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

February 10, 2026 updated by: Leipzig Heart Science gGmbH

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.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

304

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
from March 2026 to Jun 2026

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Leipzig Heart Science gGmbH

Collaborators

The German Heart Foundation
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
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

Investigators

  • Study Director: Holger Thiele Thiele, Prof. Dr., University Clinic for Cardiology, Heart Center Leipzig
  • Study Chair: Alexander Jobs Jobs, PD Dr., University Clinic for Cardiology, Heart Center Leipzig
  • Study Chair: Raphael Twerenbold Twerenbold, Prof. Dr., University Heart & Vascular Center Hamburg
  • Study Chair: Johannes Neumann Neumann, PD Dr., University Heart & Vascular Center Hamburg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

February 10, 2026

First Submitted That Met QC Criteria

February 10, 2026

First Posted (Actual)

February 18, 2026

Study Record Updates

Last Update Posted (Actual)

February 18, 2026

Last Update Submitted That Met QC Criteria

February 10, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-0315

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Acute Coronary Syndrome Without ST Elevation on Electrocardiogram

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Serbia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe