Effect of Point-of-care Analysis of Ultrasensitive Troponin I on Length of Hospital Stay in Patients With Cardiac Chest Pain (POC Troponina)

Summary

This clinical study aims to compare two different methods for measuring high-sensitivity troponin I, a key biomarker used to diagnose heart attacks.

The primary research question is: Does the use of the Atellica VTLi kit from Siemens for high-sensitivity troponin I (hs-cTnI) testing at the point of care (POC) significantly reduce the average time from admission to hospital discharge compared to the conventional laboratory methodology using the Alinity i kit from ABBOTT?

Participant will:

* Patients aged ≥ 18 years.
* Patients arriving in the emergency room with symptoms suggestive of ACS, with onset of pain between 3 and 12 hours after arrival, in whom serial troponin dosing is planned for investigation.
* Signature of the Informed Consent Form (ICF).

Researchers will analyze whether the point-of-care testing method helps speed up the hospital discharge process compared to the standard laboratory approach. They will also compare the accuracy of the test results, the time taken for clinical decisions, and the overall cost-effectiveness of the two methods.

Conditions

• Acute Coronary Syndromes (ACS)
• Troponin I
• Point-of-Care Testing

Interventions

DIAGNOSTIC_TEST

Point-of-care ultrasensitive troponin testing

For patients randomized to the ultrasensitive troponin dosing arm using point-of-care (POC) technology, the Atellica® VTLi Patient-side Immunoassay Analyzer (Siemens Healthineers) will be used. This high-sensitivity troponin I (hs-cTnI) test utilizes Magnotech® Technology with paramagnetic particles and external magnetic fields, providing rapid results (\~8 minutes) using whole capillary blood collected via fingertip puncture, and/or with direct withdrawal from the test tube. Additionally, venous blood samples will be collected for laboratory comparison. The assay measures hs-cTnI within a range of 0-1250 pg/mL, with values \<LoD and \>1250 pg/mL recorded accordingly. Samples will be collected at 0 and 1 hour. Reference values (99th percentile, pg/mL): Women: 18.5, Men: 27.1. This intervention enables bedside testing, reducing turnaround time compared to standard laboratory assays, facilitating early myocardial infarction diagnosis.

DIAGNOSTIC_TEST

Laboratory-based ultrasensitive troponin testing

For patients randomized to the ultrasensitive troponin dosing arm using the local laboratory, the Alinity™ i STAT High Sensitive Troponin-I assay (Abbott) will be used. Samples will be taken at 0 and 1 hour after admission by venipuncture and collected in 5 mL serum tubes with a separator. This chemiluminescence microparticle immunoassay (CMIA) quantifies cardiac troponin I (cTnI) in serum and plasma using the Alinity™ i analyzer, with a measurement range of 10-50,000 pg/mL. Analysis will follow the manufacturer's instructions. Reference values (99th percentile, pg/mL): Women (21-75 years): 15.6, Men (21-73 years): 34.2.

Sponsors & Collaborators

• University of Sao Paulo

  lead OTHER

Principal Investigators

• Ludhmila A Hajjar, Professor · University of Sao Paulo

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-03-10

Primary Completion

2026-03-31

Completion

2026-03-31

Countries

• Brazil

Study Locations