Acute Coronary SyndromeARTICANCT05466591
Pre-hospital Rule-out of Acute Coronary Syndrome
A study testing Pre-hospital rule-out strategy in people with Acute Coronary Syndrome, run by Radboud University Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- Pre-hospital rule-out strategy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 866 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Mar 2019to 4 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- Pre-hospital rule-out strategy
- Keywords
- Point-of-care troponin, HEART score, Acute Coronary Syndrome, Myocardial infarction
- Medical subject headings
- Acute Coronary Syndrome, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-hospital rule-out strategyDiagnostic test
Point-of-care troponin measurement for pre-hospital rule-out of acute coronary syndrome
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 days
Secondary outcomes (4)
Safety: all cause death, acute coronary syndrome, unplanned revascularisation
Major adverse cardiac events (all cause death, ACS, unplanned revascularisation)
Measured: 30 days
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.
Measured: 30 days
Safety (all cause death, acute coronary syndrome, unplanned revascularisation)
Major adverse cardiac events (all cause death, ACS, unplanned revascularisation)
Measured: 6 months
Safety (all cause death, acute coronary syndrome, unplanned revascularisation)
Major adverse cardiac events (all cause death, ACS, unplanned revascularisation)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2022
- Study start1 Mar 2019
- Primary completion4 Jun 2022
- Study completion4 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 866 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Responsible party
- Principal investigator, Cyril Camaro, Radboud University Medical Center
- Investigators
- Niels van Royen, MD PhD Prof, Study chair, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05466591
- Sponsor's protocol ID
- NL 66755.091.18
- Other IDs
- NTR7346, NTR7346, 852001942
- Acronym
- ARTICA
- Status last verified
- Jul 2022
- First submitted
- 17 Jul 2022
- Last updated
- 25 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be available to researchers who were granted permission to the data by the principal investigator
Publications
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.
PubMed 38011992Camaro 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.
PubMed 36755110
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05466591
- Acronym / sponsor ID
- ARTICA / NL 66755.091.18
- Conditions
- Acute Coronary Syndrome
- Keywords
- Point-of-care troponin, HEART score, Acute Coronary Syndrome, Myocardial infarction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 866 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 4 Jun 2022 (actual)
- Study completion
- 4 May 2023 (estimated)
- First posted
- 20 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Pre-hospital rule-out strategy | Experimental | Diagnostic Test: Pre-hospital rule-out strategyPatients 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. |
| Emergency department rule-out strategy | No intervention | –According to standard care, the patients are immediately transported to the emergency department. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pre-hospital rule-out strategyPoint-of-care troponin measurement for pre-hospital rule-out of acute coronary syndrome | Diagnostic test | Pre-hospital rule-out strategy |
Primary outcome
Costs from a healthcare perspective (all costs related to healthcare consumption in-hospital, all outpatient visits including diagnostic tests and general practitioner consultations)
Time frame: 30 days
Healthcare costs consist of all costs related to healthcare consumption
4 secondary outcomes
Safety: all cause death, acute coronary syndrome, unplanned revascularisation
Time frame: 30 days
Costs from a societal perspective (all health effects and changes in resource use caused by an intervention)
Time frame: 30 days
Safety (all cause death, acute coronary syndrome, unplanned revascularisation)
Time frame: 6 months
Safety (all cause death, acute coronary syndrome, unplanned revascularisation)
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2022.
- Derived from this study: PubMed 38011992Aarts 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.
- Derived from this study: PubMed 36755110Camaro 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.
- Study websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Data will be available to researchers who were granted permission to the data by the principal investigator
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Niels van Royen, MD PhD Prof study chair
Radboud University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pre-hospital rule-out strategy in people with Acute Coronary Syndrome, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Costs from a healthcare perspective (all costs related to healthcare consumption in-hospital, all outpatient visits including diagnostic tests and general practitioner consultations) (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05466591, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2022.