Acute Coronary Syndrome Without ST Elevation on ElectrocardiogramPREDICTNCT07419139
Calibration Study PREDICT - Prehospital Triage for Suspected Acute Coronary Syndrome Without ST-segment Elevation
An observational study of Acute Coronary Syndrome Without ST Elevation on Electrocardiogram, run by Leipzig Heart Science gGmbH.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Coronary Syndrome Without ST Elevation on Electrocardiogram
- How many people
- 304 participants
- Where
- No sites listed yet
- Study dates
- Apr 2026to Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Suspected myocardial infarction
- Symptom onset >30 minutes before arrival of emergency medical services
- Written informed consent
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
- Keywords
- chest pain, shortness of breath, high-sensitivity troponin, ECG changes, Myocardial infarction (MI), Pre-hospital care, Acute coronary syndrome without ST-segment elevation
- Medical subject headings
- Chest Pain, Dyspnea, Myocardial Infarction
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: from March 2026 to Jun 2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study startApr 2026 (estimated)
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary Syndrome Without ST Elevation on ElectrocardiogramStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 304 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leipzig Heart Science gGmbH
- Sponsor type
- University, hospital or other
- Collaborators
- Stiftung Institut für Herzinfarktforschung (evaluierendes Institut), Herzzentrum Leipzig - Universitätsklinik für Kardiologie, Universitätsklinikum Hamburg-Eppendorf, Institut für Gesundheitsökonomie und Versorgungsforschung Medizinische Hochschule Brandenburg - Institut für Sozialmedizin und Epidemiologie, The German Heart Foundation, 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, 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
- Responsible party
- Sponsor
- Investigators
- Holger Thiele Thiele, Prof. Dr., Study director, University Clinic for Cardiology, Heart Center LeipzigAlexander Jobs Jobs, PD Dr., Study chair, University Clinic for Cardiology, Heart Center LeipzigRaphael Twerenbold Twerenbold, Prof. Dr., Study chair, University Heart & Vascular Center HamburgJohannes Neumann Neumann, PD Dr., Study chair, University Heart & Vascular Center Hamburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07419139
- Sponsor's protocol ID
- 2023-0315
- Acronym
- PREDICT
- Status last verified
- Feb 2026
- First submitted
- 10 Feb 2026
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Calibration Study PREDICT - Prehospital Triage for Suspected Acute Coronary Syndrome Without ST-segment Elevation
- ClinicalTrials.gov ID
- NCT07419139
- Acronym / sponsor ID
- PREDICT / 2023-0315
- Keywords
- chest pain, shortness of breath, high-sensitivity troponin, ECG changes, Myocardial infarction (MI), Pre-hospital care, Acute coronary syndrome without ST-segment elevation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 304 participants (estimated)
- Lead sponsor
- Leipzig Heart Science gGmbHUniversity, hospital or other
- Collaborators
- Stiftung Institut für Herzinfarktforschung (evaluierendes Institut), Herzzentrum Leipzig - Universitätsklinik für Kardiologie, Universitätsklinikum Hamburg-Eppendorf, Institut für Gesundheitsökonomie und Versorgungsforschung Medizinische Hochschule Brandenburg - Institut für Sozialmedizin und Epidemiologie, The German Heart Foundation, 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, 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
- Study start
- Apr 2026 (estimated)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 18 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Suspected myocardial infarction
- Symptom onset >30 minutes before arrival of emergency medical services
- Written informed consent
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Acute Coronary Syndrome Without ST Elevation on Electrocardiogram
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Acute Coronary Syndrome Without ST Elevation on Electrocardiogram, Acute Coronary Syndromes (ACS)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Holger Thiele Thiele, Prof. Dr. study director
University Clinic for Cardiology, Heart Center Leipzig
Alexander Jobs Jobs, PD Dr. study chair
University Clinic for Cardiology, Heart Center Leipzig
Raphael Twerenbold Twerenbold, Prof. Dr. study chair
University Heart & Vascular Center Hamburg
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndrome Without ST Elevation on Electrocardiogram, run by Leipzig Heart Science gGmbH.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Holger Thiele PD Dr., Prof. Dr. (+49 341 865 14, Holger.Thiele@medizin.uni-leipzig.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital-confirmed myocardial infarction (time frame: from March 2026 to Jun 2026). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026.