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

NCT ID: NCT04950244

Last Updated: 2024-05-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

800 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-08-20

Study Completion Date

2023-11-16

Brief Summary

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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)

Detailed Description

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Conditions

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Chest Pain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Poitiers University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU Poitiers

Poitiers, , France

Site Status

Countries

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France

Provided Documents

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Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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VALIDATE

Identifier Type: -

Identifier Source: org_study_id

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