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

Unstable Angina Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05243485
• Other study ID #: TRIAGE ACS
• Status: Completed
• Start date: April 1, 2021
• Est. completion date: December 1, 2023

Study information

• Verified date: February 2024
• Source: Catharina Ziekenhuis Eindhoven
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1071
• Est. completion date: December 1, 2023
• Est. primary completion date: December 19, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• ACS
• Acute Coronary Syndrome
• Angina, Unstable
• NSTEMI - Non-ST Segment Elevation MI
• Unstable Angina

Intervention

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.

Locations

Country	Name	City	State
Netherlands	Catharina Hospital	Eindhoven	Noord-Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Catharina Ziekenhuis Eindhoven

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of participants with ischemic complications	Refractory ischemia, new myocardial infarction	2 years
Secondary	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
Secondary	Number of participants with Major Adverse Cardiac Events	All cause death Myocardial infarction Revascularization Stroke	7 and 30 days
Secondary	Number of participants who suffer all cause death	Death from any cause	1 and 2 years
Secondary	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
Secondary	Economic endpoints	Total costs per patient stratified to low- and high-risk groups	During hospitalization, up to 60 days