Pre Hospital Triage of Patients at Intermediate and High Risk for ACS

NCT07252245 | Not Yet Recruiting DMC

• 2 other identifiers: NL-01080710390042410064
• Study Type: interventional
• Target: 1,048
• Locations: 1 country
• Sites: 1

Brief Summary

RESEARCH QUESTION: Is a treatment strategy that includes direct referral to a PCI center for intermediate to high-risk patients with non-ST elevation acute coronary syndrome (NSTE-ACS), both cost-effective and non-inferior for major adverse cardiac events (MACE)? HYPOTHESIS: Prehospital triage with the modified \[History-ECG-Age-Risk factors\] (HEAR) score and a high sensitivity (hs) point-of-care troponin (POCT) leads to a faster diagnosis of ACS, faster time to coronary angiography (CAG) and/or treatment with PCI, shorter length of stay, quicker availability of ambulances and more satisfaction and quality of life of patients. STUDY DESIGN: Randomized clinical trial. STUDY POPULATION: Patients ≥18 years with an intermediate to high risk for NSTE -ACS (defined as a modified HEAR score ≥ 4) INTERVENTION: applying modified HEAR score and hs POCT to identify patients for direct rule out (very low risk), transfer to the nearest hospital for rapid rule-out and/or fast-track diagnosis by CT coronary imaging (intermediate risk) or direct referral to a PCI center for CAG (high risk). USUAL CARE/COMPARISON: Assessment of ACS at the nearest hospital. In case PCI is scheduled: transfer to nearest PCI center. OUTCOME MEASURES: primary endpoints: healthcare costs and non-inferiority for MACE (all cause death, confirmed ACS, re ACS, and unplanned PCI or CABG) at 30 days. Secondary: MACE after rule out ACS at 30 days, Quality of life (EQ5D5L) and cost-effectiveness at 12 months. SAMPLE SIZE: 1048 patients. COST-EFFECTIVENESS ANALYSIS / BIA: It is expected that the intervention group will reduce healthcare costs and potentially improve health-related quality of life in this target population. Cost-effectiveness will be expressed as cost per QALY gained. We assume a large potential saving more than € 37 million if 100% implemented. TIME SCHEDULE: 48 months; 36 month inclusion, follow-up 12 months

Conditions

Non ST Segment Elevation Acute Coronary Syndrome

Keywords

HEART score; NSTE-ACS; Pre-hospital triage; high risk ACS; intermediate risk ACS; point-of-care troponin

Outcome Measures

Primary Outcomes (2)

• Non-inferiority for MACE

  MACE (% all cause death, confirmed ACS, re ACS, and unplanned PCI or CABG). Risk differences will be calculated along with 95% confidence intervals

  from enrollment to end of treatment at 30 days and 12 months

• Healthcare costs

  healthcare costs in EURO

  from enrollment to end of treatment at 30 days and 12 months

Secondary Outcomes (3)

• MACE after ruling out ACS

  from enrollment to end of treatment at 30 days

• Quality of life measured with the EQ5D5L

  from enrollment to end of treatment at 30 days and 12 months

• Cost-effectiveness analysis (CEA)

  from enrollment to end of treatment at 12 months

Study Arms (2)

Intervention group

ACTIVE COMPARATOR

Integrating the HEAR score and hs POC troponin into pre hospital triage decision-making:

Other: Integrating the HEAR score and hs POC troponin into pre hospital triage decision-making:

Standard care group

NO INTERVENTION

intermediate and high risk patients referred to the nearest hospital for standard care. The ACS rule-out protocol follows the 2023 Guidelines of the European Society of Cardiology (ESC). In confirmed cases of ACS, patients should be scheduled for invasive coronary angiography within the recommended time window as outlined by the ESC guidelines

Interventions

Integrating the HEAR score and hs POC troponin into pre hospital triage decision-making: OTHER

Integrating the HEAR score and hs POC troponin into pre hospital triage decision-making: low risk (HEAR score 4 and hs POC troponin \< 99th percentile upper reference limit (URL)) will be treated conservatively (i.e. referred to the general practitioner); intermediate risk (HEAR score ≥5 and hs POC troponin \< 99th percentile URL or HEAR score 4-6 with intermediate elevated hs POC troponin (i.e. hs POC troponin between 1 and 3 times the 99th percentile URL) are admitted to the nearest hospital with a rapid rule out strategy or recommendation for fast-track coronary CT imaging (CTCA); high risk group (HEAR ≥ 7 ánd hs POC troponin \> 99th percentile URL or any HEAR score with hs POC troponin 3x \> 99th URL will be directly referred to a PCI center

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• All out-of-hospital patients with chest pain or symptoms suggestive of ACS with an indication for transfer to the (cardiac) emergency department to evaluate and rule out ACS
• Modified HEAR(T) score ≥ 4
• The patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.

You may not qualify if:

• Electrocardiographic ST-segment elevation (STEMI)
• Patients with confirmed myocardial infarction, PCI or CABG \<14 days prior to inclu-sion
• Patients presenting an obvious non-cardiac cause for the chest complaints who need evaluation at an emergency department, e.g. trauma, pneumothorax, sepsis, etc.
• Patients in comatose state, defined as an EMV \<8
• Patients with known cognitive impairment
• Pregnancy or intention to become pregnant during the course of the study
• Patients presenting with cardiogenic shock, defined as: systolic blood pressure \<90mmHg and heart rate \>100 and peripheral oxygen saturation \<90% (without oxygen administration)
• Patients presenting with syncope
• Patients presenting with signs of heart failure
• Patients presenting with second or third degree atrioventricular block
• Patients without known supraventricular tachycardia i.e. unknown atrial fibrillation (known atrial fibrillation with adequate rate control can be included)
• Patients with known end-stage renal disease (dialysis and/or GFR \< 30 ml/min)
• Patients without a pre-hospital 12-lead ECG performed or available
• Patients suspicious of aortic dissection or pulmonary embolism
• Communication issues with patient/language barrier

Sponsors & Collaborators

• Cyril Camaro: lead
• Ambulance services Veiligheidsregio Gelderland-Zuid: collaborator
• Canisius Wilhelmina Ziekenhuis (CWZ): collaborator
• Slingeland Hospital: collaborator
• Maas Hospital Pantein: collaborator
• Rijnstate Hospital: collaborator
• RAV Brabant MWN: collaborator

Study Sites (1)

Radboudumc Nijmegen, The Netherlands

Nijmegen, 6525 GA, Netherlands

Location

Related Links

• Related Info

Study Officials

• Cyril Camaro, MD

  Radboudumc / department Cardiology 616

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cyril Camaro, MD

CONTACT

+31243616785; articastudie.cardio@radboudumc.nl

Cyril Camaro

CONTACT

+31243616785; cyril.camaro@radboudumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Cyril Camaro, PI ARTICA-2

Model Details: Strategy study: A) intervention group: Integrating the HEAR score and hs POC troponin: pre- hospital triage decision-making for intermediate and high risk patients: B) Standard care group: all intermediate and high risk patients are referred to the nearest hospital to rule-out or rule-in ACS

Study Record Dates

• First Submitted: September 30, 2025
• First Posted: November 26, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): February 1, 2030
• Last Updated: November 26, 2025

Record last verified: 2025-11

Locations

NL (1)