Trial Review

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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12625000710426
Ethics application status
Approved
Date submitted
16/12/2024
Date registered
4/07/2025
Date last updated
4/07/2025
Date data sharing statement initially provided
4/07/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
A study to asses if a new Point-of-Care test could potentially improve care for patients suspected of having a heart attack.
Scientific title
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
Secondary ID [1] 313527 0
None
Universal Trial Number (UTN)
Trial acronym
ICare-MI POC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Coronary Syndrome 335970 0
Acute Myocardial Infarction 336278 0
Condition category
Condition code
Cardiovascular 332556 332556 0 0
Other cardiovascular diseases
Emergency medicine 332557 332557 0 0
Other emergency care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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 days.
Intervention code [1] 330104 0
Early detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 340074 0
Major adverse cardiac event (MACE) rate per presentation within 30 days for patients discharged directly from ED and the rates for each individual component of MACE. MACE is defined as: (1) cardiac death (adjudicated) OR (2) Acute Myocardial Infarction (AMI): ST-segment Elevation Myocardial Infarction (STEMI), Non-ST-segment Elevation Myocardial Infarction (NSTEMI), Type 1 and Type 2 (adjudicated)
Timepoint [1] 340074 0
30 days post test.
Secondary outcome [1] 443777 0
Death
Timepoint [1] 443777 0
At 30 days.
Secondary outcome [2] 444857 0
Possible adverse reactions are bruising at the site of blood draw.
Timepoint [2] 444857 0
Within the index ED presentation

Eligibility
Key inclusion criteria
• Adults greater than or equal to 18 years of age.
• A clinical cTn test is performed.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Died within ED.
• Transfers from other hospitals.
• More than 24 hours from symptom onset
• No consent

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Multiple methods will be used to determine a low-risk threshold for myocardial infarction with this assay. The point estimate of the sensitivity for this threshold must be >= 99%.
The proportion less than the low-risk threshold will be determined for efficacy.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/03/2025
Date of last participant enrolment
Anticipated
31/01/2026
Actual
Date of last data collection
Anticipated
31/01/2027
Actual
Sample size
Target
2000
Accrual to date
973
Final
Recruitment outside Australia
Country [1] 26772 0
New Zealand
State/province [1] 26772 0

Funding & Sponsors
Funding source category [1] 317981 0
Commercial sector/Industry
Name [1] 317981 0
Abbott Point of Care
Country [1] 317981 0
United States of America
Primary sponsor type
Hospital
Name
Christchurch Hospital
Address
Country
New Zealand
Secondary sponsor category [1] 320323 0
None
Name [1] 320323 0
Address [1] 320323 0
Country [1] 320323 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316651 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 316651 0
Ethics committee country [1] 316651 0
New Zealand
Date submitted for ethics approval [1] 316651 0
01/05/2024
Approval date [1] 316651 0
18/06/2024
Ethics approval number [1] 316651 0
URB/06/12/093

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 138538 0
Prof Martin Than
Address 138538 0
Canterbury District Health Board and Emergency Care Foundation 21 Taylors Mistake Road Sumner Christchurch 8081
Country 138538 0
New Zealand
Phone 138538 0
+64 3 326 7599
Fax 138538 0
Email 138538 0
[email protected]
Contact person for public queries
Name 138539 0
Martin Than
Address 138539 0
Canterbury District Health Board and Emergency Care Foundation 21 Taylors Mistake Road Sumner Christchurch 8081
Country 138539 0
New Zealand
Phone 138539 0
+64 3 326 7599
Fax 138539 0
Email 138539 0
[email protected]
Contact person for scientific queries
Name 138540 0
Professor John Pickering
Address 138540 0
c/- Emergency Care Foundation P O Box 13-149 Christchurch 8140
Country 138540 0
New Zealand
Phone 138540 0
+64 21 2537877
Fax 138540 0
Email 138540 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: These patients are undergoing routine clinical investigation and it is not appropriate to make the results publicly available.



What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.