A study to asses if a new Point-of-Care test could potentially improve care for patients suspected of having a heart attack.

Improving care for possible myocardial infarction by determining the precision of a next generation i-STAT High Sensitivity Troponin-I point-of-care test in patients presenting with possible acute coronary syndrome in the emergency department

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12625000710426

Acronym

ICare-MI POC

Enrollment

1300

Registered

2025-07-04

Start date

2025-03-01

Completion date

2026-01-31

Last updated

2025-09-15

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

Conditions

None listed

Brief summary

Within the emergency department doctors use a blood test called "troponin" to determine if there is any damage to the heart muscle (possible heart attack). New generation tests can determine troponin concentrations to very low levels which allow doctors to use just one test and see that some patients are not having a heart attack (and potentially could go home). The latest generation of these tests can be performed at the bedside and get results in minutes instead of hours - meaning the diagnosis can be made quicker. Each manufacturer produces slightly different troponin numbers with their test. Before such a test can be used, we must determine that it measures troponin precisely enough and we must determine the threshold concentration below which doctors can be confident that patients are not having a heart attack. This is the purpose of this study.

Interventions

In patients within an emergency department being investigated for possible myocardial infarction an additional blood test will be performed with the i-STAT High Sensitivity Troponin-I (i-STAT hs-TnI) assay. The results will not be made available to attending physicians and will not be used in clinical care. Blood will be drawn by a researcher (nurse) and immediately assayed with the i-STAT hs-TnI. There is no other patient participation. Data from the medical record will be collected for 30 d

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Diagnosis

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

• Adults greater than or equal to 18 years of age. • A clinical cTn test is performed.

Exclusion criteria

• Died within ED. • Transfers from other hospitals. • More than 24 hours from symptom onset • No consent

Outcome results