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

Completed

• Conditions: Chest Pain

• Registration Number: NCT04950244
• Lead Sponsor: Poitiers University Hospital

Brief 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)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-22
• Study First Submitted QC: 2021-07-02
• Study First Posted: 2021-07-06
• Study Start: 2021-08-20
• Status Verified: 2023-01
• Primary Completion: 2023-10-16
• Study Completion: 2023-11-16
• Last Update Submitted: 2024-04-29
• Last Update Posted: 2024-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 800

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical performance of hs-cTnI for rule-out of cardiac origin of chest pain in the out of hospital setting	3 hours	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.

Trial Locations

Locations (1)

CHU Poitiers; 🇫🇷 Poitiers, France