Chest PainURGENT2NCT04904107
Improving the Accuracy of Referrals of Patients With Chest Pain
A study testing modified HEART score (including POC hs cTnI analysis) in people with Chest Pain and Acute Coronary Syndrome, run by VieCuri Medical Centre at 2 sites in Netherlands.
Trial summary
This is a multicenter, prospective, investigator-initiated, randomized controlled trial aiming to reduce the percentage of non-cardiac chest pain (NCCP) patients admitted to the cardiac emergency department (ED) by performing the modified HEART score by emergency medical transport (EMT) personnel. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chest Pain, Acute Coronary Syndrome, Myocardial Infarction
- What is being tested?
- modified HEART score (including POC hs cTnI analysis)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 852 participants
- Where
- 2 sitesNetherlands
- Study dates
- 4 Jul 2021to 3 Mar 2026
- 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 ≥ 18 years.
- Chest pain or other complaints suspect of ACS for at least 2 hours where the GP or emergency medical personnel are in need of further diagnostics or risk stratification to come to a decision of referral.
- Patients, who have been informed of the nature of the study, agree to its provisions and have provided written informed consent.
Who cannot join
- Electrocardiographic ST-segment elevation/High suspicion of STE-ACS.
- Suspicion of an acute non-coronary diagnosis e.g. pulmonary embolism, thoracic aortic dissection or other life-threatening disease.
- Patients presenting cardiogenic shock, defined as: systolic blood pressure <90mmHg and heart rate >100 and peripheral oxygen saturation <90% (without oxygen administration)
- Patients presenting with sudden onset heart rhythm disorders and second or third degree atrioventricular block.
- Patients with confirmed ACS, PCI or CABG <30 days prior to inclusion.
- Impaired consciousness defined as an EMV <8.
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- Severe shortness of breath.
- Patients with known end-stage renal disease (dialysis and/or MDRD < 30 ml/min).
- Patients with known cognitive impairment.
- Communication issues with patient/language barrier.
- Patients already participating in an interventional cardiology or cardiovascular trial.
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Laurentius Hospital Roermond
Roermond, Limburg, 6043 CV
Viecuri Medical Centre Northern Limburg
Venlo, Limburg, 5912 BL
About this study
Official title: A Multicentre Randomized Controlled Trial to Improve the accUracy of Referrals to the emerGency departmEnt of patieNts With chesT Pain by Using the Modified HEART Score in Emergency Medical Transport (URGENT 2.0)
This is a multicenter, prospective, investigator-initiated, randomized controlled trial aiming to reduce the percentage of non-cardiac chest pain (NCCP) patients admitted to the cardiac emergency department (ED) by performing the modified HEART score by emergency medical transport (EMT) personnel.
Read the detailed description
Patients with acute coronary syndrome (ACS) should be referred to the hospital promptly. However, referring all patients with chest pain is not feasible, as recent studies showed that up to 80% of the patients with acute chest pain do not have ACS.
Bedside point-of-care (POC) high sensitive troponin testing (in fingerprick blood/capillary blood) and the modified HEART score have become available and might play a substantial role in the triage and diagnosis of chest pain patients in a pre-hospital setting by general practitioners (GPs) and EMT personnel in the future. We hypothesize that patients with chest pain can be referred more accurately by using the modified HEART score.
- Conditions
- Chest Pain, Acute Coronary Syndrome, Myocardial Infarction, Myocardial Ischemia, Heart Attack
- Being tested
- modified HEART score (including POC hs cTnI analysis), Standard care and triage according to the local (EMT)protocol.
- Keywords
- Modified HEART score, Point-of-care testing, Troponin, Siemens Healthineers
- Medical subject headings
- Chest Pain, Acute Coronary Syndrome, Myocardial Infarction, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
modified HEART score (including POC hs cTnI analysis)Diagnostic test
The modified HEART score was developed in 2007 and has been validated to stratify the risk of short-term adverse cardiac events in patients with chest pain at the ED. Negative predictive value (NPV) of the modified HEART score for ACS as well as positive predictive value (PPV) for major adverse cardiac events (MACE) within 6 weeks after presentation is high.
The modified HEART score is an acronym for history, ECG, age, risk factors and troponin at arrival.The components can be rated 0,1 or 2 points each and result in a total score between 0 and 10.
Standard care and triage according to the local (EMT)protocol.Other
Standard care and triage of chest pain patients according to the local (EMT)protocol.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Chest pain patients in the intervention group will be assessed by EMT personnel by performing the modified HEART score (including POC high sensitive troponin-I measurement (POC HS cTnI)) and the referral policy depends on the result.
* In case of a low modified HEART score (modified HEART 0-3) patients will not be referred to the cardiac ED.
* Patients with a modified HEART score >3 are directly referred to the cardiac ED after evaluation. These patients will receive standard care. Receives: Diagnostic Test: modified HEART score (including POC hs cTnI analysis) |
| Control group | Active comparator | Chest pain patients in the control group will receive standard triage and standard care according to the local (EMT) protocol. Receives: Other: Standard care and triage according to the local (EMT)protocol. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of non-cardiac chest pain (NCCP) patients admitted at the cardiac ED (percentage, %)
Evaluation of the percentage of NCCP patients admitted to the cardiac ED by performing the modified HEART score in comparison to our control group (regular triage and care). We aim to detect a reduction of minimal 10% in unnecessarily referred chest pain patients (NCCP patients) but expect an even higher percentage. A lower percentage of NCCP patients indicates improval of the triage of chest pain patients.
Measured: 30 days
The incidence of MACE (percentage, %)
The mortality and major adverse cardiovascular events (MACE) i.e. acute myocardial infarction, non-elective percutaneous coronary intervention, coronary artery bypass grafting or all cause death within 30 days, 6 months and 1 year after initial presentation in the intervention group versus control group.
We aim that the proportion of MACE in the intervention group (modified HEART score) is non-inferior to the control group (regular care and triage). Preliminary results of the second phase of FAMOUS Triage trial showed 15.7% (13.1-18.6) MACE rate.We used the expected incidence of 15.7% as the point estimate (meaning no difference between control and intervention). A higher MACE rate (%) in the intervention group suggests a worst outcome.
Measured: 30 days, 6 months and 1 year
Secondary outcomes (8)
The incidence of MACE in subgroups (percentage, %)
Prespecified subgroup analyses of primary outcomes will be performed for:
- Diabetic patients versus non-diabetic patients.
- Male versus female patients
- Patients referred by GP versus patient referred by triage nurse at GP cooperatives (GPC) versus self referrals.
Measured: 30 days, 6 months and 1 year
The incidence of non-cardiac chest pain (NCCP) patients admitted at the cardiac ED in subgroups (percentage, %)
Prespecified subgroup analyses of primary outcomes will be performed for:
- Diabetic patients versus non-diabetic patients.
- Male versus female patients
- Patients referred by GP versus patient referred by triage nurse at GP cooperatives (GPC) versus self referrals.
Measured: 30 days, 6 months and 1 year
Cost-effectiveness analysis
This economic evaluation investigates the health care costs of full implementation of a prehospital rule- out strategy with the modified HEART score (intervention group) compared with regular care and standard transfer to the hospital to rule out ACS (control group). Health-care costs will be prospectively recorded at baseline and at 30 days follow-up, 6 months and 1 year. This includes health care costs due to readmission, diagnostic testing, revascularization etc. The cost of hospital treatment is determined by the Dutch Diagnose Behandel Combinatie (DBC) hospital reimbursement system and the DBC information system, similar to the international diagnosis related group system.
Measured: 30 days, 6 months and 1 year
Assessment of the diagnostic value of the modified HEART score.
Positive Predictive Value (PPV), sensitivity, specificity and Negative Predictive Value (NPV) of the modified HEART score for ACS will be calculated.
Measured: 30 days, 6 months and 1 year
Overview of the actual diagnosis of patients with a low modified HEART score (0-3).
To evaluate the percentage of patients in this specific group with ACS versus no-ACS.
Measured: 30 days
Overview of the actual diagnosis of patients with moderate-high modified HEART score (>3).
To evaluate the percentage of patients in this specific group with ACS versus no-ACS.
Measured: 30 days
Clinical accuracy POC hs cTnI.
Clinical accuracy (Positive Predictive value) of POC hs cTnI assessment versus hs cTnT at the cardiac ED.
Measured: 30 days
Time analysis.
Time elapsed from arrival EMT at patient's home to arrival at ED in intervention group versus control group.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2021
- Study start4 Jul 2021
- Primary completion3 Mar 2026
- Study completion3 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chest PainStudies of the same condition, open and under way.
- 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
- It concerns an investigator initiated prospective 1:1 randomised clinical trial in chest pain patients in a pre-hospital setting. Patients will be randomised to (A, intervention group) a direct assessment of the modified HEART score (including POC high sensitive troponin measurement) by EMT personnel and refrainment of transport to the cardiac emergency department (ED) in cases of a low score or (B, control group) regular triage and hospital evaluation, taking place at the cardiac ED in the majority of cases.
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 852 participants (actual)
Sponsor and investigators
- Lead sponsor
- VieCuri Medical Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Siemens Healthineers
- Responsible party
- Sponsor
- Investigators
- Braim Rahel, Dr., Principal investigator, Viecuri Medical Centre Northern LimburgJoan Meeder, Dr., Principal investigator, Viecuri Medical Centre Northern LimburgCees de Vos, Dr., Principal investigator, Laurentius Hospital RoermondArnoud van 't Hof, Prof. dr., Study director, Zuyderland MCRobert Willemsen, Dr., Study director, General practitioner office Nazareth Maastricht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04904107
- Sponsor's protocol ID
- Study number 2021_002
- Other IDs
- NL71820.096.19
- Acronym
- URGENT2
- Status last verified
- Oct 2026
- First submitted
- 11 May 2021
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Frenk LDS, Rahel BM, de Vos CB, van Osch FHM, Prestigiacomo FG, Janssen MJW, Willemsen RTA, van 't Hof AW, Meeder JG. Improving the accUracy of Referrals to the emerGency departmEnt of patieNts with chesT pain using the modified HEART score in Emergency Medical Transport (URGENT 2.0): protocol for a multicentre randomised controlled trial. BMJ Open. 2024 Dec 20;14(12):e084139. doi: 10.1136/bmjopen-2024-084139.
PubMed 39806626
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre Randomized Controlled Trial to Improve the accUracy of Referrals to the emerGency departmEnt of patieNts With chesT Pain by Using the Modified HEART Score in Emergency Medical Transport (URGENT 2.0)
- ClinicalTrials.gov ID
- NCT04904107
- Acronym / sponsor ID
- URGENT2 / Study number 2021_002
- Conditions
- Chest Pain, Acute Coronary Syndrome, Myocardial Infarction, Myocardial Ischemia, Heart Attack
- Keywords
- Modified HEART score, Point-of-care testing, Troponin, Siemens Healthineers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 852 participants (actual)
- Lead sponsor
- VieCuri Medical CentreUniversity, hospital or other
- Collaborators
- Siemens Healthineers
- Study start
- 4 Jul 2021 (actual)
- Primary completion
- 3 Mar 2026 (actual)
- Study completion
- 3 Mar 2026 (actual)
- First posted
- 27 May 2021 (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.
This is a multicenter, prospective, investigator-initiated, randomized controlled trial aiming to reduce the percentage of non-cardiac chest pain (NCCP) patients admitted to the cardiac emergency department (ED) by performing the modified HEART score by emergency medical transport (EMT) personnel.
Detailed description
Patients with acute coronary syndrome (ACS) should be referred to the hospital promptly. However, referring all patients with chest pain is not feasible, as recent studies showed that up to 80% of the patients with acute chest pain do not have ACS.
Bedside point-of-care (POC) high sensitive troponin testing (in fingerprick blood/capillary blood) and the modified HEART score have become available and might play a substantial role in the triage and diagnosis of chest pain patients in a pre-hospital setting by general practitioners (GPs) and EMT personnel in the future. We hypothesize that patients with chest pain can be referred more accurately by using the modified HEART score.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
- Model description
- It concerns an investigator initiated prospective 1:1 randomised clinical trial in chest pain patients in a pre-hospital setting. Patients will be randomised to (A, intervention group) a direct assessment of the modified HEART score (including POC high sensitive troponin measurement) by EMT personnel and refrainment of transport to the cardiac emergency department (ED) in cases of a low score or (B, control group) regular triage and hospital evaluation, taking place at the cardiac ED in the majority of cases.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Diagnostic Test: modified HEART score (including POC hs cTnI analysis)Chest pain patients in the intervention group will be assessed by EMT personnel by performing the modified HEART score (including POC high sensitive troponin-I measurement (POC HS cTnI)) and the referral policy depends on the result. * In case of a low modified HEART score (modified HEART 0-3) patients will not be referred to the cardiac ED. * Patients with a modified HEART score >3 are directly referred to the cardiac ED after evaluation. These patients will receive standard care. |
| Control group | Active comparator | Other: Standard care and triage according to the local (EMT)protocol.Chest pain patients in the control group will receive standard triage and standard care according to the local (EMT) protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years.
- Chest pain or other complaints suspect of ACS for at least 2 hours where the GP or emergency medical personnel are in need of further diagnostics or risk stratification to come to a decision of referral.
- Patients, who have been informed of the nature of the study, agree to its provisions and have provided written informed consent.
Key exclusion criteria (11 listed)
- Electrocardiographic ST-segment elevation/High suspicion of STE-ACS.
- Suspicion of an acute non-coronary diagnosis e.g. pulmonary embolism, thoracic aortic dissection or other life-threatening disease.
- Patients presenting cardiogenic shock, defined as: systolic blood pressure <90mmHg and heart rate >100 and peripheral oxygen saturation <90% (without oxygen administration)
- Patients presenting with sudden onset heart rhythm disorders and second or third degree atrioventricular block.
- Patients with confirmed ACS, PCI or CABG <30 days prior to inclusion.
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 |
|---|---|---|
| modified HEART score (including POC hs cTnI analysis)The modified HEART score was developed in 2007 and has been validated to stratify the risk of short-term adverse cardiac events in patients with chest pain at the ED. Negative predictive value (NPV) of the modified HEART score for ACS as well as positive predictive value (PPV) for major adverse cardiac events (MACE) within 6 weeks after presentation is high. The modified HEART score is an acronym for history, ECG, age, risk factors and troponin at arrival.The components can be rated 0,1 or 2 points each and result in a total score between 0 and 10. | Diagnostic test | Intervention group |
| Standard care and triage according to the local (EMT)protocol.Standard care and triage of chest pain patients according to the local (EMT)protocol. | Other | Control group |
Primary outcome
The incidence of non-cardiac chest pain (NCCP) patients admitted at the cardiac ED (percentage, %)
Time frame: 30 days
Evaluation of the percentage of NCCP patients admitted to the cardiac ED by performing the modified HEART score in comparison to our control group (regular triage and care). We aim to detect a reduction of minimal 10% in unnecessarily referred chest pain patients (NCCP patients) but expect an even higher percentage. A lower percentage of NCCP patients indicates improval of the triage of chest pain patients.
The incidence of MACE (percentage, %)
Time frame: 30 days, 6 months and 1 year
The mortality and major adverse cardiovascular events (MACE) i.e. acute myocardial infarction, non-elective percutaneous coronary intervention, coronary artery bypass grafting or all cause death within 30 days, 6 months and 1 year after initial presentation in the intervention group versus control group. We aim that the proportion of MACE in the intervention group (modified HEART score) is non-inferior to the control group (regular care and triage). Preliminary results of the second phase of FAMOUS Triage trial showed 15.7% (13.1-18.6) MACE rate.We used the expected incidence of 15.7% as the point estimate (meaning no difference between control and intervention). A higher MACE rate (%) in the intervention group suggests a worst outcome.
8 secondary outcomes
The incidence of MACE in subgroups (percentage, %)
Time frame: 30 days, 6 months and 1 year
The incidence of non-cardiac chest pain (NCCP) patients admitted at the cardiac ED in subgroups (percentage, %)
Time frame: 30 days, 6 months and 1 year
Cost-effectiveness analysis
Time frame: 30 days, 6 months and 1 year
Assessment of the diagnostic value of the modified HEART score.
Time frame: 30 days, 6 months and 1 year
Overview of the actual diagnosis of patients with a low modified HEART score (0-3).
Time frame: 30 days
Overview of the actual diagnosis of patients with moderate-high modified HEART score (>3).
Time frame: 30 days
Clinical accuracy POC hs cTnI.
Time frame: 30 days
Time analysis.
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Derived from this study: PubMed 39806626Frenk LDS, Rahel BM, de Vos CB, van Osch FHM, Prestigiacomo FG, Janssen MJW, Willemsen RTA, van 't Hof AW, Meeder JG. Improving the accUracy of Referrals to the emerGency departmEnt of patieNts with chesT pain using the modified HEART score in Emergency Medical Transport (URGENT 2.0): protocol for a multicentre randomised controlled trial. BMJ Open. 2024 Dec 20;14(12):e084139. doi: 10.1136/bmjopen-2024-084139.
- Individual participant dataSharing planned: No
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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.
Braim Rahel, Dr. principal investigator
Viecuri Medical Centre Northern Limburg
Joan Meeder, Dr. principal investigator
Viecuri Medical Centre Northern Limburg
Cees de Vos, Dr. principal investigator
Laurentius Hospital Roermond
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing modified HEART score (including POC hs cTnI analysis) in people with Chest Pain and Acute Coronary Syndrome, run by VieCuri Medical Centre at 2 sites 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 3 inclusion and 11 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: finished, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The incidence of non-cardiac chest pain (NCCP) patients admitted at the cardiac ED (percentage, %) (time frame: 30 days). The study lists 2 primary outcomes in all. 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 NCT04904107, which also lists 1 linked publication.
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 9 Oct 2026.