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.
Objective: evaluation of the length of hospital stays for patients with chest pain in the Emergency Unit of the Heart Institute-HCFMUSP, comparing two methods of ultrasensitive troponin I dosage: the Atellica VTLi kit from Siemens, used in the point of care methodology, and the Alinity i kit from ABBOTT, used in the local laboratory. The aim is to compare the time elapsed between admission and discharge in the two groups, seeking to identify possible differences in the efficiency and speed of care provided by each method. Background: cardiovascular diseases (CVD) continue to be the main cause of mortality and morbidity in patients admitted to the emergency room with chest pain. Among CVDs, ischemic heart disease is the most lethal, accounting for 38% of all CVD deaths in women and 44% in men. Diagnosis in these cases must be rapid and efficient, since the prognosis improves significantly when treatment is started early in patients with ACS. Study design: randomized, open, comparative and parallel study at a single center. Sample size: 200 patients Intervention: eligible patients will be randomized 1:1 into two groups: the POC dosage group and the control group. In both groups, samples will be taken at time zero and after 1 hour. Primary outcome: Time between admission of a patient with chest pain symptoms to the emergency department of the Heart Institute-HCFMUSP and discharge after diagnosis of Non-ST Elevation Acute Coronary Syndrome (NSTE-ACS)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
200
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.
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.
Instituto do Coração HCFMUSP
São Paulo, Brazil
RECRUITINGTime 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.
Time frame: 30 days
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.
Time frame: At the time of randomization (0-hour) and at 1 hour
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.
Time frame: 30 days
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.
Time frame: 4 hours
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.
Time frame: 24 hours
Comparing major adverse cardiovascular events (MACE)
From emergency department admission to the occurrence of major adverse cardiovascular events (MACE) during hospitalization, assessed up to 30 days
Time frame: 30 days
Comparison of the cost-effectiveness of the two diagnostic methods for ultrasensitive troponin measurement
The cost-effectiveness of the two diagnostic methods will be assessed in US dollars using the Brazilian Public Health database. This database includes standardized costs for procedures, medications, and hospital stays, allowing for a comparative economic evaluation between point-of-care and laboratory-based ultrasensitive troponin testing.
Time frame: 30 days
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