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ACSNCT05243485

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

An observational study of ACS and NSTEMI - Non-ST Segment Elevation MI, run by Catharina Ziekenhuis Eindhoven at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
PreHEART
Type of treatment
Injection or infusion
How many people
1,071 participants
Where
1 siteNetherlands
Study dates
1 Apr 2021to 1 Dec 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Catharina Hospital

    Eindhoven, North Brabant, 5623 EJ

Other trials in Netherlands

About this 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.

Being tested
PreHEART
Keywords
Prehospital, Risk stratification, Triage, Emergency Medical Services
Medical subject headings
Non-ST Elevated Myocardial Infarction, Angina, Unstable

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PreHEARTDiagnostic 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.

Study groups in NCT05243485
Study groupRoleWhat they receive
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
Receives: Diagnostic Test: PreHEART

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Time from first medical contact by EMS to final invasive diagnostics and revascularization, up to 60 days

Secondary outcomes (6)

  1. Number of participants with ischemic complications

    Refractory ischemia, new myocardial infarction

    Measured: 2 years

  2. 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

    Measured: 30 days

  3. Number of participants with Major Adverse Cardiac Events

    All cause death Myocardial infarction Revascularization Stroke

    Measured: 7 and 30 days

  4. Number of participants who suffer all cause death

    Death from any cause

    Measured: 1 and 2 years

  5. 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

    Measured: During hospitalization, up to 60 days

  6. Economic endpoints

    Total costs per patient stratified to low- and high-risk groups

    Measured: During hospitalization, up to 60 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Feb 2022
  2. Study start1 Apr 2021
  3. Primary completion19 Dec 2022
  4. Study completion1 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,071 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05243485
Sponsor's protocol ID
TRIAGE ACS
Status last verified
Feb 2024
First submitted
26 Jan 2022
Last updated
12 Feb 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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.

    PubMed 34373266

  • 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.

    PubMed 39074964

  • 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.

    PubMed 38040452

Questions about this trial

What is this clinical trial studying?

An observational study of ACS and NSTEMI - Non-ST Segment Elevation MI, run by Catharina Ziekenhuis Eindhoven at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time from first medical contact to final invasive diagnostics and revascularization (time frame: Time from first medical contact by EMS to final invasive diagnostics and revascularization, up to 60 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05243485, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2024.

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