None listed
Conditions
Brief summary
High sensitivity troponin assays have led to increased numbers of patients presented to the emergency department (ED) for suspected acute coronary syndrome (ACS) now having detectable troponin levels. For those with low level troponin elevated, there is limited evidence to guide care. It is suggested that individuals in this zone, have a higher risk of poor outcomes and the risk versus benefit of invasive coronary angiography (ICA) is less clear as the likelihood of an evolving heart attack is lower. Computed tomography coronary angiography (CTCA), being a less invasive alternate approach, may provide useful information to inform subsequent care to these lower risk patients. This randomised clinical trial aims to investigate CTCA vs. ICA in suspected ACS with low level troponin elevations in the ED. Outcomes will be assessed at 30 days and 12 months. A pilot study will be performed initially until greater funding can be sourced.
Interventions
The intervention is an alternate anatomical assessment of the coronary arteries via computer tomography coronary angiography (CTCA) for the low-intermediate risk participant based on high sensitivity troponin sampling. CTCA will be be performed as soon as feasible from randomisation, which be conducted routinely (and for which standard procedural consent will occur). The results of the CTCA will routinely be available to doctors/clinical care team for review, with guidance provided to the treating team regarding subsequent revascularisation based on CTCA findings. Care however will be ultimately at clinician discretion. a) The whole CTCA procedure including the preparatory work should take approx. 2 hours for a regular patient (the scan itself should take about 15-20min). However it may take additional hour if the patient is having difficulties with the heart rate control. b) The patient's doctor /clinical care team would be the one ensuring that the participant adheres to the intervention. The research team would work closely with doctors/clinical care team to ensure the strategies are implemented as well as appropriate study arrangements are followed.
Sponsors
Flinders University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Diagnosis
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients presenting to the emergency department will be considered eligible for analysis if they meet all of the following: a) Age of 18 years or older b) Presenting with symptoms suggestive of ACS; c) Troponin elevation above the 99th percentile URL but less than 5x URL d) Willing and able to give written informed consent
Exclusion criteria
Patients presenting to the ED will be considered ineligible for analysis if they meet any of the following: a) Ongoing chest pain and/or dynamic ST segment changes on ECG; b) Haemodynamic instability; c) Known coronary artery disease; d) High-risk features and/or deemed unsuitable for angiography, including: i. Renal dysfunction (eGFR less than 60mL/min/1.73m2); ii. Contrast allergy; iii. Atrial fibrillation; iv. Intolerance to beta blockers; v. Limited life expectancy, dementia or chronic liver disease; vi. Pregnancy. e) Reside overseas; f) Has language barrier preventing informed consent to participate in the trial
Outcome results
None listed