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NCT Number: NCT06927791

MAchine Learning to Boost the Early Diagnosis of Acute Cardiovascular Conditions

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Acute cardiovascular disease (ACVD)

Exclusion criteria

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

Treatment and study plan

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

Other

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

Primary outcomes

  1. 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

  2. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Ivo Strebel, PhD

CONTACT

[email protected]

Jasper Boeddinghaus, PD Dr. med.

CONTACT

[email protected]

+41 61 32 87897

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Collaborators

  • University of Basel

Registry information

Acronym: MALBEC

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Apr 15, 2025
Registry last updated
Apr 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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