Acute Coronary SyndromeNCT06051110
Individual Patient Data Meta-analysis on Prehospital Risk Assessment in Patients Suspected of Non-ST-segment Elevation Acute Coronary Syndrome
A study testing Combined risk score and point-of-care troponin in people with Acute Coronary Syndrome and Non ST Segment Elevation Acute Coronary Syndrome, run by Catharina Ziekenhuis Eindhoven at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Coronary Syndrome, Non ST Segment Elevation Acute Coronary Syndrome
- What is being tested?
- Combined risk score and point-of-care troponin
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,239 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Oct 2023to 1 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Combined risk score, Usual care, point-of-care troponin
- Keywords
- EMS, POC-troponin, Combined risk scores, Prehospital
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined risk scoreDevice
Prehospital risk stratification by the use of a combined clinical risk score including POC-troponin
Usual careOther
Prehospital risk stratification by EMS protocols
point-of-care troponinDevice
Prehospital risk stratification by the use of a POC-troponin
| Study group | Role | What they receive |
|---|---|---|
| Usual care | Other | Patients who receive usual care by EMS protocols Receives: 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 Receives: 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 Receives: Device: Combined risk score |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: During index hospitalization, up to 1 day in the ED
MACE
All cause death, myocardial infarction, revascularization
Measured: Within 30 days
Secondary outcomes (14)
MACE
All cause death, myocardial infarction, revascularization
Measured: 1 week
All cause death
Measured: Within 30 days and 1 year follow-up
The number of participants undergoing invasive coronary angiography
Measured: 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)
Measured: 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)
Measured: during 30 day follow-up after inclusion
Safety endpoints concerning intracoronary angiography and/or PCI
Bleeding complications
Measured: 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
Measured: during 30 day follow-up after intracoronary angiography and/or PCI
Safety endpoints concerning intracoronary angiography and/or PCI
Possible or definite stent thrombosis
Measured: during 30 day follow-up after intracoronary angiography and/or PCI
Safety endpoints concerning intracoronary angiography and/or PCI
Ischemic stroke
Measured: during 30 day follow-up after intracoronary angiography and/or PCI
Safety endpoints concerning intracoronary angiography and/or PCI
Death
Measured: during 30 day follow-up after intracoronary angiography and/or PCI
Health care utilization
Number of ambulance transfers
Measured: Within 30 days after inclusion
Health care utilization
Duration of hospitalisation (days)
Measured: Up to 30 days after inclusion
Health care utilization
Number of double invasive coronary angiography procedures
Measured: Within 30 days after inclusion
Total health care costs
Measured: At 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2023
- Study start1 Oct 2023
- Primary completion1 Dec 2024
- Study completion1 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5,239 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catharina Ziekenhuis Eindhoven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pieter-Jan Vlaar, Catharina Ziekenhuis Eindhoven
- Investigators
- Pieter-Jan Vlaar, MD, PhD, Principal investigator, Catharina Ziekenhuis Eindhoven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06051110
- Sponsor's protocol ID
- nWMO-2023.086
- Status last verified
- Mar 2026
- First submitted
- 4 Sep 2023
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 35383078Sagel 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.
PubMed 34373266Camaro 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.
PubMed 36755110Tolsma 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.
PubMed 34849660Demandt 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.
PubMed 35863696
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individual Patient Data Meta-analysis on Prehospital Risk Assessment in Patients Suspected of Non-ST-segment Elevation Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT06051110
- Acronym / sponsor ID
- nWMO-2023.086
- Keywords
- EMS, POC-troponin, Combined risk scores, Prehospital
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5,239 participants (actual)
- Lead sponsor
- Catharina Ziekenhuis EindhovenUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Jan 2026 (actual)
- First posted
- 22 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Usual care | Other | Other: Usual carePatients who receive usual care by EMS protocols |
| point-of-care troponin | Other | Device: point-of-care troponinPatients in who risk-stratification was performed by the use of a point-of-care troponin in the EMS setting |
| Combined risk scores | Other | Device: Combined risk scorePatients in who risk-stratification was performed by the use of a combined risk score in the EMS setting |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combined risk scorePrehospital risk stratification by the use of a combined clinical risk score including POC-troponin | Device | Combined risk scores |
| Usual carePrehospital risk stratification by EMS protocols | Other | Usual care |
| point-of-care troponinPrehospital risk stratification by the use of a POC-troponin | Device | point-of-care troponin |
Primary outcome
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)
MACE
Time frame: Within 30 days
All cause death, myocardial infarction, revascularization
14 secondary outcomes
MACE
Time frame: 1 week
All cause death
Time frame: Within 30 days and 1 year follow-up
The number of participants undergoing invasive coronary angiography
Time frame: During or after index hospitalisation, up to 30 days
The number of participants undergoing coronary revascularisation
Time frame: During or after index hospitalisation, up to 30 days
Alternative diagnoses other than NSTE-ACS
Time frame: during 30 day follow-up after inclusion
Safety endpoints concerning intracoronary angiography and/or PCI
Time frame: during 30 day follow-up after intracoronary angiography and/or PCI
Safety endpoints concerning intracoronary angiography and/or PCI
Time frame: during 30 day follow-up after intracoronary angiography and/or PCI
Safety endpoints concerning intracoronary angiography and/or PCI
Time frame: during 30 day follow-up after intracoronary angiography and/or PCI
Safety endpoints concerning intracoronary angiography and/or PCI
Time frame: during 30 day follow-up after intracoronary angiography and/or PCI
Safety endpoints concerning intracoronary angiography and/or PCI
Time frame: during 30 day follow-up after intracoronary angiography and/or PCI
Health care utilization
Time frame: Within 30 days after inclusion
Health care utilization
Time frame: Up to 30 days after inclusion
Health care utilization
Time frame: Within 30 days after inclusion
Total health care costs
Time frame: At 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Background: PubMed 35383078Demandt 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.
- Background: PubMed 34373266Sagel 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.
- Background: PubMed 36755110Camaro 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.
- Background: PubMed 34849660Tolsma 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.
- Background: PubMed 35863696Demandt 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pieter-Jan Vlaar, MD, PhD principal investigator
Catharina Ziekenhuis Eindhoven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined risk score and point-of-care troponin in people with Acute Coronary Syndrome and Non ST Segment Elevation Acute Coronary Syndrome, run by Catharina Ziekenhuis Eindhoven at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with the diagnosis NSTE-ACS (time frame: During index hospitalization, up to 1 day in the ED). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06051110, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.