ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

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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

1/12/2021

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 high sensitivity troponin assay for assessment of patients with suspected acute myocardial infarction

Secondary ID [1]

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

Suspected Acute Coronary Syndrome

Condition category

Condition code

Cardiovascular

Coronary heart disease

Public Health

Health service research

Cardiovascular

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]

Diagnosis / Prognosis

Comparator / control treatment

N/A

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

Within 30 days of initial presentation

Primary outcome [2]

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]

Within 30 days of initial presentation

Secondary outcome [1]

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]

On index presentation

Secondary outcome [2]

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]

On index presentation

Secondary outcome [3]

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]

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

Sex

Both males and females

Can healthy volunteers participate?

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

Completed

Date of first participant enrolment

Anticipated

Actual

17/11/2020

Date of last participant enrolment

Anticipated

30/05/2021

Actual

9/09/2021

Date of last data collection

Anticipated

30/06/2021

Actual

31/10/2021

Sample size

Target

1890

Accrual to date

Final

2022

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment hospital [1]

Gold Coast University Hospital - Southport

Recruitment hospital [2]

Royal Brisbane & Womens Hospital - Herston

Recruitment hospital [3]

Logan Hospital - Meadowbrook

Recruitment hospital [4]

Princess Alexandra Hospital - Woolloongabba

Recruitment hospital [5]

The Townsville Hospital - Douglas

Recruitment postcode(s) [1]

4215 - Southport

Recruitment postcode(s) [2]

4029 - Herston

Recruitment postcode(s) [3]

4131 - Meadowbrook

Recruitment postcode(s) [4]

4102 - Woolloongabba

Recruitment postcode(s) [5]

4814 - Douglas

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Pathology Queensland

Address [1]

Level 5, Block 7,
Royal Brisbane and Women's Hospital
Butterfield Street, Herston, QLD, 4029

Country [1]

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]

None

Name [1]

None

Address [1]

None

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

RBWH Human Ethics Committee

Ethics committee address [1]

Royal Brisbane & Women’s Hospital
Executive Suites, Lower Ground Floor
Dr James Mayne Building
Butterfield Street, Herston Qld 4029

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

18/06/2020

Approval date [1]

19/08/2020

Ethics approval number [1]

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

Prof Louise Cullen

Address

Emergency Trauma Centre
Royal Brisbane and Women's Hospital
Butterfield Street, Herston, QLD, 4029

Country

Australia

Phone

+61 736468153

Fax

Louise.Cullen@health.qld.gov.au

Contact person for public queries

Name

Laura Foran

Address

Emergency Trauma Centre
Royal Brisbane and Women's Hospital
Butterfield Street, Herston, QLD, 4029

Country

Australia

Phone

+61 736466262

Fax

laura.foran@health.qld.gov.au

Contact person for scientific queries

Name

Jaimi Greenslade

Address

Emergency Trauma Centre
Royal Brisbane and Women's Hospital
Butterfield Street, Herston, QLD, 4029

Country

Australia

Phone

+61 736466262

Fax

jaimi.greenslade@health.qld.gov.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

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

Source	Title	Year of Publication	DOI
Dimensions AI	Single High-Sensitivity Point-of-Care Whole-Blood Cardiac Troponin I Measurement to Rule Out Acute Myocardial Infarction at Low Risk	2022	https://doi.org/10.1161/circulationaha.122.061148

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

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Documents added manually

Documents added automatically