To determine the effectiveness of the HEART (History, Electrocardiogram (ECG), Age, Risk factors, Troponin) score with POC hs-cTnI testing by ambulance nurses in safely ruling out ACS and increasing the number of patients left at home after…
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Phase 1 compares analytical performance of the POC device to conventional cTnT
in the central laboratory. In phase 2 HEART scores will be compared between
intervention and control.
The main study parameter in phase 3 is the percent change in number of patients
left at home after ambulance nurse consultation.
Secondary outcome
Secondary endpoints are the occurrence of Major Adverse Cardiac Events (MACE),
defined as death, ACS or percutaneous coronary intervention (PCI) 6 weeks after
ED assessment. Furthermore (diagnostic) performance of POC device, sensitivity
and specificity of the HEART - and HEAR (HEART score without Troponin
measurement) score will be assessed. Furthermore a 'delta' POC hs-cTnI will be
assessed which might lead tot faster time-to-diagnosis.
Background summary
Emergency departments (EDs) are increasingly overcrowded leading to worse
patient outcomes and increased healthcare costs. Chest pain is one of the main
reasons for ED evaluation. However, over 80% of chest pain referrals are
discharged on the same day after ruling out acute cardiovascular disease.
Improved prehospital triage for safe rule-out of acute coronary syndrome (ACS)
by ambulance nurses with a point-of-care (POC) high-sensitivity (hs) cardiac
Troponin I (cTnI) test, can aid in reducing unnecessary hospital referrals and
thus reduce ED overcrowding.
Study objective
To determine the effectiveness of the HEART (History, Electrocardiogram (ECG),
Age, Risk factors, Troponin) score with POC hs-cTnI testing by ambulance nurses
in safely ruling out ACS and increasing the number of patients left at home
after ambulance nurse consultation.
Study design
The study consists of three phases. Phase 1, a test-tube lab research, focuses
on the analytical performance of the POC device. Phase 2 focuses on the
clinical performance of the POC device in a controlled (in-hospital) setting.
Phase 3 is a randomized controlled trial which divides chest pain patients in
either intervention, HEART score with POC hs-cTnI by ambulance nurses and
subsequent cardiologist consultation, and control, current standard of care
with prehospital cardiologist consultation.
Intervention
In phase 1 patients presenting to the ED or CEU will have POC hs-cTnI tested by
both CEU - or ED nurses and laboratory professionals. Analytical performances
of the POC device will be compared to laboratory hs-cardiac Troponin T (cTnT)
analyzed through the standard blood-draw by venepuncture. Phase 2 will have POC
hs-cTnI tested by CEU - or ED nurses after which HEART scores will be
calculated by treating physicians. HEART scores and clinical outcomes with the
use of the POC device will be compared to standard care (HEART score including
laboratory hs-cTnT). In phase 3 chest pain patients presenting to the regional
EMS will be randomized in the ambulance to either intervention, POC hs-cTnI
testing and subsequent HEART score calculation by ambulance nurse, or control,
standard care including cardiologist consultation. After HEART score
calculation by the ambulance nurse patients will either be left at home (HEART
score <3 including low cTnI) or consulted to a triage cardiologist after which
patients can be referred to one of the three regional hospitals or left at
home. If patients are referred to the hospital, a second HEART score will be
calculated upon arrival with POC hs-cTnI.
Study burden and risks
Low risk patients will have a POC assessment through fingerstick while they
otherwise might not have been referred to the hospital. All other patients will
benefit from faster and more accurate triage and have a lower risk of missed
ACS. Over 80% of patients with chest pain are discharged from the ED without
acute pathology on the same day as presentation. By selecting these low risk
patients in the prehospital setting they are spared a stressful and sometimes
long ED visit.
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
Inclusion criteria
Adults (aged 18 years or older) presenting to the EMS with chest pain suspected
to be of cardiac origin with good understanding of Dutch or English language
and capable of giving informed consent.
Exclusion criteria
Since the Siemens Healthineers Atellica VTLi is validated in chest pain
experiencing chest pain for more than two hours, patients with chest pain since
less than two hours will be excluded. Furthermore, the triage cardiologist is
available on weekdays from 08.00-21.00. Patients presenting to the EMS
paramedic outside of these hours are excluded from the study.
Patients with ST-elevation on first ECG, non-cardiac chest pain (e.g. traumata,
pneumonia, pneumothorax) or in cardiogenic shock/out-of-hospital cardiac arrest
will be excluded. Furthermore if the ambulance nurse estimates that the time
from inclusion and consultation will lead to worse patient outcomes they can
choose to present patients directly to the ED or CEU. If patients are presented
to another hospital then the three regional participating hospitals they will
also be excluded. Patients in detention centers or asylum centers at the moment
of triage will be excluded from the study since follow-up is not possible for
these patients.
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| CCMO | NL80873.000.22 |
| Other | NL9475 |