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

NCT04950244 | Completed

• 1 other identifier: VALIDATE
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

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)

Conditions

Chest Pain

Keywords

High-sensitivity cardiac Troponin I; Troponin I HS

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

overall population of callers to the emergency dispatch center

You may qualify if:

• Over 18 years of age
• Presenting with evocative acute onset chest pain

You may not qualify if:

• 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

Sponsors & Collaborators

• Poitiers University Hospital: lead

Study Sites (1)

CHU Poitiers

Poitiers, 86000, France

Location

MeSH Terms

Conditions

Chest Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2021
• First Posted: July 6, 2021
• Study Start: August 20, 2021
• Primary Completion: October 16, 2023
• Study Completion: November 16, 2023
• Last Updated: May 1, 2024

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)