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

Completed

• Conditions: Unstable Angina; NSTEMI - Non-ST Segment Elevation MI; ACS
• Interventions: Diagnostic Test: PreHEART

• Registration Number: NCT05243485
• Lead Sponsor: Catharina Ziekenhuis Eindhoven

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-01
• Study First Submitted: 2022-01-26
• Study First Submitted QC: 2022-02-07
• Study First Posted: 2022-02-17
• Primary Completion: 2022-12-19
• Study Completion: 2023-12-01
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-09
• Last Update Posted: 2024-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1071

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort 2 (intervention group)	PreHEART	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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Number of participants with ischemic complications	2 years	Refractory ischemia, new myocardial infarction
Number of participants with safety endpoints during invasive diagnostics and/or revascularization	During hospitalization, up to 60 days	Bleeding complications Contrast-induced nefropathy Possible or definite stent thrombosis Ischemic stroke Death
Logistics during hospitalization	30 days	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
Number of participants who suffer all cause death	1 and 2 years	Death from any cause
Number of participants with Major Adverse Cardiac Events	7 and 30 days	All cause death Myocardial infarction Revascularization Stroke
Economic endpoints	During hospitalization, up to 60 days	Total costs per patient stratified to low- and high-risk groups

Trial Locations

Locations (1)

Catharina Hospital; 🇳🇱 Eindhoven, Noord-Brabant, Netherlands