Skip to content

Re-engineering the clinical approach to suspected cardiac chest pain assessment; extending chest pain research evidence to the pre-hospital setting, enabled by novel point of care high-sensitivity cardiac troponin I (hs-cTnI) and artificial intelligence.

Re-engineering the clinical approach to suspected cardiac chest pain assessment; extending chest pain research evidence to the pre-hospital setting, enabled by novel point of care hs-cTnI and artificial intelligence.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12622001088730
Acronym
RAPIDx AI-Prehospital
Enrollment
5000
Registered
2022-08-05
Start date
2023-03-27
Completion date
Unknown
Last updated
2022-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The phenomenon of ambulance ramping is a significant challenge to healthcare systems. Reducing the burden on emergency departments (ED) is imperative. In Australia, suspected cardiac chest pain represents nearly 1 million ED presentations annually, yet approximately 85% of these patients do not have acute coronary syndrome (ACS). The clinical work-up for these patients is laborious and inefficient, especially in low-risk individuals. This study will investigate whether we can safely reduce ED presentations by shifting the initial assessment of chest pain to an out-of-hospital setting. Making it possible for paramedics and general practitioners to assess chest pain with portable blood test devices and digital algorithms, which accurately categorise a patient’s risk of ACS, means low-risk patients can be directed to a Priority Care Centre instead of ED. Priority Care Centres provide community-based health care for patients with urgent but non-life-threatening conditions, who would otherwise be seeking a service from an Emergency Department. The objectives of the study are two-fold: 1. Evaluate the non-inferiority of a model of care initiated pre-hospital using point of care High-Sensitivity Troponin I and artificial intelligence (AI)-based decision-support compared with standard ED care. 2. Establish the cost effectiveness and define the funding approaches to support the sustainable implementation of a prehospital model of care for the effective assessment of chest pain and suspected ACS.

Interventions

The intervention proposes a new model of care for initial chest pain assessment, which uses portable heart-related blood tests (high sensitivity troponin I level) and digital algorithms to support decision-making. The intervention will be administered by paramedics and general practitioners. Point of Care (POC) high sensitivity troponin I will be taken promptly, ideally within the first 10 minutes of the paramedic/GP encounter, however this will not be protocolized as part of the clinical trial

The intervention proposes a new model of care for initial chest pain assessment, which uses portable heart-related blood tests (high sensitivity troponin I level) and digital algorithms to support decision-making. The intervention will be administered by paramedics and general practitioners. Point of Care (POC) high sensitivity troponin I will be taken promptly, ideally within the first 10 minutes of the paramedic/GP encounter, however this will not be protocolized as part of the clinical trial. The POC high sensitivity troponin I level, as well as key clinical characteristics such as age, gender, prior coronary disease, nature and location of symptoms, the presences or absence of clinical finding, coronary risk factors (such as most recent cholesterol level, hypertension, diabetes, smoking status and family history) and baseline ECG will be gathered and assimilated into an algorithm. The timing of the ECG may occur immediately before or after POC high sensitivity troponin I testing, and ideally within the first 10 minutes of the paramedic/GP encounter, however this will not be protocolized as part of the clinical trial. The algorithm will produce a predicated likelihood of 48 hour death, myocardial infarction (MI), pulmonary embolism (PE) and aortic dissection. This will be displayed within the mobile clinical interface (i.e. digital application). Access to the clinical interface will either be via phone, tablet, or similar digital device. Data entry to receive an algorithm output is expected to take no more than 5 minutes at most. This predicted outcome rate information will be presented to the patient. From this, the health care worker and patient will decide whether the patient goes to ED or a Priority Care Centre for further assessment. The following dispositions will be offered: • If the algorithm-determined likelihood of adverse event is 1.0% and the high sensitivity troponin result is NOT elevated, and the ECG is NOT considered abnormal: 1. Patients will have the choice between being transported to and assessed further at a priority care centre OR the emergency department. 2. Rapid access cardiac clinic may be considered. Provision of the clinic appointment must occur within 72 hours. Rapid access cardiac clinic appointment bookings will be facilitated by the priority care centre at the end of the encounter. • If the algorithm-determined likelihood of adverse event is >1.0% OR there is an elevated high sensitivity troponin level, OR an abnormal ECG: 1. Patients will be transported to the emergency department for further assessment Rapid access cardiac clinic: These clinics will be staffed by dedicated nursing and medical experts with cardiac training and/or expertise. Subsequent testing will be determined by the treating clinicians, but application of the National Institute for Health and Care Excellence (NICE) guidelines recommended. These guidelines make recommendations regarding functional or invasive coronary testing based on characterisation of chest pain and cardiovascular risk factors. Priority Care Centres provide community-based health care for patients with urgent but non-life-threatening conditions, who would otherwise be seeking a service from an Emergency Department. Priority Care Centres are led by experienced General Practitioners with additional care from specially trained acute care nurses. They are health care facility that can provide prompt, risk-appropriate care for those not requiring emergency care. A cardiac clinic refers to outpatient clinic led by a cardiologist. Rapid access refers to the ability to obtain an appointment in a short timeframe (e.g. 72 hours). These rapid access cardiac clinical provide opportunity for timely cardiovascular assessment for risk-appropriate cohorts of patients such as those with new chest pain. Monitoring of uptake and adherence of the intervention during the study will occur via data review of the digital application and comparative investigation within the health system data if needed.

Sponsors

Flinders University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Diagnosis
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Patients seeking care from out-of-hospital health providers will be considered eligible for analysis if they meet all of the following: a) Clinical features of chest pain or suspected acute coronary syndrome (ACS) as the principal cause in an out-of-hospital environment (as deemed by health service); and b) At least one high-sensitivity troponin assay is drawn; and c) Age of 18 years or older;

Exclusion criteria

Patients seeking care from out-of-hospital health providers will be considered ineligible for analysis if they meet any of the following: a) Have had an in-hospital assessment for suspected cardiac chest pain within 30 days; or b) Reside interstate or overseas; or c) Wish to opt-out.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026