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Completed

NCT Number: NCT04950244

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Poitiers

Poitiers, 86000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High-sensitivity cardiac troponin I (hs-cTnI)

Diagnostic Test

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

Primary outcomes

  1. Clinical performance of hs-cTnI for rule-out of cardiac origin of chest pain in the out of hospital setting

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Poitiers University Hospital

Other

Registry information

Acronym: VALIDATE

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jul 6, 2021
Registry last updated
May 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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