Prehospital Triage of Patients With Suspected Non-ST-segment Elevation Acute Coronary Syndrome: the TRIAGE-ACS Study

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.

Study Overview

• Status: Completed
• Conditions: Unstable Angina; NSTEMI - Non-ST Segment Elevation MI; ACS
• Intervention / Treatment: Diagnostic test: PreHEART

• Study Type: Observational
• Enrollment (Actual): 1071

Contacts and Locations

Study Locations

• Netherlands
  • Noord-Brabant
    • Eindhoven, Noord-Brabant, Netherlands, 5623 EJ
      • Catharina Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients suspected for NSTE-ACS presenting in the prehospital setting with the EMS

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cohort 1 (reference group); 500 patients will be included as an observatory control group and as a reference group to the second cohort. The PreHEART score is calculated without further consequences for triage in the ambulance and are transferred to the ED of the nearest hospital for standard care.
Cohort 2 (intervention group); 500 patients will be included in the interventional cohort. The calculated PreHEART score has consequences for triage in the ambulance. If the PreHEART score is ≥ 5, the patient is classified as a high-risk patient for having NSTE-ACS. These patients are immediately transferred to the ED of the nearest PCI center for further diagnostic examination and to rule out other life-threatening pathologies. When the PreHEART score is ≤ 4, the patient is classified as a low-risk patient for having NSTE-ACS and is transferred to the ED of the nearest hospital without PCI facilities (non-PCI center) for further diagnostic work-up	Diagnostic test: PreHEART; The PreHEART score is validated for use in the pre-hospital setting.The score can be calculated based on five different elements: history, ECG, age, gender, and a Point-of-Care (POC)-Troponin. A minimum of 0 points and a maximum of 2 points can be scored in each element, the total PreHEART can contain a maximum of 10 points. The score of the history is based on the symptoms of the patient in accordance with the symptoms of a myocardial infarction. Based on the suspicion of ischemia on the ECG. Age will be based on the date of birth. Compared to the female gender, the male gender has higher risk of developing myocardial infarction and will be scored higher. The biomarker Troponin will be collected via intravenous access and measured using a POC-analyzer "I-Stat" from Abbott industries. In total 17 µl of blood is required to fill a cardiac Troponin I (cTnI) cartridge. Analyzing the blood will take approximately 10 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time from first medical contact to final invasive diagnostics and revascularization	Duration of time from first medical contact (in the EMS) to final invasive diagnostics and revascularization	Time from first medical contact by EMS to final invasive diagnostics and revascularization, up to 60 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with ischemic complications	Refractory ischemia, new myocardial infarction	2 years
Logistics during hospitalization	Time from first medical contact to invasive diagnostics Time from invasive diagnostics to revascularization Time from first medical contact to revascularization Duration of hospital admission Number of invasive procedures Numbers of transfers between hospitals by EMS services	30 days
Number of participants with Major Adverse Cardiac Events	All cause death Myocardial infarction Revascularization Stroke	7 and 30 days
Number of participants who suffer all cause death	Death from any cause	1 and 2 years
Number of participants with safety endpoints during invasive diagnostics and/or revascularization	Bleeding complications Contrast-induced nefropathy Possible or definite stent thrombosis Ischemic stroke Death	During hospitalization, up to 60 days
Economic endpoints	Total costs per patient stratified to low- and high-risk groups	During hospitalization, up to 60 days

Collaborators and Investigators

• Sponsor: 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Actual): December 19, 2022
• Study Completion (Actual): December 1, 2023

Study Registration Dates

• First Submitted: January 26, 2022
• First Submitted That Met QC Criteria: February 7, 2022
• First Posted (Actual): February 17, 2022

Study Record Updates

• Last Update Posted (Actual): February 12, 2024
• Last Update Submitted That Met QC Criteria: February 9, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Emergency Medical Services; Risk stratification; Triage; Prehospital
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Chest Pain; Angina Pectoris; Acute Coronary Syndrome; Angina, Unstable
• Other Study ID Numbers: TRIAGE ACS

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