Acute Coronary Syndrome Without ST Elevation on Electrocardiogram
Conditions
Keywords
chest pain, shortness of breath, high-sensitivity troponin, ECG changes, Myocardial infarction (MI), Pre-hospital care, Acute coronary syndrome without ST-segment elevation
Brief summary
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.
Interventions
None listed
Sponsors
Leipzig Heart Science gGmbH
Stiftung Institut für Herzinfarktforschung (evaluierendes Institut)
Herzzentrum Leipzig - Universitätsklinik für Kardiologie
Universitätsklinikum Hamburg-Eppendorf - Klinik 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
University Medical Center Hamburg-Eppendorf - Clinic for Cardiology University Medical Center Hamburg-Eppendorf
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
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Suspected myocardial infarction * Symptom onset \>30 minutes before arrival of emergency medical services * Written informed consent
Exclusion criteria
* 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 * Age \<18 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hospital-confirmed myocardial infarction | from March 2026 to Jun 2026 | The primary endpoint is hospital-confirmed myocardial infarction in patients referred to the PREDICT calibration study by emergency medical services with suspected acute coronary syndrome (ACS). |
Contacts
CONTACTHolger Thiele PD Dr., Prof. Dr.
CONTACTAlexander Jobs PD Dr., PD Dr.
STUDY_DIRECTORHolger Thiele Thiele, Prof. Dr.
University Clinic for Cardiology, Heart Center Leipzig
STUDY_CHAIRAlexander Jobs Jobs, PD Dr.
University Clinic for Cardiology, Heart Center Leipzig
STUDY_CHAIRRaphael Twerenbold Twerenbold, Prof. Dr.
University Heart & Vascular Center Hamburg
STUDY_CHAIRJohannes Neumann Neumann, PD Dr.
University Heart & Vascular Center Hamburg
Outcome results
None listed