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Completed

NCT Number: NCT06051110

Individual Patient Data Meta-analysis on Prehospital Risk Assessment in Patients Suspected of Non-ST-segment Elevation Acute Coronary Syndrome

Patients with a non-ST-segment elevation acute coronary syndrome (NSTE-ACS) are currently transported and admitted to the nearest emergency department (ED) for risk stratification, diagnostic workup, and treatment. Recently, several prospective studies have been performed on the diagnostic performance of point-of-care (POC)-troponin and combined risk scores (CRS) for pre-hospital risk assessment and triage of NSTE-ACS patients. Also the first intervention trials on triage decisions based on POC troponin and CRS have been performed. Initial results are indicating that prehospital triage based on these diagnostic tools is feasible and safe, although sample sizes were relatively small and underpowered to detect differences in major adverse cardiac events (MACE). The objective of this individual patient data meta-analysis is to determine the diagnostic performance of POC troponin and combined risk scores for prehospital risk assessment and triage in suspected NSTE-ACS patients.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Catharina hospital Eindhoven

Eindhoven, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients suspected for NSTE-ACS;
  • Prospective study
  • Original data
  • Presenting prehospital (EMS)
  • Prehospital risk assessment using at least POC-troponin, performed and analyzed by EMS.
  • Outcome data available on in-hospital ACS or MACE within 30 days.

Exclusion criteria

  • Enrolling only a specific subpopulation from the general ACS population
  • Studies with less than 100 patients
  • Studies enrolling only patients with STEMI.
  • Studies published before 1995 / the pre-troponin era
  • Studies performed by general practitioners.

Treatment and study plan

Combined risk score

Device

Prehospital risk stratification by the use of a combined clinical risk score including POC-troponin

Usual Care

Other

Prehospital risk stratification by EMS protocols

point-of-care troponin

Device

Prehospital risk stratification by the use of a POC-troponin

Primary outcomes

  1. Number of participants with the diagnosis NSTE-ACS

    Time frame: During index hospitalization, up to 1 day in the ED

    Diagnosis of NSTE-ACS (NSTEMI or unstable AP) during index hospitalization (as assessed by the treating physician)

  2. MACE

    Time frame: Within 30 days

    All cause death, myocardial infarction, revascularization

Secondary outcomes

  1. MACE

    Time frame: 1 week

    All cause death, myocardial infarction, revascularization

  2. All cause death

    Time frame: Within 30 days and 1 year follow-up

  3. The number of participants undergoing invasive coronary angiography

    Time frame: During or after index hospitalisation, up to 30 days

  4. The number of participants undergoing coronary revascularisation

    Time frame: During or after index hospitalisation, up to 30 days

    percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG)

  5. Alternative diagnoses other than NSTE-ACS

    Time frame: during 30 day follow-up after inclusion

    If no NSTE-ACS is diagnosed, what is the alternative diagnosis (such as pulmonary embolism, aortic dissection, pneumothorax)

  6. Safety endpoints concerning intracoronary angiography and/or PCI

    Time frame: during 30 day follow-up after intracoronary angiography and/or PCI

    Bleeding complications

  7. Safety endpoints concerning intracoronary angiography and/or PCI

    Time frame: during 30 day follow-up after intracoronary angiography and/or PCI

    Contrast-induced nephropathy Possible or definite stent thrombosis Ischemic stroke Death

  8. Safety endpoints concerning intracoronary angiography and/or PCI

    Time frame: during 30 day follow-up after intracoronary angiography and/or PCI

    Possible or definite stent thrombosis

  9. Safety endpoints concerning intracoronary angiography and/or PCI

    Time frame: during 30 day follow-up after intracoronary angiography and/or PCI

    Ischemic stroke

  10. Safety endpoints concerning intracoronary angiography and/or PCI

    Time frame: during 30 day follow-up after intracoronary angiography and/or PCI

    Death

  11. Health care utilization

    Time frame: Within 30 days after inclusion

    Number of ambulance transfers

  12. Health care utilization

    Time frame: Up to 30 days after inclusion

    Duration of hospitalisation (days)

  13. Health care utilization

    Time frame: Within 30 days after inclusion

    Number of double invasive coronary angiography procedures

  14. Total health care costs

    Time frame: At 30 days

Sponsors and collaborators

Lead sponsor

Catharina Ziekenhuis Eindhoven

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2026
First posted
Sep 22, 2023
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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