Re-engineering the clinical approach to suspected cardiac chest pain assessment; extending chest pain research evidence to the pre-hospital setting, enabled by novel point of care high-sensitivity cardiac troponin I (hs-cTnI) and artificial intelligence.
- Conditions
- Acute Coronary SyndromesCardiovascular - Coronary heart diseaseEmergency medicine - Other emergency care
- Registration Number
- ACTRN12622001088730
- Lead Sponsor
- Flinders University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 5000
Patients seeking care from out-of-hospital health providers will be considered eligible for analysis if they meet all of the following:
a)Clinical features of chest pain or suspected acute coronary syndrome (ACS) as the principal cause in an out-of-hospital environment (as deemed by health service); and
b)At least one high-sensitivity troponin assay is drawn; and
c)Age of 18 years or older;
Patients seeking care from out-of-hospital health providers will be considered ineligible for analysis if they meet any of the following:
a)Have had an in-hospital assessment for suspected cardiac chest pain within 30 days; or
b)Reside interstate or overseas; or
c)Wish to opt-out.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome will be the composite endpoint comprising of:<br>-Cardiovascular mortality<br>-New or recurrent Types 1, 3, 4, 5 MI defined by the current 4th Universal Definition of Myocardial Infarction (or latest iteration if subsequent iteration released).<br>-Pulmonary Embolus (PE) as defined by pulmonary artery filling defects documented on a CT pulmonary angiogram or mismatched ventilation/perfusion defects on a nuclear VQ scan.<br>-Aortic dissection as defined by an intimal breach of the aortic within its thoracic or abdominal course as documented on either CT, MRI or transoesophageal echocardiography.<br><br>This data will be obtained by data-linkage of clinical and administrative public and private hospital and health service data, births deaths and marriages and Medicare and PBS data, where applicable. <br><br>N.B All MIs PEs and Aortic Dissections diagnosed within 12 hours presentation to either a PCC or ED will be excluded from the primary outcome. <br>[30 days post-index presentation]
- Secondary Outcome Measures
Name Time Method