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

VieCuri Medical Centre

Status: Enrolling

Conditions: Myocardial Ischemia; Acute Coronary Syndrome; Heart Attack; Chest Pain; Myocardial Infarction

Treatments: Other: Standard care and triage according to the local (EMT)protocol.; Diagnostic Test: modified HEART score (including POC hs cTnI analysis)

Study type: Interventional

Funder types: Other

Identifiers

NCT04904107

Study number 2021_002

NL71820.096.19 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 852 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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852 participants in 2 patient groups

Intervention group

Experimental group

Description:

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.

Treatment:

Diagnostic Test: modified HEART score (including POC hs cTnI analysis)

Control group

Active Comparator group

Description:

Chest pain patients in the control group will receive standard triage and standard care according to the local (EMT) protocol.

Treatment:

Other: Standard care and triage according to the local (EMT)protocol.