Clinical trial NCT04904107: Improving the Accuracy of Referrals of Patients With Chest Pain
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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chest Pain
Acute Coronary Syndrome
Myocardial Infarction
Myocardial Ischemia
Heart Attack
Keywords: Modified HEART score
Point-of-care testing
Troponin
Siemens Healthineers
Lead sponsor: VieCuri Medical Centre
Sponsor class: OTHER
Collaborators: name: Siemens Healthineers Nederland B.V.
First posted: 2021-05-27
Enrollment: 852
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: DIAGNOSTIC

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The incidence of non-cardiac chest pain (NCCP) patients admitted at the cardiac ED (percentage, %)
timeFrame: 30 days
measure: The incidence of MACE (percentage, %)
timeFrame: 30 days, 6 months and 1 year
Secondary outcomes:
measure: The incidence of MACE in subgroups (percentage, %)
timeFrame: 30 days, 6 months and 1 year
measure: The incidence of non-cardiac chest pain (NCCP) patients admitted at the cardiac ED in subgroups (percentage, %)
timeFrame: 30 days, 6 months and 1 year
measure: Cost-effectiveness analysis
timeFrame: 30 days, 6 months and 1 year
measure: Assessment of the diagnostic value of the modified HEART score.
timeFrame: 30 days, 6 months and 1 year
measure: Overview of the actual diagnosis of patients with a low modified HEART score (0-3).
timeFrame: 30 days
measure: Overview of the actual diagnosis of patients with moderate-high modified HEART score (>3).
timeFrame: 30 days
measure: Clinical accuracy POC hs cTnI.
timeFrame: 30 days
measure: Time analysis.
timeFrame: 30 days
Other outcomes:
Locations:
city: Roermond
country: Netherlands
facility: Laurentius Hospital Roermond
state: Limburg
city: Venlo
country: Netherlands
facility: Viecuri Medical Centre Northern Limburg
state: Limburg
Study officials:
affiliation: Viecuri Medical Centre Northern Limburg
name: Braim Rahel, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Viecuri Medical Centre Northern Limburg
name: Joan Meeder, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Laurentius Hospital Roermond
name: Cees de Vos, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Zuyderland MC
name: Arnoud van 't Hof, Prof. dr.
role: STUDY_DIRECTOR
affiliation: General practitioner office Nazareth Maastricht
name: Robert Willemsen, Dr.
role: STUDY_DIRECTOR
References: