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

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

Interventions

OTHER

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

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

Sponsors & Collaborators

• Ambulance services Veiligheidsregio Gelderland-Zuid

  collaborator UNKNOWN

• Canisius Wilhelmina Ziekenhuis (CWZ)

  collaborator UNKNOWN

• Slingeland Hospital

  collaborator OTHER

• Maas Hospital Pantein

  collaborator OTHER

• Rijnstate Hospital

  collaborator OTHER

• RAV Brabant MWN

  collaborator OTHER

• Cyril Camaro

  lead OTHER

Principal Investigators

• Cyril Camaro, MD · Radboudumc / department Cardiology 616

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-01-01

Primary Completion

2029-01-01

Completion

2030-02-01

Countries

• Netherlands

Study Locations