Diagnostic Evaluation of Out-of-hospital High-sensitivity Troponin I in Patients Presenting Chest Pain
NCT ID: NCT04950244
Last Updated: 2024-05-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
800 participants
OBSERVATIONAL
2021-08-20
2023-11-16
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* Presenting with evocative acute onset chest pain
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Poitiers University Hospital
OTHER
Responsible Party
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Locations
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CHU Poitiers
Poitiers, , France
Countries
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Provided Documents
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Document Type: Statistical Analysis Plan
Other Identifiers
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VALIDATE
Identifier Type: -
Identifier Source: org_study_id
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