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

April 7, 2025 updated by: Ludhmila Abrahão Hajjar MD, PhD, University of Sao Paulo

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)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Brazil
      • São Paulo, Brazil, 05403-000
        • Recruiting
        • Instituto do Coração HCFMUSP
        • Principal Investigator:
          • Ludhmila Hajjar
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: POC Group

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
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 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.
Other Names:
  • Atellica® VTLi Patient-side Immunoassay Analyzer
Placebo Comparator: Control Group

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
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.
Other Names:
  • Alinity™ i STAT High Sensitive Troponin-I assay

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 30 days
From emergency department admission to hospital discharge, assessed up to 30 days, depending on clinical evolution and treatment approach.
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Differences in ultrasensitive troponin values obtained by the two methods
Time Frame: 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.
At the time of randomization (0-hour) and at 1 hour
Differences between time from admission to diagnosis of NSTE ACS
Time Frame: 30 days
From emergency department admission to hospital discharge, assessed up to 30 days, depending on clinical evolution and treatment approach.
30 days
Compare the time between blood collection and the result for both groups
Time Frame: 4 hours
The times at which results become available after each blood sample collection will be assessed, up to 4 hours post-collection.
4 hours
Determine the time to hospital discharge for patients where ACS has been ruled out (normal hs troponin values)
Time Frame: 24 hours
From emergency department admission to hospital discharge for patients with normal high-sensitivity troponin (hs-cTn) values, assessed up to 24 hours.
24 hours
Comparing major adverse cardiovascular events (MACE)
Time Frame: 30 days
From emergency department admission to the occurrence of major adverse cardiovascular events (MACE) during hospitalization, assessed up to 30 days
30 days
Comparison of the cost-effectiveness of the two diagnostic methods for ultrasensitive troponin measurement
Time Frame: 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.
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Investigators

  • Principal Investigator: Ludhmila A Hajjar, Professor, University of São Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 10, 2025

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

March 1, 2026

Study Registration Dates

First Submitted

February 24, 2025

First Submitted That Met QC Criteria

February 28, 2025

First Posted (Actual)

March 6, 2025

Study Record Updates

Last Update Posted (Actual)

April 8, 2025

Last Update Submitted That Met QC Criteria

April 7, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 83553824.1.0000.0068

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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