"chest pain" undifferentiated chest pain
Conditions
Interventions
Subjects with undifferentiated chest pain will be randomized between two
different care arms. In the intervention arm, subjects will be evaluated with
additional information provided by a support to
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patients above 17years old, Patients with undifferentiated chest discomfort Ability to communicate in Dutch or English
Exclusion criteria
Exclusion criteria: Communication barrier (e.g. language, understanding), ST-segment elevation myocardial infarction (electrocardiogram on scene is standard workup), Any obvious etiology for the symptoms requiring direct treatment (e.g. trauma), Being previously evaluated by EMS for the same complaint (already considered for participation) High clinical suspicion of a life-threating condition (e.g. sudden death survivor, hypothermia, shock, aortic dissection, hypoxia or intoxication), Cognitive impairment, End-stage renal disease, Pregnancy, Inability or unwillingness to provide informed consent, Not registered with a GP (huisarts).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main study parameter/endpoint a) Unexpected Serious Adverse Events (USAE) at 3 and 30 days from the index contact. An USAE is defined as any unexpected and undesired medical occurrence that: • Results in death • Is life-threatening • Requires (prolonged) hospitalization • Results in persistent or significant disability or incapacity • Any other important medical event that did not result in any of the outcomes listed above due to medical or surgical intervention but could have been avoided upon appropriate judgment by the investigator. USAE do not include events that are diagnosed during the index EMS contact. For example, the suspicion of a life-threatening diagnosis (e.g. myocardial infarction, aortic dissection, pulmonary embolism) at the initial EMS contact which resulted into conveyance to the ED where this life-threatening diagnosis was confirmed shall not be considered an USAE (as it was not unexpected). However, when a life-threatening diagnosis was not suspected at initial contact and the patient was left at home but at a later stage the diagnosis was established it will be considered an USAE. Also, a hospitalization based on the decision to transport a patient to the hospital is not USAE. Hospitalization after an initial decision to leave a patient at home is an USAE. Prolonged hospitalization due to any complications of treatment (e.g. invasive coronary angiography) is an USAE. A (re) transportation from the ED to an alternative hospital due to the need of PCI facilities is considered an USAE. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary study parameters/endpoints a) Unexpected Serious Adverse Events (USAE) at 6 months and 1 year from the index contact b) Unexpected Major Adverse Cardiac Event (UMACE) at 3 days, 30 days, 6 months and 1 year after index contact. UMACE is defined as: • Cardiac death • Myocardial infarction (9) • Invasive coronary angiography without revascularization • Revascularization with PCI • Revascularization with coronary artery bypass graft (CABG) c) Cumulative healthcare-related costs/resource (according to the Health Care Insurance Board-determined costs per treatment package [DBC]) at 3 days, 30 days, 6 months and 1 year of the index contact, including: • Ambulance personnel (EMS) evaluation and transport • ED costs • In-hospital workup and treatments • GP (huisarts) evaluation and treatment d) Quality of life at 3 days, 30 days, 6 months and 1 year of the index contact evaluated through the EuroQol 5D-5D-5L (completed through the dedicated phone or tablet app)15 Tertiary parameter/endpoint a) Percentage of included cases with a discordant (non-)conveyance decision between the preHEART algorithm and the effective management selected in the preHEART arm of the study | — |
Countries
Netherlands
Outcome results
None listed