Pre-hospital Rule-out of Acute Coronary Syndrome

NCT ID: NCT05466591

Last Updated: 2022-07-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 866 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-01
• Study Completion Date: 2023-05-04

Brief Summary

Patients with chest pain suspected for non ST-segment elevation acute coronary syndrome (NSTE-ACS) are routinely transferred to the emergency department (ED). A point-of-care (POC) troponin measurement might enable ambulance paramedics to identify low-risk patients in whom ED evaluation is not necessary. The ARTICA trial aims to assess the healthcare cost reduction and safety of a pre-hospital rule-out strategy using a single POC troponin measurement.

Detailed Description

Patients with chest pain suspected of a NSTE-ACS are screened by ambulance paramedics. The HEAR score (HEART score without the Troponin component) is assessed and patients with a HEAR score of ≤3 are included. The patients are randomised to 1) pre-hospital rule-out with POC troponin measurement (intervention group) and 2) direct transfer to the ED (standard care group). Primary outcome is healthcare costs after 30 days.

Conditions

Acute Coronary Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: DOUBLE

Study Groups

Pre-hospital rule-out strategy

Patients undergo a point-of-care troponin T measurement. If troponin is low, an acute coronary syndrome is considered ruled-out and the care for the patient is transferred to the general practitioner. If troponin is elevated, the patient is immediately transported to the emergency department.

Group Type: EXPERIMENTAL

Pre-hospital rule-out strategy

Intervention Type: DIAGNOSTIC_TEST

Point-of-care troponin measurement for pre-hospital rule-out of acute coronary syndrome

Emergency department rule-out strategy

According to standard care, the patients are immediately transported to the emergency department.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Pre-hospital rule-out strategy

Point-of-care troponin measurement for pre-hospital rule-out of acute coronary syndrome

Intervention Type: DIAGNOSTIC_TEST

Eligibility 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 pre-hospital 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

• 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 Glascgow coma scale (GCS) <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 <90 mmHg and heart rate >100 beats per minute 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 glomular filtration rate (GFR) < 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 acute myocardial infarction, percutaneous coronary intervention or coronary artery bypass grafting <30 days prior to inclusion
• Communication issues with patient/language barrier
• Decision of a present general practitioner to evaluate the patient at the emergency department (ED)
• Decision of the consultant cardiologist to evaluate patient at the ER irrespective of HEART score
• Any significant medical or mental condition, which in the Investigators opinion may interfere with the patients optimal participation in the study

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ZonMw: The Netherlands Organisation for Health Research and Development

OTHER

Sponsor Role: collaborator

Radboud University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Cyril Camaro

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Niels van Royen, MD PhD Prof

Role: STUDY_CHAIR

Radboud University Medical Center

Locations

RadboudUMC

Nijmegen, , Netherlands

Countries

Netherlands

References

Aarts GWA, Camaro C, Rodwell L, Adang EMM, van Hout R, Brok G, Hoare A, de Pooter FPC, de Wit W, Cramer GE, van Kimmenade RRJ, Ouwendijk E, Rutten M, Zegers E, van Geuns RM, Gomes MER, Damman P, van Royen N. Differences in risk and costs between prehospital identified low-risk men and women with chest pain. Open Heart. 2023 Nov 27;10(2):e002390. doi: 10.1136/openhrt-2023-002390.

Reference Type: DERIVED

PMID: 38011992 (View on PubMed)

Camaro C, Aarts GWA, Adang EMM, van Hout R, Brok G, Hoare A, Rodwell L, de Pooter F, de Wit W, Cramer GE, van Kimmenade RRJ, Damman P, Ouwendijk E, Rutten M, Zegers E, van Geuns RM, Gomes MER, van Royen N. Rule-out of non-ST-segment elevation acute coronary syndrome by a single, pre-hospital troponin measurement: a randomized trial. Eur Heart J. 2023 May 14;44(19):1705-1714. doi: 10.1093/eurheartj/ehad056.

Reference Type: DERIVED

PMID: 36755110 (View on PubMed)

Related Links

http://articatrial.nl/en/artica-2/

Study website

Other Identifiers

NTR7346

Identifier Type: REGISTRY

Identifier Source: secondary_id

NTR7346

Identifier Type: REGISTRY

Identifier Source: secondary_id

852001942

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

NL 66755.091.18

Identifier Type: -

Identifier Source: org_study_id