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RecruitingNCT06927791MALBECUpdated Apr 15, 2025

MAchine Learning to Boost the Early Diagnosis of Acute Cardiovascular Conditions

An observational study in Acute Cardiovascular Disease, ST-segment Elevation Myocardial Infarction (STEMI) and NSTEMI - Non-ST Segment Elevation MI, sponsored by University Hospital, Basel, Switzerland. Recruiting at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-15.

Sponsored by University Hospital, Basel, Switzerland · Observational

From the registry’s dates

  • Started Apr 2024; still recruiting 2 years 7 months later.
Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
200,000
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 26 studies in ST Elevation Myocardial Infarction with a site in Switzerland — 5 open to participants now, 7 under way, 1 of them phase 3. ST Elevation Myocardial Infarction · Switzerland.

Started
2024
with 1 other
Observational
5 of 26
2 open now
Registered
24th of 26
by date

Among the 26 studies in ST Elevation Myocardial Infarction with a site in Switzerland, this one is one of 2 that started in 2024, is one of 5 observational ones, and was the 24th registered.

ST Elevation Myocardial Infarction

850 studies on the registry are indexed under ST Elevation Myocardial Infarction; 197 are open to participants now.

Browse ST Elevation Myocardial Infarction studies →

Open to participants now

5 of the 26 studies in ST Elevation Myocardial Infarction with a site in Switzerland are open now. Recruiting first, the newest first:

All 5 open studies →

A study can be open while its sites in Switzerland have not opened yet or have stopped. Only those recruiting at a site in Switzerland →

Who these studies take

Of the 122 ST Elevation Myocardial Infarction studies recruiting now, 76 (62%) set no upper age limit and 20 (16%) stop at 75 or younger; 10 take children under 18; 9 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study 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 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:

  1. Develop and implement a clinical decision support tool that visualizes key diagnostic data.
  2. Train and validate ML models to diagnose acute cardiovascular diseases (ACVD).
  3. Compare ML model performance with existing diagnostic algorithms.
  4. Validate ML models in large international clinical trials.
  5. Integrate ML models into the electronic patient record at the University Hospital Basel.
03

Conditions studied

  • 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
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Dataset of about 200'000 extensively characterized patients enrolled in randomized controlled trials and observational studies are used

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Acute cardiovascular disease (ACVD)

Exclusion criteria

Exclusion Criteria

  • age \< 18 years old
  • patients presenting in cardiogenic shock
  • chronic terminal kidney failure requiring dialysis
05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
200,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • Patients with acute chest pain and/or acute dyspnoea

    Patients with acute chest pain and/or acute dyspnoea

    Other: Machine learning based development of a diagnostic tool for acute cardiovascular disease

Interventions

  • OtherMachine learning based development of a diagnostic tool for acute cardiovascular disease

    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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: During whole study duration of 3 years

  2. 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

    Time frame: During whole study duration of 3 years

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Apr 2024 (actual). Primary completion is estimated for Mar 2027, 35 months after the start.

Of 122 non-industry observational studies under ST Elevation Myocardial Infarction, half reached primary completion within 41 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 107. This study's planned 35 months is below that.

Counting every sponsor, half of 143 studies reached it within 38 months; a quarter within 20 and three quarters within 73.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 7, 2025
First posted
Apr 15, 2025
StartActual
Apr 1, 2024
Primary completionEst.
Mar 2027
CompletionEst.
Mar 2027
Last update
Apr 15, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 15, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06927791
Collaborators
University of Basel
Responsible party
Sponsor
First posted
Apr 15, 2025
Start date
Apr 1, 2024
Primary completion
Mar 2027 (estimated)
Completion
Mar 2027 (estimated)
Last update
Apr 15, 2025

Study contacts

Jasper Boeddinghaus, PD Dr. med.
Contact
jasper.boeddinghaus@usb.ch
+41 61 32 87897
Ivo Strebel, PhD
Contact
ivo.strebel@usb.ch
Christian Müller, Prof. Dr. med.
study director · University Hospital, Basel, Switzerland
Jasper Boeddinghaus, PD Dr. med.
principal investigator · University Hospital, Basel, Switzerland

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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