Acute rule out of non-ST segment elevation acute coronary syndrome in the (pre)hospital setting by HEART score assessment and a single point of care tropnin: the ARTICA randomized trial

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 866

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary aim of the study is the assessment of health care costs. Cost and<br /><br>quality adjusted life years (QALYs) will be measured on a per patient basis<br /><br>over the relevant time path in which the (most important) differences in both<br /><br>measures between both arms manifest themselves. Cost-effectiveness will be<br /><br>expressed in terms of cost per QALY gained.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary aim is to determine safety, as shown by previous studies i.e.<br /><br>major adverse cardiac events (MACE) less than 1.5% at one, six and 12 months.<br /><br>At last we will evaluate the potential improvement in patient care, both for<br /><br>patient convenience (by using questionnaires after 30 days of follow-up<br /><br>concerning the patient*s experience: direct reassurance for very low risk of<br /><br>NSTE ACS as for health care costs (no ambulance transfer and admittance to the<br /><br>ER).</p><br>