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Use of a single Abbott point of care blood test for rule out of heart attack in patients presenting to the Emergency Department with chest pain.

Use of a single Abbott point of care high sensitivity troponin assay for rule out of acute myocardial infarction in patients presenting to the Emergency Department with symptoms of acute coronary syndrome.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12619001056189
Enrollment
960
Registered
2019-07-29
Start date
2019-08-12
Completion date
2021-05-28
Last updated
2021-06-28

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

Conditions

None listed

Brief summary

Acute chest pain is one of most common causes for visits to emergency department (ED) throughout the world. It represents around 5% of all ED visits. Current processes to rule-out acute myocardial infarction (AMI) in the ED are inefficient, costly, and place burden on a system that is already under considerable strain from overcrowding and a lack of resources. Strategies that reduce the number of patients presenting to ED with chest pain and strategies to streamline the assessment of the patients who arrive at ED are urgently required. In this study, we will evaluate a strategy to identify patients who do not need extensive investigation (including serial troponin testing) for possible AMI. We seek to rapidly rule-out AMI using the Abbott cTnI-Nx assay. This point of care assay could ultimately be utilised in the pre-hospital environment (including health clinics or in the primary care setting), or in the ED setting. The goal is to realise a safe assessment method that is patient focussed, avoids hospital presentations, provides value based care, minimises patient risk and reduces ED overcrowding. This is an observational study. Patients will be treated as per standard care. For patients who consent to participate, an additional sample of blood will be taken at the same time as bloods are taken for standard care. This blood will be frozen and stored in the Emergency Department. This blood will later be thawed and analysed using the new Abbott cTnI-Nx assay. The accuracy of this assay for the diagnosis of AMI will be assessed.

Interventions

This study will investigate a point of care high sensitivity troponin assay for the assessment of patients who present to the Emergency Department with symptoms suspicious for acute coronary syndrome. This new assay has been developed by Abbott point of care and is referred to as the Abbott cTnI-Nx assay. In standard care, emergency clinicians (nurses or doctors) take blood from patients with symptoms suspicious for acute coronary syndrome as soon as possible after presentation. This blood is u

This study will investigate a point of care high sensitivity troponin assay for the assessment of patients who present to the Emergency Department with symptoms suspicious for acute coronary syndrome. This new assay has been developed by Abbott point of care and is referred to as the Abbott cTnI-Nx assay. In standard care, emergency clinicians (nurses or doctors) take blood from patients with symptoms suspicious for acute coronary syndrome as soon as possible after presentation. This blood is utilised for the the assessment of cardiac troponin. In this study, the emergency clinician will continue this procedure, but will also take an additional volume of blood. This additional blood will be sent to the central laboratory for centrifuge and freezing at -80 degrees. After enrolment of all participants is complete, these frozen blood samples will later thawed and batch analysed by the central hospital laboratory using the Abbott cTnI-Nx assay. We will be taking additional blood (15ml) for the investigation of the Abbott cTnI-Nx assay once for each patient (on presentation). This blood will be taken while the patient is in the Emergency Department. The patient care will not be altered by this blood draw. All patients will undergo standard care as per the guidelines in place within their emergency department.

Sponsors

Louise Cullen
Lead SponsorIndividual

Eligibility

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

Inclusion criteria

Patients will be recruited if they were aged greater than or equal to 18 years and are undergoing investigation for potential ACS.

Exclusion criteria

Patients will be excluded if: 1) There are initial ECG changes consistent with a ST segment elevation myocardial infarction (STEMI) 2) they were transferred from another hospital 3) They are unable or unwilling to consent

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026