Pre Hospital Triage of Patients at Intermediate and High Risk for ACS
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCyril Camaro
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Integrating the HEAR score and hs POC troponin into pre hospital triage decision-making:
Other interventionIntegrating 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 4 and onset symptoms \< 1 hour ago, 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
Treatment groups
1,048 Participants
are divided into 2 treatment groupsGroup A: Intervention groupActive comparator 1 intervention
Group B: Standard care groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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
Time frame
from enrollment to end of treatment at 30 days and 12 months2
Healthcare costs
healthcare costs in EURO
Time frame
from enrollment to end of treatment at 30 days and 12 monthsSecondary outcomes
1
MACE after ruling out ACS
30-day incidence of MACE in %. Risk differences will be calculated along with 95% confidence intervals
Time frame
from enrollment to end of treatment at 30 days2
Quality of life measured with the EQ5D5L
Quality of life
Time frame
from enrollment to end of treatment at 30 days and 12 months3
Cost-effectiveness analysis (CEA)
Incremental cost-effectiveness ratios (ICERs) will be calculated
Time frame
from enrollment to end of treatment at 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Cyril Camaro
Lead sponsor
Radboud University Medical Center
Sponsor institution
Canisius-Wilhelmina Hospital
Collaborator
Slingeland Hospital
Collaborator
Maas Hospital Pantein
Collaborator
Rijnstate Hospital
Collaborator
RAV Brabant MWN
Collaborator
Ambulance services Veiligheidsregio Gelderland-Zuid
Collaborator
Source ClinicalTrials.gov