SAMI: Validation of a high sensitivity troponin assay for the assessment of patient with suspected acute myocardial infarction

Conditions

None listed

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.

Louise Cullen, Jaimi Greenslade, Laura Stephensen, Isuru Ranasinghe, N. Gaikwad et al. (10 authors)

Emergency Medicine Journal2024-02-052 citations

10.1136/emermed-2023-213539

Personalized diagnosis in suspected myocardial infarction.

Neumann JT, Twerenbold R, Ojeda F, Aldous SJ, Allen BR, Apple FS, Babel H, Christenson RH, Cullen L, Di Carluccio E, Doudesis D, Ekelund U, Giannitsis E, Greenslade J, Inoue K, Jernberg T, Kavsak P, Keller T, Lee KK, Lindahl B, Lorenz T, Mahler SA, Mills NL, Mokhtari A, Parsonage W, Pickering JW, Pemberton CJ, Reich C, Richards AM, Sandoval Y, Than MP, Toprak B, Troughton RW, Worster A, Zeller T, Ziegler A, Blankenberg S, ARTEMIS study group.

2023-05-0220 citations

10.1007/s00392-023-02206-3

Interventions

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 addition

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.

Eligibility

Sex/Gender

All

Age

18 Years to 100 Years

Healthy volunteers

No

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).

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)

Outcome results