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Direct uitsluiten van het hartinfarct in de ambulance door afname van een vragenlijst en bepalen van een hartspecifieke eiwit

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 troponin. The ARTICA randomized trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON23618
Enrollment
866
Registered
2018-07-10
Start date
2019-01-03
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

chest pain, myocardial infarction, non-ST segment elevation acute coronary syndrome, troponin

Interventions

Pre-hospital triage with management by the General practitioner versus pre-hospital triage with standard referral to the hospital

Sponsors

Radboud university medical center, Department of Cardiology
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: - Age at least 18 years; male ánd female - All out-of-hospital patients with chest pain or symptoms suggestive of ACS initially visited by an ambulance with an indication for transfer to a hospital to evaluate and rule out ACS - Symptom duration for at least two hours - Modified HEAR(T) score less or equal than 3 - A point of care troponin below the upper reference limit (for patients stratified to prehospital management by the general practitioner) - The patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.

Exclusion criteria

Exclusion criteria: - Electrocardiographic ST-segment elevation - 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 <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 outcomes

Primary

MeasureTime frame
The primary endpoint consists of a significant reduction in health care costs at 30 days by a decrease in health care resources and use of ambulance

Secondary

MeasureTime frame
The secondary endpoint will determine the safety at one, six months and 12 months in major adverse cardiac events

Contacts

Public ContactCyril Camaro

Department of Cardiology, Radboudumc, Geert Grooteplein 10, 6525 GA Nijmegen, The Netherlands

cyril.camaro@radboudumc.nl+31 24 361 45 33

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)