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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Диагностический тест 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.

Первичные конечные точки

• Major adverse cardiac events (MACE) within 30 days [Срок оценки: 30 days]

Вторичные конечные точки (5)

• Final diagnosis of acute coronary syndrome [Срок оценки: 24 hours]
• All-cause 30-day mortality [Срок оценки: 30 days]
• Coronary revascularization within 30 days [Срок оценки: 30 days]
• Diagnostic performance of prehospital hs-TnI for acute coronary syndrome [Срок оценки: 24 hours]
• Diagnostic performance of prehospital hs-TnI for 30-day MACE [Срок оценки: 30 days]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• 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. PMID 31985326
• 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 PMID 36755110
• 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. PMID 31464622

Идентификаторы

NCT: NCT07563998 · 1-10-72-8-26

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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