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

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 - ARTICA randomized trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON49843

Enrollment

866

Registered

2018-11-27

Start date

2019-03-02

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hartaandoeningen, non ST elevatie acuut coronair syndroom en pijn op de borst chest pain and non ST-segment elevation acute coronary syndrome

Interventions

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

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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 100 and peripheral oxygen saturation

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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).	—

Measure

Time frame

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).

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)