Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001056189
Ethics application status
Approved
Date submitted
16/07/2019
Date registered
29/07/2019
Date last updated
21/06/2021
Date data sharing statement initially provided
29/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
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.
Scientific title
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.
Secondary ID [1] 298743 0
Nil known
Universal Trial Number (UTN)
U1111-1237-0598
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
acute myocardial infarction 313674 0
Condition category
Condition code
Cardiovascular 312087 312087 0 0
Coronary heart disease

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
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.
Intervention code [1] 315010 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 320732 0
A combined endpoint of cardiac mortality, new non-fatal acute myocardial infarction, or unplanned revascularization within 30 days. Myocardial infarction will include both Type 1 and type 2 myocardial infarction. This data will be collected from hospital records and through direct patient contact.
Timepoint [1] 320732 0
Thirty days post presentation to the Emergency Department
Secondary outcome [1] 372653 0
A combined endpoint of cardiac mortality, new non-fatal acute myocardial infarction, or unplanned revascularization within 30 days. Myocardial infarction will only include Type 1 myocardial infarction. This data will be collected from hospital records and through direct patient contact.
Timepoint [1] 372653 0
Thirty days post presentation to the Emergency Department
Secondary outcome [2] 372654 0
A combined endpoint of cardiac mortality, new non-fatal acute myocardial infarction, or unplanned revascularization during the index presentation. Myocardial infarction will only include Type 1 myocardial infarction. This data will be collected from hospital records and through direct patient contact.
Timepoint [2] 372654 0
During the index hospital admission.
Secondary outcome [3] 372656 0
A combined endpoint of cardiac mortality, new non-fatal acute myocardial infarction, or unplanned revascularization during the index presentation. Myocardial infarction will include Type 1 myocardial infarction and Type 2 myocardial infarction. This data will be collected from hospital records and through direct patient contact.
Timepoint [3] 372656 0
During the index hospital admission

Eligibility
Key inclusion criteria
Patients will be recruited if they were aged greater than or equal to 18 years and are undergoing investigation for potential ACS.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
For the assay to be accurate enough for early rule out, we require sensitivity >99%. Ninety-six patients with AMI are required to detect this level of sensitivity with 2% precision and confidence level of 95%. The AMI rate ranges from 5% to 20% across studies, with an average of 10%. Thus, the total required sample size is estimated at 960.

Baseline characteristics of the cohort will be reported using descriptive statistics. The primary analyses will examine the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) for primary endpoint at all troponin values below the 99th percentile. Regression analyses will also be used to identify the predicted probability of the primary outcome across the range of troponin values.

Secondary analyses will also examine the diagnostic accuracy (sensitivity, specificity, PPV and NPV) for each endpoint across the range of troponin values below the 99th percentile.

We will also utilise data collected in this study to report the costs associated with implementing an Abbott cTnI-Nx assay. This will include an estimate of the costs incurred in utilising the assay, along with the potential costs saved through hospital avoidance and reduced length of stay for patients that do ultimately present to the ED.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
12/08/2019
Actual
12/08/2019
Date of last participant enrolment
Anticipated
12/08/2020
Actual
28/05/2021
Date of last data collection
Anticipated
Actual
28/05/2021
Sample size
Target
960
Accrual to date
Final
960
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 14232 0
The Prince Charles Hospital - Chermside
Recruitment hospital [2] 14233 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 27225 0
4032 - Chermside
Recruitment postcode(s) [2] 27226 0
4029 - Herston

Funding & Sponsors
Funding source category [1] 303300 0
Commercial sector/Industry
Name [1] 303300 0
Abbott Point of Care
Country [1] 303300 0
United States of America
Primary sponsor type
Individual
Name
Louise Cullen
Address
Emergency and Trauma Centre, Royal Brisbane and Women's Hospital
Butterfield Street, Herston, QLD, 4006
Country
Australia
Secondary sponsor category [1] 303321 0
None
Name [1] 303321 0
Address [1] 303321 0
Country [1] 303321 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303831 0
Royal Brisbane and Women's Hospital Human Research Ethics Committee
Ethics committee address [1] 303831 0
Ethics committee country [1] 303831 0
Australia
Date submitted for ethics approval [1] 303831 0
05/12/2018
Approval date [1] 303831 0
09/01/2019
Ethics approval number [1] 303831 0
49262

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

Contacts
Principal investigator
Name 94966 0
Prof Louise Cullen
Address 94966 0
Emergency and Trauma Centre, Royal Brisbane and Women's Hospital
Butterfield Street, Herston, QLD, 4029
Country 94966 0
Australia
Phone 94966 0
+61 7 3646 8111
Fax 94966 0
Email 94966 0
[email protected]
Contact person for public queries
Name 94967 0
Louise Cullen
Address 94967 0
Emergency and Trauma Centre, Royal Brisbane and Women's Hospital
Butterfield Street, Herston, QLD, 4029
Country 94967 0
Australia
Phone 94967 0
+61 7 3646 8111
Fax 94967 0
Email 94967 0
[email protected]
Contact person for scientific queries
Name 94968 0
Louise Cullen
Address 94968 0
Emergency and Trauma Centre, Royal Brisbane and Women's Hospital
Butterfield Street, Herston, QLD, 4029
Country 94968 0
Australia
Phone 94968 0
+61 7 3646 8111
Fax 94968 0
Email 94968 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This study will use confidential patient information that can not be released without prior approval from Queensland Health.


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.