Clinical trial NCT06861582: Effect of Point-of-care Analysis of Ultrasensitive Troponin I on Length of Hospital Stay in Patients With Cardiac Chest Pain (POC Troponina)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Coronary Syndromes (ACS)
Troponin I
Point-of-Care Testing
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
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2025-03-06
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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)

Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: 30 days
Secondary outcomes:
measure: Differences in ultrasensitive troponin values obtained by the two methods
timeFrame: At the time of randomization (0-hour) and at 1 hour
measure: Differences between time from admission to diagnosis of NSTE ACS
timeFrame: 30 days
measure: Compare the time between blood collection and the result for both groups
timeFrame: 4 hours
measure: Determine the time to hospital discharge for patients where ACS has been ruled out (normal hs troponin values)
timeFrame: 24 hours
measure: Comparing major adverse cardiovascular events (MACE)
timeFrame: 30 days
measure: Comparison of the cost-effectiveness of the two diagnostic methods for ultrasensitive troponin measurement
timeFrame: 30 days
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Instituto do Coração HCFMUSP
Study officials:
affiliation: University of Sao Paulo
name: Ludhmila A Hajjar, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Leonel T, Ferreira C, Braz R, Paladino F, Silva H, Gomes S, et al. Clinical and Laboratory Validation of the Atellica vTLi Analyzer for Diagnosis of Myocardial Infarction through High Sensitivity Cardiac Troponin I (hs-cTnI) Measurement. In 2024.
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