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

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.

NCT Number	NCT07419139
Lead Sponsor	Leipzig Heart Science gGmbH Collaborators: Stiftung Institut für Herzinfarktforschung (evaluierendes Institut), Herzzentrum Leipzig - Universitätsklinik für Kardiologie, Universitätsklinikum Hamburg-Eppendorf, Institut für Gesundheitsökonomie und Versorgungsforschung Medizinische Hochschule Brandenburg - Institut für Sozialmedizin und Epidemiologie, The German Heart Foundation, Bundesvereinigung der Arbeitsgemeinschaften der Notärzte Deutschlands e.V., Wissenschaftliches Institut der AOK Bundesverband, Institute for Myocardial Infarction Research Foundation (evaluating institute), Leipzig Heart Center - University Clinic for Cardiology, Institute for Health Economics and Health Services Research Brandenburg Medical School - Institute for Social Medicine and Epidemiology, Federal Association of Working Groups of Emergency Physicians in Germany, Scientific Institute of the AOK Federal Association
Conditions	Acute Coronary Syndrome Without ST Elevation on Electrocardiogram
Enrollment	304 participants
Start Date	2026-04
Primary Completion	2026-11 (estimated)
Study Completion	2026-11 (estimated)
Updated on ClinicalTrials.gov	2026-02-18