Acute Coronary Syndromes (ACS), Point-of-Care Testing, Troponin I
Conditions
Keywords
Acute Coronary Syndrome, Non-ST Elevation Myocardial Infarction, Troponin I, Point-of-Care Testing, Biomarkers, Emergency Service, Hospital, Myocardial Ischemia, Cardiovascular Diseases, Hospital Length of Stay
Brief 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.
Detailed description
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)
Interventions
DIAGNOSTIC_TESTPoint-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_TESTLaboratory-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
University of Sao Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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).
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 30 days | From emergency department admission to hospital discharge, assessed up to 30 days, depending on clinical evolution and treatment approach. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Determine the time to hospital discharge for patients where ACS has been ruled out (normal hs troponin values) | 24 hours | From emergency department admission to hospital discharge for patients with normal high-sensitivity troponin (hs-cTn) values, assessed up to 24 hours. |
| Comparing major adverse cardiovascular events (MACE) | 30 days | From emergency department admission to the occurrence of major adverse cardiovascular events (MACE) during hospitalization, assessed up to 30 days |
| Differences in ultrasensitive troponin values obtained by the two methods | At the time of randomization (0-hour) and at 1 hour | 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. |
| Compare the time between blood collection and the result for both groups | 4 hours | The times at which results become available after each blood sample collection will be assessed, up to 4 hours post-collection. |
| Comparison of the cost-effectiveness of the two diagnostic methods for ultrasensitive troponin measurement | 30 days | 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. |
| Differences between time from admission to diagnosis of NSTE ACS | 30 days | From emergency department admission to hospital discharge, assessed up to 30 days, depending on clinical evolution and treatment approach. |
Countries
Brazil
Contacts
Primary ContactJosé León
Outcome results
None listed