NCT06927791

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200,000

participants targeted

Target at P75+ for all trials

Timeline
9mo left

Started Apr 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress72%
Apr 2024Mar 2027

Study Start

First participant enrolled

April 1, 2024

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

April 7, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 15, 2025

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

April 15, 2025

Status Verified

April 1, 2025

Enrollment Period

2.9 years

First QC Date

April 7, 2025

Last Update Submit

April 7, 2025

Conditions

Keywords

Machine LearningClinical Decision Support ToolCardiac BiomarkersDeep Transfer Learning (DTL)Artificial IntelligenceAcute cardiovascular conditions

Outcome Measures

Primary Outcomes (2)

  • 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

    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

    During whole study duration of 3 years

Study Arms (1)

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

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

Patients with acute chest pain and/or acute dyspnoea

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Acute cardiovascular disease (ACVD)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Basel

Basel, 4031, Switzerland

RECRUITING

MeSH Terms

Conditions

ST Elevation Myocardial InfarctionNon-ST Elevated Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Christian Müller, Prof. Dr. med.

    University Hospital, Basel, Switzerland

    STUDY DIRECTOR
  • Jasper Boeddinghaus, PD Dr. med.

    University Hospital, Basel, Switzerland

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jasper Boeddinghaus, PD Dr. med.

CONTACT

Ivo Strebel, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2025

First Posted

April 15, 2025

Study Start

April 1, 2024

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

April 15, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations