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NCT07419139Not yet recruiting

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

Source: ClinicalTrials.gov · Last updated 18 Feb 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
304 (estimated)
First submitted
10 Feb 2026
Start date
Apr 2026
Primary completion date
Nov 2026
Lead sponsor
Leipzig Heart Science gGmbH
NCT number
NCT07419139

What you commit to

  • Study type: Observational
  • Planned participants: 304
  • From Apr 2026 to the primary completion date, Nov 2026
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Unstable angina, hemodynamic instability, life-threatening arrhythmias, cardiac arrest

Age

  • Age \<18 years

Other

  • STEMI on initial ECG
  • Non-ischemic causes requiring hospitalization
  • Emergency physician dispatch at the request of a primary care physician

Who the study is looking for

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

Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.