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

P

Poitiers University Hospital

Status

Completed

Conditions

Chest Pain

Treatments

Diagnostic Test: High-sensitivity cardiac troponin I (hs-cTnI)

Study type

Observational

Funder types

Other

Identifiers

NCT04950244
VALIDATE

Details and patient eligibility

About

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)

Enrollment

800 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Jérémy GUENEZAN, Hospital Practitioner; Sabrina SEGUIN, CRA

Data sourced from clinicaltrials.gov

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