Myocardial Infarction (MI)Pre-POCT TnINCT07563998
Prehospital Point-of-Care Hs-Troponin I for Rule-Out of Acute Myocardial Infarction in Patients Without ST-Segment Elevation
An observational study of Myocardial Infarction (MI) and Acute Coronary Syndromes (ACS), run by Central Denmark Region at 1 site in Denmark.
Trial summary
People who call emergency medical services (EMS) with chest pain or other possible heart-related symptoms are often taken to hospital for further testing. However, only a small proportion of these patients are ultimately diagnosed with a serious heart condition such as a heart attack. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction (MI), Acute Coronary Syndromes (ACS)
- What is being tested?
- Prehospital high-sensitivity cardiac troponin I measurement
- How many people
- 500 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jul 2026to 30 Jun 2027
- Phase
- Observational
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
- No healthy volunteers
- Adult, Older adult
Study population: Patients are recruited from the prehospital emergency medical services (EMS) system in the Central Denmark Region, Denmark. Participants are identified during routine ambulance missions by EMS personnel in units equipped with point-of-care testing (POCT) devices and trained in study procedures. The study population reflects real-world prehospital patients encountered in a publicly funded, tax-supported healthcare system with universal access to emergency care. Patients are included consecutively during the study period based on operational availability of participating EMS units.
Who may be able to join
- Age 18 years or older
- Assessed by one of the participating EMS units equipped for POCT sampling
- Presentation with symptoms suggestive of acute coronary syndrome
- Planned transport to hospital for further evaluation
Who cannot join
- ST-segment elevation on prehospital electrocardiogram
- Clinical condition requiring immediate life-saving intervention precluding study procedures
- Interhospital transport
- Prior inclusion in the study within 30 days
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Prehospital Emergency Medical Services, Central Denamrk Region
Aarhus N, 8200
About this study
Official title: Prehospital Point-of-Care High-Sensitivity Troponin I for Rule-Out of Acute Myocardial Infarction in Suspected Non-ST-Segment Elevation Acute Coronary Syndrome: A Pilot Study
People who call emergency medical services (EMS) with chest pain or other possible heart-related symptoms are often taken to hospital for further testing. However, only a small proportion of these patients are ultimately diagnosed with a serious heart condition such as a heart attack. This means that many patients undergo hospital transport and evaluation even though their risk is low.
In hospitals, a blood test called high-sensitivity cardiac troponin is commonly used to help diagnose or rule out heart attacks. It is not yet well established whether this type of test can be used safely and effectively earlier, in the prehospital setting.
Read more
This study will investigate whether it is feasible to measure high-sensitivity troponin in the ambulance and how well the test can identify patients at low risk of serious heart conditions. A small blood sample will be taken as part of routine care and analyzed using a portable device. The test result will not be used to guide treatment or decisions during the study.
The study will assess how well the test predicts heart-related events within 30 days and how practical it is to perform the test in real-life emergency settings. The results may help guide future research on how to improve early assessment and decision-making for patients with suspected heart disease.
Read the detailed description
This is a prospective observational diagnostic accuracy and feasibility study conducted in the Central Denmark Region.
Adult patients assessed by participating emergency medical services (EMS) units with symptoms suggestive of acute coronary syndrome (ACS), without ST-segment elevation on the prehospital electrocardiogram, and managed with planned transport to hospital are eligible for inclusion.
During routine EMS assessment, a venous blood sample (<0.5 mL) is obtained and analyzed using a portable point-of-care device for measurement of high-sensitivity cardiac troponin I (hs-TnI). The measurement is performed according to manufacturer instructions and local procedures. Troponin values are recorded for research purposes only and are not used to guide clinical decision-making. EMS personnel are not provided with interpretation guidance or clinical thresholds for hs-TnI.
Clinical assessment, treatment, triage, and transport decisions follow standard regional protocols and are independent of study participation.
Clinical data are obtained from prehospital records and hospital electronic health records. Final diagnoses, including acute coronary syndrome, are determined based on standard clinical evaluation, including serial in-hospital troponin measurements and other diagnostic procedures as clinically indicated.
The primary analysis evaluates the diagnostic performance of prehospital hs-TnI for identifying acute coronary syndrome and predicting major adverse cardiac events within 30 days. Diagnostic performance will be reported using sensitivity, specificity, positive and negative predictive values, likelihood ratios, and area under the receiver operating characteristic curve.
Secondary analyses assess associations between hs-TnI concentrations and clinical outcomes, including hospital admission, length of stay, coronary angiography, coronary revascularization, and 30-day mortality.
Feasibility outcomes include the proportion of successful blood sampling, the proportion of valid measurements, and the time from patient contact to availability of the biomarker result.
The study is designed to generate feasibility and diagnostic accuracy data to inform the design and statistical planning of future interventional studies in the prehospital setting.
The study has been assessed by The Central Denmark Region Committees on Health Research Ethics, which determined that the project does not require notification or approval under Danish legislation.
- Being tested
- Prehospital high-sensitivity cardiac troponin I measurement
- Keywords
- Prehospital, Emergency Medical Services, Point-of-Care Testing, POCT, High-Sensitivity Troponin I, Chest Pain, Non-ST Elevation, Diagnostic Accuracy, Risk Stratification, Major Adverse Cardiac Events, MACE
- Medical subject headings
- Myocardial Infarction, Acute Coronary Syndrome, Chest Pain, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prehospital high-sensitivity cardiac troponin I measurementDiagnostic test
Also called hs-TnI, Point-of-care troponin, i-STAT hs-TnI
Prehospital measurement of high-sensitivity cardiac troponin I (hs-TnI) using a point-of-care device during routine emergency medical services (EMS) assessment. Blood samples are analyzed according to manufacturer instructions and local procedures. The test is performed for research purposes only, and results are not available for clinical decision-making and do not influence patient management.
| Study group | Role | What they receive |
|---|---|---|
| Patients with suspected non-ST-segment elevation acute coronary syndrome (NSTE-ACS) | Adult patients assessed by participating emergency medical services (EMS) units with symptoms suggestive of acute coronary syndrome (ACS), in whom ST-segment elevation myocardial infarction (STEMI) is not identified on the prehospital electrocardiogram, and who are managed with planned transport to hospital for further evaluation. Patients undergo prehospital blood sampling for high-sensitivity cardiac troponin I (hs-TnI) measurement using a point-of-care device. Clinical management, triage, and transport decisions are not influenced by study participation or biomarker results. Receives: Diagnostic Test: Prehospital high-sensitivity cardiac troponin I measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiac events (MACE) within 30 days
Composite outcome including acute myocardial infarction, coronary revascularization, or cardiovascular death within 30 days of the index emergency medical services contact.
Measured: 30 days
Secondary outcomes (5)
Final diagnosis of acute coronary syndrome
Final hospital diagnosis of acute coronary syndrome based on standard clinical evaluation, including serial cardiac troponin measurements and other diagnostic procedures as clinically indicated.
Measured: 24 hours
All-cause 30-day mortality
Death from any cause within 30 days of the index emergency medical services contact.
Measured: 30 days
Coronary revascularization within 30 days
Percutaneous coronary intervention or coronary artery bypass grafting performed within 30 days of the index emergency medical services contact.
Measured: 30 days
Diagnostic performance of prehospital hs-TnI for acute coronary syndrome
Diagnostic performance of prehospital high-sensitivity cardiac troponin I for identifying acute coronary syndrome, reported as sensitivity, specificity, positive and negative predictive values, likelihood ratios, and area under the receiver operating characteristic curve.
Measured: 24 hours
Diagnostic performance of prehospital hs-TnI for 30-day MACE
Diagnostic performance of prehospital high-sensitivity cardiac troponin I for predicting major adverse cardiac events within 30 days, reported as sensitivity, specificity, positive and negative predictive values, likelihood ratios, and area under the receiver operating characteristic curve.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2026
- Study start1 Jul 2026
- Primary completion14 May 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Myocardial Infarction (MI)Studies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Denmark Region
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martin F Gude, MD, PhD, Principal investigator, Central Denmark Region
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07563998
- Sponsor's protocol ID
- 1-10-72-8-26
- Acronym
- Pre-POCT TnI
- Status last verified
- Aug 2026
- First submitted
- 26 Apr 2026
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made publicly available due to Danish data protection legislation (GDPR) and regional regulations governing the use of health data. The study relies on linked prehospital and hospital registry data obtained under specific approvals, which do not permit sharing of individual-level data outside the secure research environment. Data access is restricted to authorized personnel. Aggregated and anonymized results may be shared upon reasonable request and subject to relevant approvals.
Publications
Stopyra JP, Snavely AC, Scheidler JF, Smith LM, Nelson RD, Winslow JE, Pomper GJ, Ashburn NP, Hendley NW, Riley RF, Koehler LE, Miller CD, Mahler SA. Point-of-Care Troponin Testing during Ambulance Transport to Detect Acute Myocardial Infarction. Prehosp Emerg Care. 2020 Nov-Dec;24(6):751-759. doi: 10.1080/10903127.2020.1721740. Epub 2020 Mar 3.
PubMed 31985326Camaro C, Aarts GWA, Adang EMM, van Hout R, Brok G, Hoare A, Rodwell L, de Pooter F, de Wit W, Cramer GE, van Kimmenade RRJ, Damman P, Ouwendijk E, Rutten M, Zegers E, van Geuns RM, Gomes MER, van Royen N. Rule-out of non-ST-segment elevation acute coronary syndrome by a single, pre-hospital troponin measurement: a randomized trial. Eur Heart J. 2023 May 14;44(19):1705-1714. doi: 10.1093/eurheartj/ehad056.
PubMed 36755110Pedersen CK, Stengaard C, Friesgaard K, Dodt KK, Sondergaard HM, Terkelsen CJ, Botker MT. Chest pain in the ambulance; prevalence, causes and outcome - a retrospective cohort study. Scand J Trauma Resusc Emerg Med. 2019 Aug 29;27(1):84. doi: 10.1186/s13049-019-0659-6.
PubMed 31464622