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Pre-hospital Rule-out of Acute Coronary Syndrome (ARTICA)

Primary Purpose

Acute Coronary Syndrome

Status
Active
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Pre-hospital rule-out strategy
Sponsored by
Radboud University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Acute Coronary Syndrome focused on measuring Point-of-care troponin, HEART score, Acute Coronary Syndrome, Myocardial infarction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • RadboudUMC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Pre-hospital rule-out strategy

Emergency department rule-out strategy

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Safety: all cause death, acute coronary syndrome, unplanned revascularisation
Major adverse cardiac events (all cause death, ACS, unplanned revascularisation)
Costs from a societal perspective (all health effects and changes in resource use caused by an intervention)
Costs from a societal perspective are defined as the sum of the healthcare costs and the costs from productivity losses.
Safety (all cause death, acute coronary syndrome, unplanned revascularisation)
Major adverse cardiac events (all cause death, ACS, unplanned revascularisation)
Safety (all cause death, acute coronary syndrome, unplanned revascularisation)
Major adverse cardiac events (all cause death, ACS, unplanned revascularisation)

Full Information

First Posted
July 17, 2022
Last Updated
July 20, 2022
Sponsor
Radboud University Medical Center
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT05466591
Brief Title
Pre-hospital Rule-out of Acute Coronary Syndrome
Acronym
ARTICA
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
June 4, 2022 (Actual)
Study Completion Date
May 4, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Radboud University Medical Center
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome
Keywords
Point-of-care troponin, HEART score, Acute Coronary Syndrome, Myocardial infarction

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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).
Masking
InvestigatorOutcomes Assessor
Masking Description
The clinical events are blindly adjudicated by an independent Clinical Events Committee
Allocation
Randomized
Enrollment
866 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pre-hospital rule-out strategy
Arm Type
Experimental
Arm Description
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.
Arm Title
Emergency department rule-out strategy
Arm Type
No Intervention
Arm Description
According to standard care, the patients are immediately transported to the emergency department.
Intervention Type
Diagnostic Test
Intervention Name(s)
Pre-hospital rule-out strategy
Intervention Description
Point-of-care troponin measurement for pre-hospital rule-out of acute coronary syndrome
Primary Outcome Measure Information:
Title
Costs from a healthcare perspective (all costs related to healthcare consumption in-hospital, all outpatient visits including diagnostic tests and general practitioner consultations)
Description
Healthcare costs consist of all costs related to healthcare consumption
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Safety: all cause death, acute coronary syndrome, unplanned revascularisation
Description
Major adverse cardiac events (all cause death, ACS, unplanned revascularisation)
Time Frame
30 days
Title
Costs from a societal perspective (all health effects and changes in resource use caused by an intervention)
Description
Costs from a societal perspective are defined as the sum of the healthcare costs and the costs from productivity losses.
Time Frame
30 days
Title
Safety (all cause death, acute coronary syndrome, unplanned revascularisation)
Description
Major adverse cardiac events (all cause death, ACS, unplanned revascularisation)
Time Frame
6 months
Title
Safety (all cause death, acute coronary syndrome, unplanned revascularisation)
Description
Major adverse cardiac events (all cause death, ACS, unplanned revascularisation)
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Niels van Royen, MD PhD Prof
Organizational Affiliation
Radboud University Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
RadboudUMC
City
Nijmegen
ZIP/Postal Code
6525GA
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be available to researchers who were granted permission to the data by the principal investigator
IPD Sharing Time Frame
1 year after completion
IPD Sharing Access Criteria
After permission
Links:
URL
http://articatrial.nl/en/artica-2/
Description
Study website

Learn more about this trial

Pre-hospital Rule-out of Acute Coronary Syndrome

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