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.
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).
Patients presenting with ACS with ST-segment elevation on the 12-lead ECG on arrival at hospital.
Patients with conditions that interfere with the interpretation of troponin dosage (chronic renal failure, cancer, chronic lung diseases).
Pregnant or breastfeeding patients.
Patients already included in other clinical research protocols.
Parallel
Point-of-care ultrasensitive troponin testing
Diagnostic testFor 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.
Laboratory-based ultrasensitive troponin testing
Diagnostic testFor 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.
Time between admission of a patient with chest pain symptoms to the emergency department of the Heart Institute-HCFMUSP and discharge after diagnosis of ACS-NSTE.
From emergency department admission to hospital discharge, assessed up to 30 days, depending on clinical evolution and treatment approach.
Differences in ultrasensitive troponin values obtained by the two methods
The primary assessment of ultrasensitive troponin values will occur from the first blood sample collection (0-hour) to the second collection (1-hour). Additional blood samples may be collected if clinically indicated, but only within the hospitalization period.
Differences between time from admission to diagnosis of NSTE ACS
From emergency department admission to hospital discharge, assessed up to 30 days, depending on clinical evolution and treatment approach.
Compare the time between blood collection and the result for both groups
The times at which results become available after each blood sample collection will be assessed, up to 4 hours post-collection.
Determine the time to hospital discharge for patients where ACS has been ruled out (normal hs troponin values)
From emergency department admission to hospital discharge for patients with normal high-sensitivity troponin (hs-cTn) values, assessed up to 24 hours.
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