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

NCT ID: NCT05243485

Last Updated: 2024-02-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1071 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-04-01
• Study Completion Date: 2023-12-01

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.

Conditions

ACS; NSTEMI - Non-ST Segment Elevation MI; Unstable Angina

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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

PreHEART

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Catharina Ziekenhuis Eindhoven

OTHER

Sponsor Role: lead

Responsible Party

Pieter-Jan Vlaar

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Catharina Hospital

Eindhoven, North Brabant, Netherlands

Countries

Netherlands

References

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.

Reference Type: BACKGROUND

PMID: 34373266 (View on PubMed)

Demandt JPA, Koks A, Sagel D, Haest R, Heijmen E, Thijssen E, El Farissi M, Eerdekens R, van der Harst P, van 't Veer M, Dekker L, Tonino P, Vlaar PJ. External validation of the preHEART score and comparison with current clinical risk scores for prehospital risk assessment in patients with suspected NSTE-ACS. Emerg Med J. 2024 Sep 25;41(10):610-616. doi: 10.1136/emermed-2023-213866.

Reference Type: DERIVED

PMID: 39074964 (View on PubMed)

Demandt J, Koks A, Sagel D, van Hattem VAE, Haest RJ, Heijmen E, Thijssen H, Otterspoor LC, van Veghel D, Eerdekens R, El Farissi M, Teeuwen K, Wijnbergen I, van der Harst P, Pijls NHJ, van 't Veer M, Tonino PAL, Dekker LRC, Vlaar PJ. Prehospital risk assessment and direct transfer to a percutaneous coronary intervention centre in suspected acute coronary syndrome. Heart. 2024 Feb 23;110(6):408-415. doi: 10.1136/heartjnl-2023-323346.

Reference Type: DERIVED

PMID: 38040452 (View on PubMed)

Other Identifiers

TRIAGE ACS

Identifier Type: -

Identifier Source: org_study_id