Clinical trial NCT05243485: Prehospital Triage of Patients With Suspected Non-ST-segment Elevation Acute Coronary Syndrome: the TRIAGE-ACS Study
Official title: Prehospital Triage of Patients With Suspected Non-ST-segment Elevation Acute Coronary Syndrome: the TRIAGE-ACS Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ACS
NSTEMI - Non-ST Segment Elevation MI
Unstable Angina
Keywords: Prehospital
Risk stratification
Triage
Emergency Medical Services
Lead sponsor: Catharina Ziekenhuis Eindhoven
Sponsor class: OTHER
First posted: 2022-02-17
Enrollment: 1071
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients suspected for NSTE-ACS presenting in the prehospital setting with the EMS

Brief summary: With the Emergency Medical Services (EMS), no prehospital risk stratification and triage is performed for patients suspected of having an Non-ST-segment elevation Acute Coronary Syndrome (NSTE-ACS). While the latest ESC Guidelines recommend an early invasive strategy within 24 hours for all high risk NSTE-ACS patients and same-day transfer to a PCI (Percutaneous Coronary Intervention) center. With the potential emerging logistical problem surrounding this, prehospital risk stratification and triage can have great benefits in this population as well, especially in patients with a high risk of having an NSTE-ACS. The recently validated PreHEART score makes it possible to stratify patients in a low-risk and high-risk group for having a NSTE-ACS and gives the EMS the opportunity to make triage decisions in the prehospital setting. Patients with a high risk for having an NSTE-ACS are transferred directly to an PCI-center for further diagnostic work-up. Patients with a low risk for having NSTE-ACS and transferred to the ED of the nearest hospital without PCI facilities (non-PCI center) for further diagnostic work-up, resulting in an optimization of the regional care utilization.

This is the first study to focus on patients who are at a high risk of having an NSTE-ACS and to assess if whether prehospital triage using the PreHEART score is able to significantly reduce time to final invasive diagnostics and revascularization in patients in need of coronary revascularization.


Eligibility criteria: Inclusion Criteria:

* Chest pain suspected for NSTE-ACS
* Age ≥ 18 years
* Intention to transfer patient to Emergency Department

Exclusion Criteria:

* ST-segment elevation Acute Coronary Syndrome
* Post resuscitation patients
* Hemodynamic instability defined as Killip Class IV
* Suspected other life treating pathology
* Pregnancy
* No informed consent for data usage

Primary outcomes:
measure: Time from first medical contact to final invasive diagnostics and revascularization
timeFrame: Time from first medical contact by EMS to final invasive diagnostics and revascularization, up to 60 days
Secondary outcomes:
measure: Number of participants with ischemic complications
timeFrame: 2 years
measure: Logistics during hospitalization
timeFrame: 30 days
measure: Number of participants with Major Adverse Cardiac Events
timeFrame: 7 and 30 days
measure: Number of participants who suffer all cause death
timeFrame: 1 and 2 years
measure: Number of participants with safety endpoints during invasive diagnostics and/or revascularization
timeFrame: During hospitalization, up to 60 days
measure: Economic endpoints
timeFrame: During hospitalization, up to 60 days
Other outcomes:
Locations:
city: Eindhoven
country: Netherlands
facility: Catharina Hospital
state: Noord-Brabant
Study officials:
References:
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.