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

Not Applicable

Completed

• Conditions: Acute Myocardial Infarction; Suspected Acute Coronary Syndrome; Cardiovascular - Coronary heart disease; Public Health - Health service research; Cardiovascular - Other cardiovascular diseases

• Registration Number: ACTRN12621000053820
• Lead Sponsor: Royal Brisbane and Women's Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-01-21
• Study Completion: 2021-10-31
• Last Update Posted: 6 December 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 2022

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)

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
AMI including STEMI/NSTEMI.<br>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).[Within 30 days of initial presentation];Cardiac Death (patients who die of a cardiac cause)<br>This outcome will be assessed by telephone follow up and data linkage to medical records within 30 days of initial presentation. [Within 30 days of initial presentation]

Secondary Outcome Measures

Name	Time	Method
Index T1MI<br>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.[On index presentation];Index T1 or T2MI<br>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[On index presentation];Type 1 MI<br>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.[Within 30 days of index presentation]