To assess whether a prehospital rule-out strategy using the modified HEART score and an ambulant single troponin assessment with point-of-care (POC) troponin T device employed by paramedics can cost-efficiently and safely rule out ACS as compared to…
ID
Source
Brief title
Condition
- Other condition
- Cardiac disorders, signs and symptoms NEC
Synonym
Health condition
hartaandoeningen, non ST elevatie acuut coronair syndroom en pijn op de borst
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary aim of the study is the assessment of health care costs. Cost and
quality adjusted life years (QALYs) will be measured on a per patient basis
over the relevant time path in which the (most important) differences in both
measures between both arms manifest themselves. Cost-effectiveness will be
expressed in terms of cost per QALY gained.
Secondary outcome
The secondary aim is to determine safety, as shown by previous studies i.e.
major adverse cardiac events (MACE) less than 1.5% at one, six and 12 months.
At last we will evaluate the potential improvement in patient care, both for
patient convenience (by using questionnaires after 30 days of follow-up
concerning the patient*s experience: direct reassurance for very low risk of
NSTE ACS as for health care costs (no ambulance transfer and admittance to the
ER).
Background summary
Of all patients suspected of non ST-segment elevation acute coronary syndrome
(NSTE-ACS), the majority is currently presented at hospital emergency
departments (ER) to rule out ACS. In patients with a low risk profile, NSTE-ACS
is however rarely found. All these presentations on the other hand contribute
to the overcrowding of the ER and health care costs. Recent studies have
suggested that using a simple prehospital rule-out strategy including the
modified HEART score with ambulant troponin T assessment, can help ambulance
personnel to discriminate between high and low risk of NSTE-ACS. In the latter,
it was shown that unnecessary ER presentations may potentially be prevented and
costs reduced
HEALTH CARE EFFICIENCY PROBLEM: Emergency departments are increasingly
overcrowded and ambulance services are confronted with more patient transfers.
In 2012 the National Institute for Public Health and the Environment (RIVM)
revealed that 140.369 patients were evaluated with chest pain, but eventually
no ACS or angina pectoris was found. Almost 75.000 patients (53%) undergo
observation at the ER, but are discharged without a final diagnosis of NSTE-ACS
[7]. The Dutch Health Authority (NZA) has become aware of this *chest pain*
burden and made a recent general recommendation
Study objective
To assess whether a prehospital rule-out strategy using the modified HEART
score and an ambulant single troponin assessment with point-of-care (POC)
troponin T device employed by paramedics can cost-efficiently and safely rule
out ACS as compared to standard ER evaluation.
HYPOTHESIS: pre-hospital triage in patients with low risk of NSTE-ACS will
reveal a large saving in health care resources in favor of the pre-hospital
rule strategy with additional GP management. At 12 months the strategy will
corroborate with a very low event rate (MACE rate < 1.5%
Study design
Prospective, randomized controlled, investigator-initiated, multicentre study
Intervention
Patients will be randomised 1:1, to (A) a management by their general
practitioner or (B) regular hospital evaluation, in which patients will undergo
rule out of ACS at the chest pain unit according to local protocol.
Study burden and risks
Previous investigation have shown that one third of the patients presenting
with ACS-symptoms are at low risk for ACS. This group will be randomly assigned
to standard hospital evaluation or prehospital management (general
practitioner, conservative). Randomised patients are all at low risk for ACS
and might benefit from conservative prehospital treatment, because this
strategy is safe and transfer with hospitalisation can lead to unnecessary
utility of medical resources and increase costs.
Geert Grooteplein 10
Nijmegen 6525 GA
NL
Geert Grooteplein 10
Nijmegen 6525 GA
NL
Listed location countries
Age
Inclusion criteria
Patients with symptoms suggestive for non ST-segment elevation acute coronary
syndrome with symptom duration of at least two hours, a HEART score equal or
less than 3 and a point of care troponin below the lower limit of the measuring
range
Exclusion criteria
- Patients with an acute ST elevation myocardial infarction
- 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 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 heart rhythm disorders and second or third degree
atrioventricular block
- Patients with known end-stage renal disease (dialysis and/or MDRD < 30 ml/min)
- Patients without a pre-hospital 12-lead ECG performed or available
- Patients suspicious of aortic dissection or pulmonary embolism
- Patients with confirmed AMI, PCI or CABG <30 days prior to inclusion
- Communication issues with patient/language barrier
- Decision of a present general practitioner to evaluate the patient at ER
- Decision of the consultant cardiologist to evaluate patient at the ER
irrespective of HEART score
- Any significant medical or mental condition, which in the Investigator*s
opinion may interfere with the patient*s optimal participation in the study
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL66755.091.18 |