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Trial registered on ANZCTR


Registration number
ACTRN12621000053820
Ethics application status
Approved
Date submitted
20/10/2020
Date registered
21/01/2021
Date last updated
21/01/2021
Date data sharing statement initially provided
21/01/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
SAMI: Validation of a high sensitivity troponin assay for the assessment of patient with suspected acute myocardial infarction
Scientific title
Evaluating the diagnostic accuracy of the Siemen’s Atellica high sensitivity troponin assay for assessment of patients with suspected acute myocardial infarction
Secondary ID [1] 302560 0
Nil known
Universal Trial Number (UTN)
U1111-1259-8421
Trial acronym
SAMI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Myocardial Infarction 319436 0
Suspected Acute Coronary Syndrome 319437 0
Condition category
Condition code
Cardiovascular 317407 317407 0 0
Coronary heart disease
Public Health 317408 317408 0 0
Health service research
Cardiovascular 317719 317719 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This study will evaluate the use of a highly sensitive troponin assay, the Siemens Atellica assay, for use across five Emergency Departments across Queensland Health. The study will identify the optimum metrics for safe and efficient evaluation rule out of Acute Myocardial Infarction (AMI) in emergency patients with symptoms suggestive of suspected Acute Coronary Syndrome (ACS).

For this study, eligible participants will be invited to consent to a small amount (approximately 10 mls) of additional blood being collected during standard care for the assessment of suspected ACS. The samples will be collected by venepuncture by an appropriately trained ED clinician (e.g. nurse or medical officer) and/or a Research Nurse on presentation and again at 2-3 hours post initial draw depending on local hospital protocol. The Research Nurse will also collect baseline demographic, cardiac risk factors and medical history data from the patient. The sample & data collection process is likely to take less than 30 minutes in total. Participation in the study will not change the ED assessment or care of the patient.

Additionally, some previously collected stored blood samples will be utilised for assessment of the assay. These samples were collected in the same manner described above.

As part of the consent process, participants may choose to allow their collected samples to be utilised for future research of new/novel troponin assays.
Intervention code [1] 318849 0
Diagnosis / Prognosis
Comparator / control treatment
N/A
Control group
Uncontrolled

Outcomes
Primary outcome [1] 325438 0
AMI including STEMI/NSTEMI.
This outcome will be determined by Cardiologist adjudication by reviewing participant's ECGs, HsTnI results, medical chart, and any cardiac test data (e.g. exercise stress test, angiogram, etc).
Timepoint [1] 325438 0
Within 30 days of initial presentation
Primary outcome [2] 325439 0
Cardiac Death (patients who die of a cardiac cause)
This outcome will be assessed by telephone follow up and data linkage to medical records within 30 days of initial presentation.
Timepoint [2] 325439 0
Within 30 days of initial presentation
Secondary outcome [1] 387966 0
Index T1MI
This outcome will be determined by Cardiologist adjudication by reviewing participant's ECGs, HsTnI results, medical chart, and any cardiac test data (e.g. exercise stress test, angiogram, etc) for index presentation.
Timepoint [1] 387966 0
On index presentation
Secondary outcome [2] 387967 0
Index T1 or T2MI
This outcome will be determined by Cardiologist adjudication by reviewing participant's ECGs, HsTnI results, medical chart, and any cardiac test data (e.g. exercise stress test, angiogram, etc) for index presentation
Timepoint [2] 387967 0
On index presentation
Secondary outcome [3] 387968 0
Type 1 MI
This outcome will be determined by Cardiologist adjudication by reviewing participant's ECGs, HsTnI results, medical chart, and any cardiac test data (e.g. exercise stress test, angiogram, etc) and subsequent presentations within 30 days.
Timepoint [3] 387968 0
Within 30 days of index presentation

Eligibility
Key inclusion criteria
Patients will be eligible for enrolment into the study if they are greater than or equal to 18 years old, the treating physician intends to investigate for ACS and a research nurse is available for recruitment. Patients will be identified by the research nurse using the Emergency Department databases (EDIS or First Net).
Minimum age
18 Years
Maximum age
100 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. There are initial ECG changes consistent with a ST segment elevation myocardial infarction (STEMI) and the patient bypasses the ED with direct transfer for percutaneous coronary intervention
2. Were transferred from another hospital
3. We previously enrolled in the trial within the past 30 days.
4. Are pregnant
5. Are unable to provide informed consent (e.g., language barriers)
6. Are unwilling to provide informed consent
7. Staff consider recruitment inappropriate (e.g., palliative patient)

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Diagnostic accuracy statistics (sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) will be calculated for each of the AMI outcomes. Sex specific 99th percentile cut-offs at 0 hours and at 0/2-3 hours will be used. In all instances, 95% confidence intervals will be adjusted for clustering of patients within hospitals.

Regression analyses will be used to identify the predicted probability of AMI across the range of troponin values. The sensitivity and NPV for each endpoint will also be calculated for all values below the 99th percentile.

Descriptive statistics and diagnostic accuracy statistics will be reported for the existing Queensland Health pathway. Further, there are a number of previously proposed pathways for the assessment of patients with suspected ACS. Each of these strategies include rule-out criteria, rule-in criteria and observational criteria. For each of the proposed strategies, sensitivity and NPV will be calculated for rule-out criteria and PPV and specificity will be calculated for rule-in criteria.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 18068 0
Gold Coast University Hospital - Southport
Recruitment hospital [2] 18069 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [3] 18070 0
Logan Hospital - Meadowbrook
Recruitment hospital [4] 18071 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [5] 18072 0
The Townsville Hospital - Douglas
Recruitment postcode(s) [1] 32056 0
4215 - Southport
Recruitment postcode(s) [2] 32057 0
4029 - Herston
Recruitment postcode(s) [3] 32058 0
4131 - Meadowbrook
Recruitment postcode(s) [4] 32059 0
4102 - Woolloongabba
Recruitment postcode(s) [5] 32060 0
4814 - Douglas

Funding & Sponsors
Funding source category [1] 306994 0
Hospital
Name [1] 306994 0
Pathology Queensland
Address [1] 306994 0
Level 5, Block 7,
Royal Brisbane and Women's Hospital
Butterfield Street, Herston, QLD, 4029
Country [1] 306994 0
Australia
Primary sponsor type
Hospital
Name
Royal Brisbane and Women's Hospital
Address
Emergency Trauma Centre,
Ground Floor, James Mayne Building,
Royal Brisbane and Women's Hospital,
Butterfield Street, Herston, QLD, 4029
Country
Australia
Secondary sponsor category [1] 307563 0
None
Name [1] 307563 0
None
Address [1] 307563 0
None
Country [1] 307563 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307126 0
RBWH Human Ethics Committee
Ethics committee address [1] 307126 0
Royal Brisbane & Women’s Hospital
Executive Suites, Lower Ground Floor
Dr James Mayne Building
Butterfield Street, Herston Qld 4029
Ethics committee country [1] 307126 0
Australia
Date submitted for ethics approval [1] 307126 0
18/06/2020
Approval date [1] 307126 0
19/08/2020
Ethics approval number [1] 307126 0
LNR/2020/QRBW/65773

Summary
Brief summary
Testing the clinical performance of hs-cTn assays from different manufacturers in the assessment of acute myocardial infarction is crucial. The Siemen’s Atellica hs-cTn assay has previously been evaluated using only two patient cohorts, one in
Scotland and one in the United States. Each of these evaluations tested a different strategy for ruling in and ruling out heart attack. As such, there is limited data available around how well this assay will be perform for a Queensland population of patients with suspected acute coronary syndrome.
We propose an observational study to evaluate the performance of the Siemen's Atellica hs-cTn assay. To complete this research, two sources of data will
be used. First, we will prospectively collect data from five Queensland Health sites. The data collected will include clinical data and a small amount of
additional blood taken during the routine blood test. Second, we will use existing blood samples stored as part of a previous research project. The
combined data will be used to identify the diagnostic accuracy of the Siemen's Atellica hs-cTnI assay for 30-day cardiac outcomes of AMI and cardiac
death in patients presenting to emergency departments.. We hypothesise that this study will identify an appropriate low level cut-off value for safe rule out of AMI on index presentation specific for this assay.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 106122 0
Prof Louise Cullen
Address 106122 0
Emergency Trauma Centre
Royal Brisbane and Women's Hospital
Butterfield Street, Herston, QLD, 4029
Country 106122 0
Australia
Phone 106122 0
+61 736468153
Fax 106122 0
Email 106122 0
Louise.Cullen@health.qld.gov.au
Contact person for public queries
Name 106123 0
Ms Laura Foran
Address 106123 0
Emergency Trauma Centre
Royal Brisbane and Women's Hospital
Butterfield Street, Herston, QLD, 4029
Country 106123 0
Australia
Phone 106123 0
+61 736466262
Fax 106123 0
Email 106123 0
laura.foran@health.qld.gov.au
Contact person for scientific queries
Name 106124 0
A/Prof Jaimi Greenslade
Address 106124 0
Emergency Trauma Centre
Royal Brisbane and Women's Hospital
Butterfield Street, Herston, QLD, 4029
Country 106124 0
Australia
Phone 106124 0
+61 736466262
Fax 106124 0
Email 106124 0
jaimi.greenslade@health.qld.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
No Results