Improving the Accuracy of Referrals of Patients With Chest Pain (URGENT2)

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.

Study Overview

• Status: Recruiting
• Conditions: Myocardial Infarction; Myocardial Ischemia; Chest Pain; Acute Coronary Syndrome; Heart Attack
• Intervention / Treatment: Diagnostic test: modified HEART score (including POC hs cTnI analysis); Other: Standard care and triage according to the local (EMT)protocol.

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 Type: Interventional
• Enrollment (Anticipated): 852
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lisa Frenk, Drs.; Phone Number: 0031773205555; Email: lfrenk@viecuri.nl

Study Locations

• Netherlands
  • Limburg
    • Roermond, Limburg, Netherlands, 6043 CV
      • Recruiting
      • Laurentius Hospital Roermond
      • Contact: Cees de Vos, Dr.
    • Venlo, Limburg, Netherlands, 5912 BL
      • Recruiting
      • Viecuri Medical Centre Northern Limburg
      • Contact: Braim Rahel, Dr.
      • Contact: Joan Meeder, dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; 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.	Diagnostic test: 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.
Active Comparator: Control group; Chest pain patients in the control group will receive standard triage and standard care according to the local (EMT) protocol.	Other: Standard care and triage according to the local (EMT)protocol.; Standard care and triage of chest pain patients according to the local (EMT)protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	30 days, 6 months and 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	30 days
Clinical accuracy POC hs cTnI.	Clinical accuracy (Positive Predictive value) of POC hs cTnI assessment versus hs cTnT at the cardiac ED.	30 days
Time analysis.	Time elapsed from arrival EMT at patient's home to arrival at ED in intervention group versus control group.	30 days

Collaborators and Investigators

• Sponsor: VieCuri Medical Centre
• Collaborators: Siemens Healthineers Nederland B.V.
• Investigators: Principal Investigator: Braim Rahel, Dr., Viecuri Medical Centre Northern Limburg; Principal Investigator: Joan Meeder, Dr., Viecuri Medical Centre Northern Limburg; Principal Investigator: Cees de Vos, Dr., Laurentius Hospital Roermond; Study Director: Robert Willemsen, Dr., General practitioner office Nazareth Maastricht

Study record dates

Study Major Dates

• Study Start (Actual): July 4, 2021
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): June 1, 2024

Study Registration Dates

• First Submitted: May 11, 2021
• First Submitted That Met QC Criteria: May 21, 2021
• First Posted (Actual): May 27, 2021

Study Record Updates

• Last Update Posted (Actual): June 10, 2022
• Last Update Submitted That Met QC Criteria: June 9, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Troponin; Point-of-care testing; Modified HEART score; Siemens Healthineers
• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Myocardial Infarction; Infarction; Myocardial Ischemia; Ischemia; Chest Pain; Acute Coronary Syndrome
• Other Study ID Numbers: Study number 2021_002; NL71820.096.19 (Other Identifier: Toetsingonline/CCMO)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No