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

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)

Study Overview

• Status: Completed
• Conditions: Chest Pain
• Intervention / Treatment: Diagnostic test: High-sensitivity cardiac troponin I (hs-cTnI)

• Study Type: Observational
• Enrollment (Actual): 800

Contacts and Locations

Study Locations

• France
  • Poitiers, France, 86000
    • CHU Poitiers

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

overall population of callers to the emergency dispatch center

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Poitiers University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2021
• Primary Completion (Actual): October 16, 2023
• Study Completion (Actual): November 16, 2023

Study Registration Dates

• First Submitted: June 22, 2021
• First Submitted That Met QC Criteria: July 2, 2021
• First Posted (Actual): July 6, 2021

Study Record Updates

• Last Update Posted (Actual): May 1, 2024
• Last Update Submitted That Met QC Criteria: April 29, 2024
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: High-sensitivity cardiac Troponin I; Troponin I HS
• Additional Relevant MeSH Terms: Immune System Diseases; Pain; Neurologic Manifestations; Hypersensitivity; Chest Pain
• Other Study ID Numbers: Validate

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No