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

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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).

Locations
Other Locations
Brazil
Instituto do Coração HCFMUSP
RECRUITING
São Paulo
Contact Information
Primary
José León
aro@incor.usp.br
+55 (11) 2661-5795
Time Frame
Start Date: 2025-03-10
Estimated Completion Date: 2026-03
Participants
Target number of participants: 200
Treatments
Experimental: POC Group
For patients randomized to the POC group, the Siemens Atellica VTLi kit will be used. This hs-cTnI test employs a two-site sandwich immunoassay, where anti-cTnI antibodies conjugated to paramagnetic particles bind to cTnI. The particles are manipulated by magnetic fields, allowing optical detection. The biomarker concentration is calculated using a calibration curve.~The primary sample is whole capillary blood, collected by fingertip puncture. Additionally, patients will have venous ultrasensitive troponin collected using the local laboratory.~Reference values (99th percentile, pg/mL): Women: 18.5 - Men: 27.1.~The cTnI values between 0 and LoD are reported as \<LoD; values above 1250 pg/mL as \>1250 pg/mL. Samples will be taken at times 0 and 1 hour. Analysis will follow the manufacturer's guidelines.
Placebo_comparator: Control Group
For patients randomized to the ultrasensitive troponin dosing arm using the local laboratory, the ABBOTT Alinity i kit will be used. Samples will be taken at 0 and 1 hour after admission. The sample for this analysis will be collected by venipuncture and should be drawn into serum tubes with a separator (5 mL capacity).~The Alinity i STAT High Sensitive Troponin-I assay is a chemiluminescence microparticle immunoassay (CMIA) for the quantitative determination of cardiac troponin I (cTnI) in serum and plasma using the Alinity i analyzer. The analysis will be conducted following the manufacturer's instructions. The measurement range of the assay is 10 to 50,000 pg/mL.~Population reference values (99th percentile, pg/mL):~Women (21-75 years): 15.6 Men (21-73 years): 34.2
Related Therapeutic Areas
Sponsors
Leads: University of Sao Paulo

This content was sourced from clinicaltrials.gov