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| Name | Class |
|---|---|
| Stiftung Institut für Herzinfarktforschung (evaluierendes Institut) | UNKNOWN |
| Herzzentrum Leipzig - Universitätsklinik für Kardiologie | UNKNOWN |
| Universitätsklinikum Hamburg-Eppendorf | OTHER |
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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.
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| Measure | Description | Time Frame |
|---|---|---|
| Hospital-confirmed myocardial infarction | 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). | from March 2026 to Jun 2026 |
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Inclusion Criteria:
Exclusion Criteria:
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The study population includes adult patients with suspected myocardial infarction who are attended by emergency medical services (EMS). Eligible participants must have symptom onset more than 30 minutes before EMS arrival and be able to provide written informed consent.
Patients will be excluded if they present with ST-elevation myocardial infarction (STEMI) on the initial ECG, unstable angina, hemodynamic instability, life-threatening arrhythmias, or cardiac arrest. Additional exclusion criteria include non-ischemic conditions requiring hospital admission, EMS deployment requested by a primary care physician, and age under 18 years.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Holger Thiele PD Dr., Prof. Dr. | Contact | +49 341 865 14 | Holger.Thiele@medizin.uni-leipzig.de | |
| Alexander Jobs PD Dr., PD Dr. | Contact | +49 341 865 1428 | alexander.jobs@medizin.uni-leipzig.de |
| Name | Affiliation | Role |
|---|---|---|
| Holger Thiele Thiele, Prof. Dr. | University Clinic for Cardiology, Heart Center Leipzig | Study Director |
| Alexander Jobs Jobs, PD Dr. | University Clinic for Cardiology, Heart Center Leipzig | Study Chair |
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| ID | Term |
|---|---|
| D002637 | Chest Pain |
| D004417 | Dyspnea |
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Institut für Gesundheitsökonomie und Versorgungsforschung Medizinische Hochschule Brandenburg - Institut für Sozialmedizin und Epidemiologie | UNKNOWN |
| The German Heart Foundation | OTHER |
| Bundesvereinigung der Arbeitsgemeinschaften der Notärzte Deutschlands e.V. | UNKNOWN |
| Wissenschaftliches Institut der AOK Bundesverband | UNKNOWN |
| Institute for Myocardial Infarction Research Foundation (evaluating institute) | UNKNOWN |
| Leipzig Heart Center - University Clinic for Cardiology | UNKNOWN |
| Institute for Health Economics and Health Services Research Brandenburg Medical School - Institute for Social Medicine and Epidemiology | UNKNOWN |
| Federal Association of Working Groups of Emergency Physicians in Germany | UNKNOWN |
| Scientific Institute of the AOK Federal Association | UNKNOWN |
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| Raphael Twerenbold Twerenbold, Prof. Dr. | University Heart & Vascular Center Hamburg | Study Chair |
| Johannes Neumann Neumann, PD Dr. | University Heart & Vascular Center Hamburg | Study Chair |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D009336 | Necrosis |