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

NCT06861582 | Recruiting

• 1 other identifier: 83553824.1.0000.0068
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  30 days

Secondary Outcomes (6)

• Differences in ultrasensitive troponin values obtained by the two methods

  At the time of randomization (0-hour) and at 1 hour

• Differences between time from admission to diagnosis of NSTE ACS

  30 days

• Compare the time between blood collection and the result for both groups

  4 hours

• Determine the time to hospital discharge for patients where ACS has been ruled out (normal hs troponin values)

  24 hours

• Comparing major adverse cardiovascular events (MACE)

  30 days

Study Arms (2)

POC Group

EXPERIMENTAL

For patients randomized to the POC group, the Siemens Atellica VTLi kit will be used. This hs-cTnI test employs a two-site sandwich immunoassay, where anti-cTnI antibodies conjugated to paramagnetic particles bind to cTnI. The particles are manipulated by magnetic fields, allowing optical detection. The biomarker concentration is calculated using a calibration curve. The primary sample is whole capillary blood, collected by fingertip puncture. Additionally, patients will have venous ultrasensitive troponin collected using the local laboratory. Reference values (99th percentile, pg/mL): Women: 18.5 - Men: 27.1. The cTnI values between 0 and LoD are reported as \<LoD; values above 1250 pg/mL as \>1250 pg/mL. Samples will be taken at times 0 and 1 hour. Analysis will follow the manufacturer's guidelines.

Diagnostic Test: Point-of-care ultrasensitive troponin testing

Control Group

PLACEBO COMPARATOR

For patients randomized to the ultrasensitive troponin dosing arm using the local laboratory, the ABBOTT Alinity i kit will be used. Samples will be taken at 0 and 1 hour after admission. The sample for this analysis will be collected by venipuncture and should be drawn into serum tubes with a separator (5 mL capacity). The Alinity i STAT High Sensitive Troponin-I assay is a chemiluminescence microparticle immunoassay (CMIA) for the quantitative determination of cardiac troponin I (cTnI) in serum and plasma using the Alinity i analyzer. The analysis will be conducted following the manufacturer's instructions. The measurement range of the assay is 10 to 50,000 pg/mL. Population reference values (99th percentile, pg/mL): Women (21-75 years): 15.6 Men (21-73 years): 34.2

Diagnostic Test: Laboratory-based ultrasensitive troponin testing

Interventions

Point-of-care ultrasensitive troponin testing DIAGNOSTIC_TEST

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.

Also known as: Atellica® VTLi Patient-side Immunoassay Analyzer

POC Group

Laboratory-based ultrasensitive troponin testing DIAGNOSTIC_TEST

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.

Also known as: Alinity™ i STAT High Sensitive Troponin-I assay

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Instituto do Coração HCFMUSP

São Paulo, 05403-000, Brazil

RECRUITING

Related Publications (14)

• 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.

  BACKGROUND

• Leonel T, Mix A, Vivanco P. Comparison of Performance of High Sensitive Troponin I (cTNIH) by Point-of-care (POC) and Automated cTNIH Immunoassays in Patients at Low Risk of Heart Attack in a Chilean Emergency Unit; Impact on Emergency Department Efficiency. In 2024

  BACKGROUND

• Gunsolus IL, Schulz K, Sandoval Y, Smith SW, Lindgren B, Okeson B, Apple FS. Diagnostic performance of a rapid, novel, whole blood, point of care high-sensitivity cardiac troponin I assay for myocardial infarction. Clin Biochem. 2022 Jul-Aug;105-106:70-74. doi: 10.1016/j.clinbiochem.2022.04.008. Epub 2022 Apr 18.

  PMID: 35447148 BACKGROUND

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• Writing Committee; Kontos MC, de Lemos JA, Deitelzweig SB, Diercks DB, Gore MO, Hess EP, McCarthy CP, McCord JK, Musey PI Jr, Villines TC, Wright LJ. 2022 ACC Expert Consensus Decision Pathway on the Evaluation and Disposition of Acute Chest Pain in the Emergency Department: A Report of the American College of Cardiology Solution Set Oversight Committee. J Am Coll Cardiol. 2022 Nov 15;80(20):1925-1960. doi: 10.1016/j.jacc.2022.08.750. Epub 2022 Oct 11. No abstract available.

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MeSH Terms

Conditions

Acute Coronary Syndrome; Non-ST Elevated Myocardial Infarction; Emergencies; Myocardial Ischemia; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Heart Diseases; Vascular Diseases; Myocardial Infarction; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Disease Attributes

Study Officials

• Ludhmila A Hajjar, Professor

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

José León

CONTACT

+55 (11) 2661-5795; aro@incor.usp.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor of Emergency Medicine

Study Record Dates

• First Submitted: February 24, 2025
• First Posted: March 6, 2025
• Study Start: March 10, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: April 8, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)