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

Starting soon

Conditions studied: Acute Coronary Syndrome Without ST Elevation on Electrocardiogram

In brief

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.

Key facts

Study ID

NCT07419139

Run by

Leipzig Heart Science gGmbH

People needed

304

Starts

2026-04-01

Expected to finish

2026-11-01

Last updated by the study team

2026-02-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Suspected myocardial infarction
• Symptom onset >30 minutes before arrival of emergency medical services
• Written informed consent

You may not qualify if…

• 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

Full record on ClinicalTrials.gov

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