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Prehospital Point-of-Care Hs-Troponin I for Rule-Out of Acute Myocardial Infarction in Patients Without ST-Segment Elevation (Pre-POCT TnI)

26 kwietnia 2026 zaktualizowane przez: Central Denmark Region

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.

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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Obserwacyjny

Zapisy (Szacowany)

500

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

  • Nazwa: Martin F Gude, MD, PhD
  • Numer telefonu: +45 25 34 36 21
  • E-mail: martgude@rm.dk

Kopia zapasowa kontaktu do badania

  • Nazwa: Arne SR Jensen, Paramedic
  • Numer telefonu: +45 22 39 69 68
  • E-mail: arjens@rm.dk

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Metoda próbkowania

Próbka prawdopodobieństwa

Badana populacja

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.

Opis

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Kohorty i interwencje

Grupa / Kohorta
Interwencja / Leczenie
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.
Test diagnostyczny: Prehospital high-sensitivity cardiac troponin I measurement
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.
Inne nazwy:
  • hs-TnI
  • Point-of-care troponin
  • i-STAT hs-TnI

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Major adverse cardiac events (MACE) within 30 days
Ramy czasowe: 30 days
Composite outcome including acute myocardial infarction, coronary revascularization, or cardiovascular death within 30 days of the index emergency medical services contact.
30 days

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Final diagnosis of acute coronary syndrome
Ramy czasowe: 24 hours
Final hospital diagnosis of acute coronary syndrome based on standard clinical evaluation, including serial cardiac troponin measurements and other diagnostic procedures as clinically indicated.
24 hours
All-cause 30-day mortality
Ramy czasowe: 30 days
Death from any cause within 30 days of the index emergency medical services contact.
30 days
Coronary revascularization within 30 days
Ramy czasowe: 30 days
Percutaneous coronary intervention or coronary artery bypass grafting performed within 30 days of the index emergency medical services contact.
30 days
Diagnostic performance of prehospital hs-TnI for acute coronary syndrome
Ramy czasowe: 24 hours
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.
24 hours
Diagnostic performance of prehospital hs-TnI for 30-day MACE
Ramy czasowe: 30 days
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.
30 days

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Successful prehospital blood sampling
Ramy czasowe: 24 hours
Proportion of eligible patients in whom a prehospital blood sample for high-sensitivity cardiac troponin I measurement is successfully obtained and analyzed.
24 hours
Valid hs-TnI measurement
Ramy czasowe: 24 hours
Proportion of prehospital high-sensitivity cardiac troponin I measurements yielding a valid result without device or cartridge error.
24 hours
Time to hs-TnI result
Ramy czasowe: 24 hours
Time from first EMS patient contact to availability of the prehospital high-sensitivity cardiac troponin I result.
24 hours
Agreement between prehospital and in-hospital hs-TnI measurements
Ramy czasowe: 24 hours
Agreement between prehospital point-of-care high-sensitivity cardiac troponin I (hs-TnI) measurements and in-hospital hs-TnI measurements performed on the same blood sample. This analysis is conducted in a subset of patients admitted directly to the Department of Cardiology, where blood samples obtained prehospitally are handed over at hospital admission for laboratory analysis. Agreement will be assessed using appropriate statistical methods (e.g., correlation and agreement analyses).
24 hours
Exploratory risk stratification based on prehospital hs-TnI concentrations and symptom onset timing
Ramy czasowe: 30 days

Exploratory classification of patients according to prehospital high-sensitivity cardiac troponin I (hs-TnI) concentrations in relation to time from symptom onset. Patients will be categorized into groups with: (1) low hs-TnI concentrations associated with low risk of acute coronary syndrome and major adverse cardiac events; (2) intermediate or moderately elevated hs-TnI concentrations representing a potential observation group, including patients with elevated hs-TnI concentrations who remain at low risk of acute coronary syndrome and major adverse cardiac events; and (3) higher hs-TnI concentrations associated with increased risk of acute coronary syndrome and major adverse cardiac events.

Analyses will explore the potential for serial prehospital hs-TnI measurements and the identification of patient groups with differing risk profiles. These analyses are descriptive and exploratory and are not used to guide clinical decision-making.
30 days

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Central Denmark Region

Śledczy

  • Główny śledczy: Martin F Gude, MD, PhD, Central Denmark Region

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

15 maja 2026

Zakończenie podstawowe (Szacowany)

14 maja 2027

Ukończenie studiów (Szacowany)

30 czerwca 2027

Daty rejestracji na studia

Pierwszy przesłany

26 kwietnia 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

26 kwietnia 2026

Pierwszy wysłany (Rzeczywisty)

4 maja 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

4 maja 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

26 kwietnia 2026

Ostatnia weryfikacja

1 kwietnia 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 1-10-72-8-26

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Opis planu IPD

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.

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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