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.

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Key information

Conditions

Acute Coronary Syndrome Without ST Elevation on Electrocardiogram Cardiovascular Diseases Chest Pain Dyspnea Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Hospital-confirmed myocardial infarction

Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Alexander Jobs PD Dr., PD Dr.

CONTACT

[email protected]

+49 341 865 1428

Holger Thiele PD Dr., Prof. Dr.

CONTACT

[email protected]

+49 341 865 14

Sponsors and collaborators

Lead sponsor

Leipzig Heart Science gGmbH

Other

Collaborators

Bundesvereinigung der Arbeitsgemeinschaften der Notärzte Deutschlands e.V.
Federal Association of Working Groups of Emergency Physicians in Germany
Herzzentrum Leipzig - Universitätsklinik für Kardiologie
Institut für Gesundheitsökonomie und Versorgungsforschung Medizinische Hochschule Brandenburg - Institut für Sozialmedizin und Epidemiologie
Institute for Health Economics and Health Services Research Brandenburg Medical School - Institute for Social Medicine and Epidemiology
Institute for Myocardial Infarction Research Foundation (evaluating institute)
Leipzig Heart Center - University Clinic for Cardiology
Scientific Institute of the AOK Federal Association
Stiftung Institut für Herzinfarktforschung (evaluierendes Institut)
The German Heart Foundation
Universitätsklinikum Hamburg-Eppendorf
Wissenschaftliches Institut der AOK Bundesverband

Registry information

Acronym: PREDICT

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2026
First posted: Feb 18, 2026
Registry last updated: Feb 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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