Point-of-Care Troponin Testing in the Emergency Department
ConditionAcute Coronary Syndromes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorKU Leuven
About this trial
The goal of this study is to evaluate whether a POC-guided testing strategy to exclude non-ST elevation myocardial infarction (NSTEMI) in acute chest pain patients presenting at the emergency department (ED) can result in a shorter length of stay compared to the routine central laboratory testing strategy. Currently, most often two high-sensitivity troponin (hs-cTn) tests are required for exclusion of NSTEMI, and central laboratories are struggling to achieve the recommended turnaround time of 60 minutes. Novel POC hs-cTn testing technology can provide results in minutes, potentially reducing the ED length of stay. This may lead to a reduction in ED crowding, which is a growing worldwide healthcare problem, resulting in poorer patient outcomes. This study may therefore improve patient burden, ED staff workload, and lead to more efficient expenditure of healthcare resources.
We will perform a prospective, cross-sectional, interventional, single-center, open label, randomized trial.
All consecutive patients older than 18 years and younger than 75 years presenting at the UZ Leuven emergency department with chest pain or chest pain-equivalent symptoms suspected of an acute coronary syndrome (ACS) will be invited to participate in the study. After informed consent patients will be randomized into the point-of-care testing (POCT) group or the usual care group. Patients in the POCT group will undergo the novel POC test-guided strategy. In the POC strategy the first hs-cTnI test shortly after admission to the ED will be performed on the POC Atellica VTLi. The second test will be performed with the usual central laboratory hs-cTnT test. Patients in the usual care group will undergo the usual testing strategy with one or two hs-cTnT tests performed in the hospital's central laboratory.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures - At least 18 years of age at the time of signing the Informed Consent Form (ICF)
Age < 75 years of age
Presenting with chest pain or chest pain-equivalent symptom suspect of acute coronary syndrome at the University Hospitals Leuven emergency department; Symptoms must have (had) a minimum duration of 15 minutes, and the current, ongoing episode of symptoms must have started within the past 12 hours.
Disqualifiers
Unable to provide written informed consent
Age <18 years or >75 years
Chest pain or equivalent symptom with a duration shorter than 15 minutes, or an onset of the current, ongoing episode of symptoms more than 12 hours ago
Clinically unstable patients or confirmed STEMI patients, requiring immediate treatment
Trial design
Design model
Parallel
Treatments tested in this trial
Point-of-Care high-sensitivity troponin testing
DeviceTo establish in a randomized interventional controlled trial whether a novel POC test-guided strategy in acute chest pain patients in the ED results in a reduced length of stay compared to the usual central laboratory testing strategy when managing patients with a suspicion of NSTEMI
Treatment groups
1,552 Participants
are divided into 2 treatment groupsGroup A: Usual careNo intervention 0 interventions
Group B: InterventionActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Length of stay at emergency department
with a tracking bracelet we measure the time of presentation until discharge of the patient in the emergency department
Time frame
Hours: 24Secondary outcomes
1
30-day MACE
To assess the secondary endpoint of major adverse cardiac events (MACE), the final diagnosis after the ED visit will be extracted from the electronic hospital patient record. For patients discharged home from the ED, thirty days after discharge the patient's hospital record will be checked and the patient's regular GP will be contacted to confirm if any major adverse cardiac events occurred.
Time frame
Day: 30Other outcomes
1
Degree of user friendliness: questionnaires and qualitative think aloud sessions
user friendliness of the POC Atellica VTLi hs-cTnI test device: questionnaires and think aloud sessions for qualitative research
Time frame
Hours: 242
Phyisican adherence
The physician will be asked to indicate whether the proposed testing strategy was followed or whether he or she deviated from it and the reason why, to assess the physician adherence to the testing strategy.
Time frame
Hours: 243
Patient satisfaction
Patient satisfaction with the POC test-guided strategy will be assessed as an exploratory endpoint by contacting the patients after discharge (at day 7 baseline visit) and taking questionnaires on how they experienced their care. The Short Assessment of Patient Satisfaction (SAPS-)questionnaire will be used, extended with open questions and specific questions to our current study. Scoring is done by first reversing the scores for items #1, #3, #5, #7, and then summing all scores. The score range is from 0 (extremely dissatisfied) to 28 (extremely satisfied)
Time frame
Day: 74
Comparison of POC and central laboratory hs-cTnI testing, and central laboratory hs-cTnT testing
Congruence between POC and central laboratory hs-cTnI testing, and central laboratory hs-cTnT testing: assessment of agreement in terms of diagnostic accuracy and correlation
Time frame
Hours: 24Sponsors and contacts
Click on the lead sponsor to view all of their trials.
KU Leuven
Lead sponsor
Universitaire Ziekenhuizen KU Leuven
Collaborator
Source ClinicalTrials.gov