Diagnostic Evaluation of Out-of-hospital High-sensitivity Troponin I in Patients Presenting Chest Pain

Study Overview
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Brief Summary
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Conducting an analysis of the clinical performance of high-sensitivity cardiac troponin I, tested in the out-of-hospital setting, for ruling out cardiac origin in acute onset chest pain. Acute onset chest pain is a complex symptom to narrow down in the out-of-hospital setting. This is due to the difficulty of obtaining pertinent information over the phone, and the absence of validated dispatch scores or criteria. In France, the current standard of care relies on the rapid dispatch of Emergency Medical Response Teams along with a physician in patients presenting symptoms evocative of Coronary Artery Disease or Myocardial Infarction. Typical anginal pain includes retrosternal pressure pain radiating to the jaw, neck, or left arm. Diagnostic work-up includes anamnesis, physical examination, routine blood work, and ECG. In the absence of signification ST-segment modifications, the gold standard relies on trending serum Troponin T and I in the hospital setting . This study aims to analyze the clinical performance of high-sensitivity cardiac Troponin I assays (hs-cTnI) in the out-of-hospital setting using a point-of-care device ; Atellica VTLi (Siemens Healthineers)

Official Title
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Diagnostic Evaluation of Out-of-hospital High-sensitivity Troponin I in Patients Presenting Chest Pain

Conditions
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Chest Pain

Intervention / Treatment
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* Diagnostic Test: High-sensitivity cardiac troponin I (hs-cTnI)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Over 18 years of age Presenting with evocative acute onset chest pain Exclusion Criteria: ECG modifications with ST segment elevations Patients for whom anginal origin was excluded in the out-of-hospital setting Medical evaluation in a delay inferior to 20 minutes Patients without medical insurance Pregnant or lactating women Patients under reinforced guardianship, minors, patients in hospice care

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: High-sensitivity cardiac troponin I (hs-cTnI)|Capillary and veinous whole blood sampling for hs-cTnI was collected. The sample was tested at the bedside with a point-of-care device (Atellica VTLi, Siemens Healthineers). The result of both hs-c TnI values obtained was blinded to the treating physician|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical performance of hs-cTnI for rule-out of cardiac origin of chest pain in the out of hospital setting | Determining the more appropriate cut off in terms of specificity and sensitivity to rule out chest pain in relation to coronary artery disease, based on the ROC curve. | 3 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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High-sensitivity cardiac Troponin I, Troponin I HS