NCT04950244

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 800 (actual)
• Sponsor: Poitiers University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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)

Conditions

• Chest Pain

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-08-20
• Primary completion: 2023-10-16
• Completion: 2023-11-16
• First posted: 2021-07-06
• Last updated: 2024-05-01

Locations

1 site across 1 country: France