Prehospital Point-of-Care Hs-Troponin I for Rule-Out of Acute Myocardial Infarction in Patients Without ST-Segment Elevation
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCentral Denmark Region
About this trial
People who call emergency medical services (EMS) with chest pain or other possible heart-related symptoms are often taken to hospital for further testing. However, only a small proportion of these patients are ultimately diagnosed with a serious heart condition such as a heart attack. This means that many patients undergo hospital transport and evaluation even though their risk is low.
In hospitals, a blood test called high-sensitivity cardiac troponin is commonly used to help diagnose or rule out heart attacks. It is not yet well established whether this type of test can be used safely and effectively earlier, in the prehospital setting.
This study will investigate whether it is feasible to measure high-sensitivity troponin in the ambulance and how well the test can identify patients at low risk of serious heart conditions. A small blood sample will be taken as part of routine care and analyzed using a portable device. The test result will not be used to guide treatment or decisions during the study.
The study will assess how well the test predicts heart-related events within 30 days and how practical it is to perform the test in real-life emergency settings. The results may help guide future research on how to improve early assessment and decision-making for patients with suspected heart disease.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 years or older
Assessed by one of the participating EMS units equipped for POCT sampling
Presentation with symptoms suggestive of acute coronary syndrome
Planned transport to hospital for further evaluation
Disqualifiers
ST-segment elevation on prehospital electrocardiogram
Clinical condition requiring immediate life-saving intervention precluding study procedures
Interhospital transport
Prior inclusion in the study within 30 days
Trial population
Patients are recruited from the prehospital emergency medical services (EMS) system in the Central Denmark Region, Denmark. Participants are identified during routine ambulance missions by EMS personnel in units equipped with point-of-care testing (POCT) devices and trained in study procedures. The study population reflects real-world prehospital patients encountered in a publicly funded, tax-supported healthcare system with universal access to emergency care. Patients are included consecutively during the study period based on operational availability of participating EMS units.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Prehospital high-sensitivity cardiac troponin I measurement
Diagnostic testPrehospital measurement of high-sensitivity cardiac troponin I (hs-TnI) using a point-of-care device during routine emergency medical services (EMS) assessment. Blood samples are analyzed according to manufacturer instructions and local procedures. The test is performed for research purposes only, and results are not available for clinical decision-making and do not influence patient management.
Treatment groups
500 Participants
are divided into 1 treatment groupGroup A: Patients with suspected non-ST-segment elevation acute coronary syndrome (NSTE-ACS)1 intervention
Trial outcomes
Primary outcomes
1
Major adverse cardiac events (MACE) within 30 days
Composite outcome including acute myocardial infarction, coronary revascularization, or cardiovascular death within 30 days of the index emergency medical services contact.
Time frame
30 daysSecondary outcomes
1
Final diagnosis of acute coronary syndrome
Final hospital diagnosis of acute coronary syndrome based on standard clinical evaluation, including serial cardiac troponin measurements and other diagnostic procedures as clinically indicated.
Time frame
24 hours2
All-cause 30-day mortality
Death from any cause within 30 days of the index emergency medical services contact.
Time frame
30 days3
Coronary revascularization within 30 days
Percutaneous coronary intervention or coronary artery bypass grafting performed within 30 days of the index emergency medical services contact.
Time frame
30 days4
Diagnostic performance of prehospital hs-TnI for acute coronary syndrome
Diagnostic performance of prehospital high-sensitivity cardiac troponin I for identifying acute coronary syndrome, reported as sensitivity, specificity, positive and negative predictive values, likelihood ratios, and area under the receiver operating characteristic curve.
Time frame
24 hoursOther outcomes
1
Successful prehospital blood sampling
Proportion of eligible patients in whom a prehospital blood sample for high-sensitivity cardiac troponin I measurement is successfully obtained and analyzed.
Time frame
24 hours2
Valid hs-TnI measurement
Proportion of prehospital high-sensitivity cardiac troponin I measurements yielding a valid result without device or cartridge error.
Time frame
24 hours3
Time to hs-TnI result
Time from first EMS patient contact to availability of the prehospital high-sensitivity cardiac troponin I result.
Time frame
24 hours4
Agreement between prehospital and in-hospital hs-TnI measurements
Agreement between prehospital point-of-care high-sensitivity cardiac troponin I (hs-TnI) measurements and in-hospital hs-TnI measurements performed on the same blood sample. This analysis is conducted in a subset of patients admitted directly to the Department of Cardiology, where blood samples obtained prehospitally are handed over at hospital admission for laboratory analysis. Agreement will be assessed using appropriate statistical methods (e.g., correlation and agreement analyses).
Time frame
24 hoursSponsors and contacts
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Source ClinicalTrials.gov