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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)

31 août 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Observationnel

Inscription (Estimé)

500

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

  • Nom: Martin F Gude, MD, PhD
  • Numéro de téléphone: +45 25 34 36 21
  • E-mail: martgude@rm.dk

Sauvegarde des contacts de l'étude

  • Nom: Arne SR Jensen, Paramedic
  • Numéro de téléphone: +45 22 39 69 68
  • E-mail: arjens@rm.dk

Lieux d'étude

  • Danemark
      • Aarhus N, Danemark, 8200
        • Recrutement
        • Prehospital Emergency Medical Services, Central Denamrk Region

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

Méthode d'échantillonnage

Échantillon de probabilité

Population étudiée

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.

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
Intervention / Traitement
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 diagnostique: 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.
Autres noms:
  • hs-TnI
  • Point-of-care troponin
  • i-STAT hs-TnI

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Major adverse cardiac events (MACE) within 30 days
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Final diagnosis of acute coronary syndrome
Délai: 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
Délai: 30 days
Death from any cause within 30 days of the index emergency medical services contact.
30 days
Coronary revascularization within 30 days
Délai: 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
Délai: 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
Délai: 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

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Successful prehospital blood sampling
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Central Denmark Region

Les enquêteurs

  • Chercheur principal: Martin F Gude, MD, PhD, Central Denmark Region

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 juillet 2026

Achèvement primaire (Estimé)

14 mai 2027

Achèvement de l'étude (Estimé)

30 juin 2027

Dates d'inscription aux études

Première soumission

26 avril 2026

Première soumission répondant aux critères de contrôle qualité

26 avril 2026

Première publication (Réel)

4 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

2 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

31 août 2026

Dernière vérification

1 août 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 1-10-72-8-26

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime 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.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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