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.

Study Overview

• Status: Completed
• Conditions: Acute Coronary Syndrome; Non ST Segment Elevation Acute Coronary Syndrome
• Intervention / Treatment: Other: Usual care; Device: point-of-care troponin; Device: Combined risk score

• Study Type: Interventional
• Enrollment (Actual): 5239
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Eindhoven, Netherlands
    • Catharina Hospital Eindhoven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Usual care; Patients who receive usual care by EMS protocols	Other: Usual care; Prehospital risk stratification by EMS protocols
Other: point-of-care troponin; Patients in who risk-stratification was performed by the use of a point-of-care troponin in the EMS setting	Device: point-of-care troponin; Prehospital risk stratification by the use of a POC-troponin
Other: Combined risk scores; Patients in who risk-stratification was performed by the use of a combined risk score in the EMS setting	Device: Combined risk score; Prehospital risk stratification by the use of a combined clinical risk score including POC-troponin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with the diagnosis NSTE-ACS	Diagnosis of NSTE-ACS (NSTEMI or unstable AP) during index hospitalization (as assessed by the treating physician)	During index hospitalization, up to 1 day in the ED
MACE	All cause death, myocardial infarction, revascularization	Within 30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MACE	All cause death, myocardial infarction, revascularization	1 week
All cause death		Within 30 days and 1 year follow-up
The number of participants undergoing invasive coronary angiography		During or after index hospitalisation, up to 30 days
The number of participants undergoing coronary revascularisation	percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG)	During or after index hospitalisation, up to 30 days
Alternative diagnoses other than NSTE-ACS	If no NSTE-ACS is diagnosed, what is the alternative diagnosis (such as pulmonary embolism, aortic dissection, pneumothorax)	during 30 day follow-up after inclusion
Safety endpoints concerning intracoronary angiography and/or PCI	Bleeding complications	during 30 day follow-up after intracoronary angiography and/or PCI
Safety endpoints concerning intracoronary angiography and/or PCI	Contrast-induced nephropathy Possible or definite stent thrombosis Ischemic stroke Death	during 30 day follow-up after intracoronary angiography and/or PCI
Safety endpoints concerning intracoronary angiography and/or PCI	Possible or definite stent thrombosis	during 30 day follow-up after intracoronary angiography and/or PCI
Safety endpoints concerning intracoronary angiography and/or PCI	Ischemic stroke	during 30 day follow-up after intracoronary angiography and/or PCI
Safety endpoints concerning intracoronary angiography and/or PCI	Death	during 30 day follow-up after intracoronary angiography and/or PCI
Health care utilization	Number of ambulance transfers	Within 30 days after inclusion
Health care utilization	Duration of hospitalisation (days)	Up to 30 days after inclusion
Health care utilization	Number of double invasive coronary angiography procedures	Within 30 days after inclusion
Total health care costs		At 30 days

Collaborators and Investigators

• Sponsor: Catharina Ziekenhuis Eindhoven
• Investigators: Principal Investigator: Pieter-Jan Vlaar, MD, PhD, Catharina Ziekenhuis Eindhoven

Publications and helpful links

General Publications

• Sagel D, Vlaar PJ, van Roosmalen R, Waardenburg I, Nieuwland W, Lettinga R, van Barneveld R, Jorna E, Kijlstra R, van Well C, Oomen A, Bartels L, Anthonio R, Hagens V, Hofma S, Gu Y, Drenth D, Addink R, van Asselt T, van der Meer P, Lipsic E, Juarez Orozco L, van der Harst P. Prehospital risk stratification in patients with chest pain. Emerg Med J. 2021 Nov;38(11):814-819. doi: 10.1136/emermed-2020-210212. Epub 2021 Aug 9.
• Demandt JPA, Zelis JM, Koks A, Smits GHJM, van der Harst P, Tonino PAL, Dekker LRC, van Het Veer M, Vlaar PJ. Prehospital risk assessment in patients suspected of non-ST-segment elevation acute coronary syndrome: a systematic review and meta-analysis. BMJ Open. 2022 Apr 5;12(4):e057305. doi: 10.1136/bmjopen-2021-057305.
• 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.
• Tolsma RT, Fokkert MJ, van Dongen DN, Badings EA, van der Sluis A, Slingerland RJ, van 't Riet E, Ottervanger JP, van 't Hof AWJ. Referral decisions based on a pre-hospital HEART score in suspected non-ST-elevation acute coronary syndrome: final results of the FamouS Triage study. Eur Heart J Acute Cardiovasc Care. 2022 Feb 8;11(2):160-169. doi: 10.1093/ehjacc/zuab109.
• Demandt JPA, Koks A, Haest R, Heijmen E, Thijssen E, Otterspoor LC, van Veghel D, El Farissi M, Eerdekens R, Vervaat F, Pijls NHJ, Veer MVT, Tonino PAL, Dekker LRC, Vlaar PJ. Prehospital triage of patients with suspected non-ST-segment elevation acute coronary syndrome: Rationale and design of the TRIAGE-ACS study. Contemp Clin Trials. 2022 Aug;119:106854. doi: 10.1016/j.cct.2022.106854. Epub 2022 Jul 18.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2023
• Primary Completion (Actual): December 1, 2024
• Study Completion (Actual): January 1, 2026

Study Registration Dates

• First Submitted: September 4, 2023
• First Submitted That Met QC Criteria: September 18, 2023
• First Posted (Actual): September 22, 2023

Study Record Updates

• Last Update Posted (Actual): March 18, 2026
• Last Update Submitted That Met QC Criteria: March 17, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Prehospital; EMS; POC-troponin; Combined risk scores
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Myocardial Ischemia; Acute Coronary Syndrome
• Other Study ID Numbers: nWMO-2023.086

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No