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
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.
Show all 11Show fewer
- 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