Completed

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

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What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Chest Pain+2

+ Neurologic Manifestations

+ Pain

Over 18 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: August 2021
See protocol details

Summary

Principal SponsorPoitiers University Hospital
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: August 20, 2021

Actual date on which the first participant was enrolled.

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)

Official TitleDiagnostic Evaluation of Out-of-hospital High-sensitivity Troponin I in Patients Presenting Chest Pain
NCT04950244
Principal SponsorPoitiers University Hospital
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

800 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Chest PainNeurologic ManifestationsPainSigns and SymptomsPathological Conditions, Signs and Symptoms

Criteria

2 inclusion criteria required to participate
Over 18 years of age

Presenting with evocative acute onset chest pain

6 exclusion criteria prevent from participating
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

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

CHU Poitiers

Poitiers, FranceOpen CHU Poitiers in Google Maps
CompletedOne Study Center