Clinical trial NCT06051110: Individual Patient Data Meta-analysis on Prehospital Risk Assessment in Patients Suspected of Non-ST-segment Elevation Acute Coronary Syndrome
Official title: Individual Patient Data Meta-analysis on Prehospital Risk Assessment in Patients Suspected of Non-ST-segment Elevation Acute Coronary Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Coronary Syndrome
Non ST Segment Elevation Acute Coronary Syndrome
Keywords: EMS
POC-troponin
Combined risk scores
Prehospital
Lead sponsor: Catharina Ziekenhuis Eindhoven
Sponsor class: OTHER
First posted: 2023-09-22
Enrollment: 8000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants with the diagnosis NSTE-ACS
timeFrame: During index hospitalization, up to 1 day in the ED
measure: MACE
timeFrame: Within 30 days
Secondary outcomes:
measure: MACE
timeFrame: 1 week
measure: All cause death
timeFrame: Within 30 days and 1 year follow-up
measure: The number of participants undergoing invasive coronary angiography
timeFrame: During or after index hospitalisation, up to 30 days
measure: The number of participants undergoing coronary revascularisation
timeFrame: During or after index hospitalisation, up to 30 days
measure: Alternative diagnoses other than NSTE-ACS
timeFrame: during 30 day follow-up after inclusion
measure: Safety endpoints concerning intracoronary angiography and/or PCI
timeFrame: during 30 day follow-up after intracoronary angiography and/or PCI
measure: Safety endpoints concerning intracoronary angiography and/or PCI
timeFrame: during 30 day follow-up after intracoronary angiography and/or PCI
measure: Safety endpoints concerning intracoronary angiography and/or PCI
timeFrame: during 30 day follow-up after intracoronary angiography and/or PCI
measure: Safety endpoints concerning intracoronary angiography and/or PCI
timeFrame: during 30 day follow-up after intracoronary angiography and/or PCI
measure: Safety endpoints concerning intracoronary angiography and/or PCI
timeFrame: during 30 day follow-up after intracoronary angiography and/or PCI
measure: Health care utilization
timeFrame: Within 30 days after inclusion
measure: Health care utilization
timeFrame: Up to 30 days after inclusion
measure: Health care utilization
timeFrame: Within 30 days after inclusion
measure: Total health care costs
timeFrame: At 30 days
Other outcomes:
Locations:
city: Eindhoven
country: Netherlands
facility: Catharina hospital Eindhoven
Study officials:
affiliation: Catharina Ziekenhuis Eindhoven
name: Pieter-Jan Vlaar, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.