NCT05466591

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
866

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2019

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 4, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 17, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 20, 2022

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 4, 2023

Completed
Last Updated

July 25, 2022

Status Verified

July 1, 2022

Enrollment Period

3.3 years

First QC Date

July 17, 2022

Last Update Submit

July 20, 2022

Conditions

Acute Coronary Syndrome

Keywords

Point-of-care troponinHEART scoreAcute Coronary SyndromeMyocardial infarction

Outcome Measures

Primary Outcomes (1)

  • Costs from a healthcare perspective (all costs related to healthcare consumption in-hospital, all outpatient visits including diagnostic tests and general practitioner consultations)

    Healthcare costs consist of all costs related to healthcare consumption

    30 days

Secondary Outcomes (4)

  • Safety: all cause death, acute coronary syndrome, unplanned revascularisation

    30 days

  • Costs from a societal perspective (all health effects and changes in resource use caused by an intervention)

    30 days

  • Safety (all cause death, acute coronary syndrome, unplanned revascularisation)

    6 months

  • Safety (all cause death, acute coronary syndrome, unplanned revascularisation)

    12 months

Study Arms (2)

Pre-hospital rule-out strategy

EXPERIMENTAL

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.

Diagnostic Test: Pre-hospital rule-out strategy

Emergency department rule-out strategy

NO INTERVENTION

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

Interventions

Pre-hospital rule-out strategyDIAGNOSTIC_TEST

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

Pre-hospital rule-out strategy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

RadboudUMC

Nijmegen, 6525GA, Netherlands

Location

Related Publications (2)

  • 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.

    PMID: 38011992DERIVED

  • 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.

    PMID: 36755110DERIVED

Related Links

MeSH Terms

Conditions

Acute Coronary SyndromeMyocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Niels van Royen, MD PhD Prof

    Radboud University Medical Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The clinical events are blindly adjudicated by an independent Clinical Events Committee
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 17, 2022

First Posted

July 20, 2022

Study Start

March 1, 2019

Primary Completion

June 4, 2022

Study Completion

May 4, 2023

Last Updated

July 25, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will share

Data will be available to researchers who were granted permission to the data by the principal investigator

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
1 year after completion
Access Criteria
After permission

Locations

NL(1)