Prehospital Point-of-Care Hs-Troponin I for Rule-Out of Acute Myocardial Infarction in Patients Without ST-Segment Elevation (Pre-POCT TnI)
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.
Přehled studie
Postavení
Detailní popis
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 studie
Zápis (Odhadovaný)
Kontakty a umístění
Studijní kontakt
- Jméno: Martin F Gude, MD, PhD
- Telefonní číslo: +45 25 34 36 21
- E-mail: martgude@rm.dk
Studijní záloha kontaktů
- Jméno: Arne SR Jensen, Paramedic
- Telefonní číslo: +45 22 39 69 68
- E-mail: arjens@rm.dk
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Metoda odběru vzorků
Studijní populace
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
|---|---|
|
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.
|
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.
Ostatní jména:
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Major adverse cardiac events (MACE) within 30 days
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Final diagnosis of acute coronary syndrome
Časové okno: 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
Časové okno: 30 days
|
Death from any cause within 30 days of the index emergency medical services contact.
|
30 days
|
|
Coronary revascularization within 30 days
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Successful prehospital blood sampling
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Martin F Gude, MD, PhD, Central Denmark Region
Publikace a užitečné odkazy
Obecné publikace
- 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.
- Camaro 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.
- Pedersen 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.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
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Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
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Termíny související s touto studií
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