VALIDATE: Diagnostic Evaluation of Out-of-hospital High-sensitivity Troponin I in Patients Presenting Chest Pain
Study Details
Study Description
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)
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Study Design
Outcome Measures
Primary Outcome Measures
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Over 18 years of age
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Presenting with evocative acute onset chest pain
Exclusion Criteria:
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ECG modifications with ST segment elevations
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Patients for whom anginal origin was excluded in the out-of-hospital setting
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Medical evaluation in a delay inferior to 20 minutes
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Patients without medical insurance
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Pregnant or lactating women
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Patients under reinforced guardianship, minors, patients in hospice care
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CHU Poitiers | Poitiers | France | 86000 |
Sponsors and Collaborators
- Poitiers University Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- VALIDATE