NCT06051110

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,239

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 4, 2023

Completed
18 days until next milestone

First Posted

Study publicly available on registry

September 22, 2023

Completed
9 days until next milestone

Study Start

First participant enrolled

October 1, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

March 18, 2026

Status Verified

March 1, 2026

Enrollment Period

1.2 years

First QC Date

September 4, 2023

Last Update Submit

March 17, 2026

Conditions

Acute Coronary SyndromeNon ST Segment Elevation Acute Coronary Syndrome

Keywords

EMSPOC-troponinCombined risk scoresPrehospital

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (14)

  • MACE

    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

    During or after index hospitalisation, up to 30 days

  • Alternative diagnoses other than NSTE-ACS

    during 30 day follow-up after inclusion

  • +9 more secondary outcomes

Study Arms (3)

Usual care

OTHER

Patients who receive usual care by EMS protocols

Other: Usual care

point-of-care troponin

OTHER

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

Combined risk scores

OTHER

Patients in who risk-stratification was performed by the use of a combined risk score in the EMS setting

Device: Combined risk score

Interventions

Combined risk scoreDEVICE

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

Combined risk scores
Usual careOTHER

Prehospital risk stratification by EMS protocols

Usual care
point-of-care troponinDEVICE

Prehospital risk stratification by the use of a POC-troponin

point-of-care troponin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Catharina hospital Eindhoven

Eindhoven, Netherlands

Location

Related Publications (5)

  • 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.

    PMID: 35383078BACKGROUND

  • 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.

    PMID: 34373266BACKGROUND

  • 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: 36755110BACKGROUND

  • 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.

    PMID: 34849660BACKGROUND

  • 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.

    PMID: 35863696BACKGROUND

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Pieter-Jan Vlaar, MD, PhD

    Catharina Ziekenhuis Eindhoven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 4, 2023

First Posted

September 22, 2023

Study Start

October 1, 2023

Primary Completion

December 1, 2024

Study Completion

January 1, 2026

Last Updated

March 18, 2026

Record last verified: 2026-03

Locations

NL(1)