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

Chest Pain Clinical Trial

— VALIDATE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04950244
• Other study ID #: VALIDATE
• Status: Completed
• Start date: August 20, 2021
• Est. completion date: November 16, 2023

Study information

• Verified date: January 2023
• Source: Poitiers University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 800
• Est. completion date: November 16, 2023
• Est. primary completion date: October 16, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chest Pain
• Hypersensitivity

Intervention

Diagnostic Test:
• 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

Locations

Country	Name	City	State
France	CHU Poitiers	Poitiers

Sponsors (1)

Lead Sponsor	Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical performance of hs-cTnI for rule-out of cardiac origin of chest pain in the out of hospital setting	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.	3 hours