Calibration Study PREDICT - Prehospital Triage for Suspected Acute Coronary Syndrome Without ST-segment Elevation

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorLeipzig Heart Science gGmbH

About this trial

The PREDICT calibration study is a prospective, non-interventional trial aiming to adapt and calibrate the ACS-Pathfinder algorithm for prehospital triage of patients with suspected non-ST-elevation acute coronary syndrome (NSTE-ACS) in Germany. Approximately 304 patients will be enrolled by six emergency medical service (EMS) stations. All patients will receive standard care and an additional point-of-care troponin test (POCT) performed in the ambulance. Clinical and biomarker data will be collected using a study app, without influencing patient management. Follow-up will be conducted up to 90 days through telephone interviews and hospital record review.

The primary objective is to determine the true prevalence of myocardial infarction and calibrate the ACS-Pathfinder algorithm accordingly. Secondary objectives include assessing feasibility, workflow, acceptance, and data processes within the EMS as preparation for a subsequent cluster-randomized main study.

The study is coordinated by Prof. Holger Thiele (Heart Center Leipzig) with co-investigators from Leipzig and Hamburg. The sponsor is Leipzig Heart Science gGmbH. Study duration is planned from January to November 2026.

Eligibility criteria

Qualifiers

Suspected myocardial infarction

Symptom onset >30 minutes before arrival of emergency medical services

Written informed consent

Disqualifiers

STEMI on initial ECG

Unstable angina, hemodynamic instability, life-threatening arrhythmias, cardiac arrest

Non-ischemic causes requiring hospitalization

Emergency physician dispatch at the request of a primary care physician

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

No trial groups listed

Locations

This trial has no locations

Sponsors and collaborators

Leipzig Heart Science gGmbH

Lead sponsor

Stiftung Institut für Herzinfarktforschung (evaluierendes Institut)

Collaborator

Herzzentrum Leipzig - Universitätsklinik für Kardiologie

Collaborator

Universitätsklinikum Hamburg-Eppendorf

Collaborator

Institut für Gesundheitsökonomie und Versorgungsforschung Medizinische Hochschule Brandenburg - Institut für Sozialmedizin und Epidemiologie

Collaborator

The German Heart Foundation

Collaborator

Bundesvereinigung der Arbeitsgemeinschaften der Notärzte Deutschlands e.V.

Collaborator

Wissenschaftliches Institut der AOK Bundesverband

Collaborator

Institute for Myocardial Infarction Research Foundation (evaluating institute)

Collaborator

Leipzig Heart Center - University Clinic for Cardiology

Collaborator

Institute for Health Economics and Health Services Research Brandenburg Medical School - Institute for Social Medicine and Epidemiology

Collaborator

Federal Association of Working Groups of Emergency Physicians in Germany

Collaborator

Scientific Institute of the AOK Federal Association

Collaborator