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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04950244
Acronym
VALIDATE
Enrollment
800
Registered
2021-07-06
Start date
2021-08-20
Completion date
2023-11-16
Last updated
2024-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chest Pain

Keywords

High-sensitivity cardiac Troponin I, Troponin I HS

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)

Interventions

DIAGNOSTIC_TESTHigh-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

Sponsors

Poitiers University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Clinical performance of hs-cTnI for rule-out of cardiac origin of chest pain in the out of hospital setting3 hoursDetermining 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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 27, 2026