burden on healthcare systems. Diagnosing these conditions in emergency departments (EDs) is challenging due to overlapping symptoms and the need for rapid, accurate decision-making.
The introduction of cardiovascular biomarkers, including high-sensitivity cardiac troponin, B-type natriuretic peptide, and D-dimer has revolutionized early diagnosis. These biomarkers, alongside clinical assessments and electrocardiograms (ECGs), are now essential diagnostic tools. However, current diagnostic algorithms have still tremendous limitations.
Recent advances in machine learning (ML) and deep learning (DL) offer opportunities to improve diagnosis. ML-based ECG interpretation and deep transferable learning (DTL) techniques could enhance diagnostic accuracy by integrating complex ECG and biomarker data. AutoML approaches can further refine these models, reducing human error and improving clinical workflows.
The research team has conducted multiple large-scale studies leading to significant advancements in cardiovascular biomarker research and precision medicine. Their contributions include:
- Validation of the MI3 model, which uses ML to improve NSTEMI
- Introduction of the BASEL ECG Score, a quantitative tool that enhances NSTEMI diagnosis.
- Validation of CoDE-ACS, an ML-based clinical decision support-tool that predicts the probability of NSTEMI more effectively than standard cardiac troponin thresholds.
The team is now focussing on integrating ECG data with biomarkers using AI/ML to enhance accuracy and automate decision-making. Collaboration with international experts has enabled the successful application of neural networks to ECG interpretation. The next steps include:
- Refining ML-based ECG interpretation to incorporate non-additive effects.
- Expanding ML models to include multiple cardiovascular conditions beyond AMI.
- Integrating these AI-driven tools into clinical workflows and electronic health records.
This research aims to revolutionise cardiovascular diagnostics by leveraging AI and ML for more precise, faster, and clinically relevant decision-making.
Objectives:
- Develop and implement a clinical decision support tool that visualizes key diagnostic data.
- Train and validate ML models to diagnose acute cardiovascular diseases (ACVD).
- Compare ML model performance with existing diagnostic algorithms.
- Validate ML models in large international clinical trials.
- Integrate ML models into the electronic patient record at the University Hospital Basel.
- Conditions
- Acute Cardiovascular Disease, ST-segment Elevation Myocardial Infarction (STEMI), NSTEMI - Non-ST Segment Elevation MI
- Being tested
- Machine learning based development of a diagnostic tool for acute cardiovascular disease
- Keywords
- Machine Learning, Clinical Decision Support Tool, Cardiac Biomarkers, Deep Transfer Learning (DTL), Artificial Intelligence, Acute cardiovascular conditions
- Medical subject headings
- ST Elevation Myocardial Infarction, Non-ST Elevated Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Machine learning based development of a diagnostic tool for acute cardiovascular diseaseOther
MALBEC will be delivered through five integrated work packages (WP) encompassing: (0) platform development and implementation, (1) data pooling, (2) model development, (3) performance comparison, (4) performance validation, and (5) platform plugin
| Study group | Role | What they receive |
|---|---|---|
| Patients with acute chest pain and/or acute dyspnoea | Patients with acute chest pain and/or acute dyspnoea Receives: Other: Machine learning based development of a diagnostic tool for acute cardiovascular disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Developing a clinical decision support tool
Developing and implementing a clinical decision support tool that integrates and visualizes results of established diagnostic variables in a dashboard
Measured: During whole study duration of 3 years
Validate machine learning (ML) models
Derive and validate ML models that integrate cardiac biomarkers with key clinical information and the digital 12-lead ECG to rapidly inform the diagnostic probability for six acute life-threatening cardiovascular conditions in patients presenting with acute chest pain and/or acute dyspnoea to the Emergency Department
Measured: During whole study duration of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2025
- Study start1 Apr 2024
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 200,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- University of Basel
- Responsible party
- Sponsor
- Investigators
- Christian Müller, Prof. Dr. med., Study director, University Hospital, Basel, SwitzerlandJasper Boeddinghaus, PD Dr. med., Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06927791
- Sponsor's protocol ID
- kt25boeddinghaus
- Acronym
- MALBEC
- Status last verified
- Apr 2025
- First submitted
- 7 Apr 2025
- Last updated
- 15 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MAchine Learning to Boost the Early Diagnosis of Acute Cardiovascular Conditions
- ClinicalTrials.gov ID
- NCT06927791
- Acronym / sponsor ID
- MALBEC / kt25boeddinghaus
- Conditions
- Acute Cardiovascular Disease, ST-segment Elevation Myocardial Infarction (STEMI), NSTEMI - Non-ST Segment Elevation MI
- Keywords
- Machine Learning, Clinical Decision Support Tool, Cardiac Biomarkers, Deep Transfer Learning (DTL), Artificial Intelligence, Acute cardiovascular conditions
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200,000 participants (estimated)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- University of Basel
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 15 Apr 2025 (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 research project aims to develop clinical decision support tools integrating established diagnostic variables and machine learning (ML) models for rapid diagnosis of acute life-threatening cardiovascular conditions in emergency department (ED) patients with chest pain or dyspnea with the ultimate goal of Improved diagnostic accuracy, faster patient management, and reduced medical errors.
Detailed description
Current State of Research in the Field
Acute cardiovascular disease (ACVD) is the leading cause of death in Switzerland and Europe, responsible for 29% of deaths in Switzerland and 36% across Europe. The increasing prevalence of ACVD, including acute myocardial infarction (AMI), acute heart failure (AHF), pulmonary embolism (PE), and acute aortic syndromes (AAS), places a significant burden on healthcare systems. Diagnosing these conditions in emergency departments (EDs) is challenging due to overlapping symptoms and the need for rapid, accurate decision-making.
The introduction of cardiovascular biomarkers, including high-sensitivity cardiac troponin, B-type natriuretic peptide, and D-dimer has revolutionized early diagnosis. These biomarkers, alongside clinical assessments and electrocardiograms (ECGs), are now essential diagnostic tools. However, current diagnostic algorithms have still tremendous limitations.
Recent advances in machine learning (ML) and deep learning (DL) offer opportunities to improve diagnosis. ML-based ECG interpretation and deep transferable learning (DTL) techniques could enhance diagnostic accuracy by integrating complex ECG and biomarker data. AutoML approaches can further refine these models, reducing human error and improving clinical workflows.
The research team has conducted multiple large-scale studies leading to significant advancements in cardiovascular biomarker research and precision medicine. Their contributions include:
- Validation of the MI3 model, which uses ML to improve NSTEMI
- Introduction of the BASEL ECG Score, a quantitative tool that enhances NSTEMI diagnosis.
- Validation of CoDE-ACS, an ML-based clinical decision support-tool that predicts the probability of NSTEMI more effectively than standard cardiac troponin thresholds.
The team is now focussing on integrating ECG data with biomarkers using AI/ML to enhance accuracy and automate decision-making. Collaboration with international experts has enabled the successful application of neural networks to ECG interpretation. The next steps include:
- Refining ML-based ECG interpretation to incorporate non-additive effects.
- Expanding ML models to include multiple cardiovascular conditions beyond AMI.
- Integrating these AI-driven tools into clinical workflows and electronic health records.
This research aims to revolutionise cardiovascular diagnostics by leveraging AI and ML for more precise, faster, and clinically relevant decision-making.
Objectives:
- Develop and implement a clinical decision support tool that visualizes key diagnostic data.
- Train and validate ML models to diagnose acute cardiovascular diseases (ACVD).
- Compare ML model performance with existing diagnostic algorithms.
- Validate ML models in large international clinical trials.
- Integrate ML models into the electronic patient record at the University Hospital Basel.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with acute chest pain and/or acute dyspnoea | – | Other: Machine learning based development of a diagnostic tool for acute cardiovascular diseasePatients with acute chest pain and/or acute dyspnoea |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Dataset of about 200'000 extensively characterized patients enrolled in randomized controlled trials and observational studies are used
Key inclusion criteria (1 listed)
- Acute cardiovascular disease (ACVD)
Key exclusion criteria (3 listed)
- age < 18 years old
- patients presenting in cardiogenic shock
- chronic terminal kidney failure requiring dialysis
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 |
|---|---|---|
| Machine learning based development of a diagnostic tool for acute cardiovascular diseaseMALBEC will be delivered through five integrated work packages (WP) encompassing: (0) platform development and implementation, (1) data pooling, (2) model development, (3) performance comparison, (4) performance validation, and (5) platform plugin | Other | Patients with acute chest pain and/or acute dyspnoea |
Primary outcome
Developing a clinical decision support tool
Time frame: During whole study duration of 3 years
Developing and implementing a clinical decision support tool that integrates and visualizes results of established diagnostic variables in a dashboard
Validate machine learning (ML) models
Time frame: During whole study duration of 3 years
Derive and validate ML models that integrate cardiac biomarkers with key clinical information and the digital 12-lead ECG to rapidly inform the diagnostic probability for six acute life-threatening cardiovascular conditions in patients presenting with acute chest pain and/or acute dyspnoea to the Emergency Department
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 15 Apr 2025.
- Individual participant dataSharing planned: No
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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.
Ivo Strebel, PhD contact
Christian Müller, Prof. Dr. med. study director
University Hospital, Basel, Switzerland
Jasper Boeddinghaus, PD Dr. med. principal investigator
University Hospital, Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Cardiovascular Disease and ST-segment Elevation Myocardial Infarction (STEMI), run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 1 inclusion and 3 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 15 Apr 2025. 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 Switzerland. 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 Jasper Boeddinghaus, PD Dr. med. (+41 61 32 87897, jasper.boeddinghaus@usb.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Developing a clinical decision support tool (time frame: During whole study duration of 3 years). 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 15 Apr 2025.