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

Not Applicable

Recruiting

• Conditions: Acute Coronary Syndromes (ACS); Troponin I; Point-of-Care Testing

• Registration Number: NCT06861582
• Lead Sponsor: University of Sao Paulo

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)

Study Timeline

• Study First Submitted: 2025-02-24
• Study First Submitted QC: 2025-02-28
• Study First Posted: 2025-03-06
• Study Start: 2025-03-10
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-07
• Last Update Posted: 2025-04-08
• Primary Completion: 2026-03
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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.
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
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.

Trial Locations

Locations (1)

Instituto do Coração HCFMUSP; 🇧🇷 São Paulo, Brazil