Comparing Point-of-Care and Laboratory Ultrasensitive Troponin I Testing to Reduce Hospital Stay Length in Patients With Chest Pain
Led by University of Sao Paulo · Updated on 2025-04-08
200
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are comparing two methods for measuring high-sensitivity troponin I, a key marker used to diagnose heart attacks, in patients arriving at the emergency room with chest pain symptoms suggestive of Acute Coronary Syndrome ACS. The study aims to find out if using the Atellica VTLi kit from Siemens for point-of-care testing can reduce the time from hospital admission to discharge compared to the traditional laboratory method using the Alinity i kit from ABBOTT. This randomized, open, parallel study involves 200 patients and is conducted at a single center.
Participants will be randomly assigned to one of two groups. The point-of-care group will have whole capillary blood collected by fingertip puncture and tested rapidly using the Siemens Atellica VTLi kit, which provides results in about 8 minutes. The control group will have blood drawn by venipuncture and tested with the ABBOTT Alinity i kit in the laboratory. Both groups will have samples taken at admission and one hour later. The study compares speed, accuracy, and cost-effectiveness of these two diagnostic methods.
During the study, participants will have blood samples collected and undergo serial troponin testing. Researchers will measure the time from hospital admission to discharge after diagnosis of Non-ST Elevation Acute Coronary Syndrome NSTE-ACS. They will also assess differences in troponin levels, timing of diagnosis, result turnaround time, hospital discharge times for ruled-out cases, major adverse cardiovascular events, and cost-effectiveness over 30 days. The study involves informed consent and continuous monitoring during hospital stay and follow-up periods.
CONDITIONS
Brief Title
Effect of Point-of-care Analysis of Ultrasensitive Troponin I on Length of Hospital Stay in Patients With Cardiac Chest Pain (POC Troponina)
Research Team
J
José León
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Patients arriving in the emergency room with symptoms suggesting Acute Coronary Syndrome
Onset of chest pain between 3 and 12 hours after arrival
Planned serial troponin testing for investigation
Signed informed consent form
You will not qualify if you...
Patients with ST-segment elevation on ECG at hospital arrival
Conditions interfering with troponin test interpretation, including chronic renal failure, cancer, chronic lung diseases
Pregnant or breastfeeding patients
Patients already enrolled in other clinical research studies
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - Up to 1 hour
Participants undergo point-of-care or laboratory-based ultrasensitive troponin testing to diagnose Acute Coronary Syndrome. Blood samples are collected at admission and after 1 hour to assess cardiac troponin levels.
1 to 2 visits depending on blood collection times
Monitoring
Duration - Up to 30 days
Participants are observed from admission until discharge to evaluate the length of hospital stay and clinical outcomes following diagnosis.
Continuous monitoring during hospital stay, with discharge occurring based on diagnosis
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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Published Research Related To This Trial
National Academy of Clinical Biochemistry Laboratory Medicine Practice Guidelines: Clinical characteristics and utilization of biochemical markers in acute coronary syndromes.
David A Morrow, Christopher P Cannon, Robert L Jesse...
2021 AHA/ACC/ASE/CHEST/SAEM/SCCT/SCMR Guideline for the Evaluation and Diagnosis of Chest Pain: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines.
Martha Gulati, Phillip D Levy, Debabrata Mukherjee...
A 2-h diagnostic protocol to assess patients with chest pain symptoms in the Asia-Pacific region (ASPECT): a prospective observational validation study.
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.
Writing Committee, Michael C Kontos, James A de Lemos...