Prehospital Point-of-Care Hs-Troponin I for Rule-Out of Acute Myocardial Infarction in Patients Without ST-Segment Elevation

NCT07563998 | Not Yet Recruiting

• 1 other identifier: 1-10-72-8-26
• Study Type: observational
• Target: 500
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Myocardial Infarction (MI); Acute Coronary Syndromes (ACS)

Keywords

Prehospital; Emergency Medical Services; Point-of-Care Testing; POCT; High-Sensitivity Troponin I; Chest Pain; Non-ST Elevation; Diagnostic Accuracy; Risk Stratification; Major Adverse Cardiac Events; MACE

Outcome Measures

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.

  30 days

Secondary Outcomes (5)

• Final diagnosis of acute coronary syndrome

  24 hours

• All-cause 30-day mortality

  30 days

• Coronary revascularization within 30 days

  30 days

• Diagnostic performance of prehospital hs-TnI for acute coronary syndrome

  24 hours

• Diagnostic performance of prehospital hs-TnI for 30-day MACE

  30 days

Other Outcomes (5)

• Successful prehospital blood sampling

  24 hours

• Valid hs-TnI measurement

  24 hours

• Time to hs-TnI result

  24 hours

Study Arms (1)

Patients with suspected non-ST-segment elevation acute coronary syndrome (NSTE-ACS)

Adult patients assessed by participating emergency medical services (EMS) units with symptoms suggestive of acute coronary syndrome (ACS), in whom ST-segment elevation myocardial infarction (STEMI) is not identified on the prehospital electrocardiogram, and who are managed with planned transport to hospital for further evaluation. Patients undergo prehospital blood sampling for high-sensitivity cardiac troponin I (hs-TnI) measurement using a point-of-care device. Clinical management, triage, and transport decisions are not influenced by study participation or biomarker results.

Diagnostic Test: Prehospital high-sensitivity cardiac troponin I measurement

Interventions

Prehospital high-sensitivity cardiac troponin I measurement DIAGNOSTIC_TEST

Prehospital 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.

Also known as: hs-TnI, Point-of-care troponin, i-STAT hs-TnI

Patients with suspected non-ST-segment elevation acute coronary syndrome (NSTE-ACS)

Eligibility Criteria

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

Study 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.

You may qualify if:

• 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

You may not qualify if:

• ST-segment elevation on prehospital electrocardiogram
• Clinical condition requiring immediate life-saving intervention precluding study procedures
• Interhospital transport

Sponsors & Collaborators

• Central Denmark Region: lead

Related Publications (3)

• Stopyra JP, Snavely AC, Scheidler JF, Smith LM, Nelson RD, Winslow JE, Pomper GJ, Ashburn NP, Hendley NW, Riley RF, Koehler LE, Miller CD, Mahler SA. Point-of-Care Troponin Testing during Ambulance Transport to Detect Acute Myocardial Infarction. Prehosp Emerg Care. 2020 Nov-Dec;24(6):751-759. doi: 10.1080/10903127.2020.1721740. Epub 2020 Mar 3.

  PMID: 31985326 BACKGROUND

• Camaro C, Aarts GWA, Adang EMM, van Hout R, Brok G, Hoare A, Rodwell L, de Pooter F, de Wit W, Cramer GE, van Kimmenade RRJ, Damman P, Ouwendijk E, Rutten M, Zegers E, van Geuns RM, Gomes MER, van Royen N. Rule-out of non-ST-segment elevation acute coronary syndrome by a single, pre-hospital troponin measurement: a randomized trial. Eur Heart J. 2023 May 14;44(19):1705-1714. doi: 10.1093/eurheartj/ehad056.

  PMID: 36755110 BACKGROUND

• Pedersen CK, Stengaard C, Friesgaard K, Dodt KK, Sondergaard HM, Terkelsen CJ, Botker MT. Chest pain in the ambulance; prevalence, causes and outcome - a retrospective cohort study. Scand J Trauma Resusc Emerg Med. 2019 Aug 29;27(1):84. doi: 10.1186/s13049-019-0659-6.

  PMID: 31464622 BACKGROUND

MeSH Terms

Conditions

Myocardial Infarction; Acute Coronary Syndrome; Chest Pain; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Martin F Gude, MD, PhD

  Central Denmark Region

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Martin F Gude, MD, PhD

CONTACT

+45 25 34 36 21; martgude@rm.dk

Arne SR Jensen, Paramedic

CONTACT

+45 22 39 69 68; arjens@rm.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2026
• First Posted: May 4, 2026
• Study Start (Estimated): May 15, 2026
• Primary Completion (Estimated): May 14, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share