None listed
Conditions
Brief summary
Chest pain is the second most common presenting complaint to emergency departments and Acute Coronary Syndromes (ACS) are a high risk differential diagnosis in this group. As per the NHF guidelines the standard work up of ACS is a risk stratification process which aims to separate patients into low, high or intermediate risk categories. The diagnostic process for determining risk is resource-intensive, currently inefficient and of extremely low yield. 25% of patients assessed for suspected ACS in the emergency department (ED) are categorised as“intermediate risk” , i.e they neither “rule in” or “rule out” for ACS at their index visit in ED and require further testing to determine if they are high- or low- risk. Locally the Royal Adelaide Hospital (RAH) currently investigates this intermediate cohort with cardiology review in ED to arrange for further testing either as a cardiology inpatient or for follow up in specialised OPD clinic as the necessary tests are not available from ED. This multistep process is complicated, associated with delays to diagnosis, is resource intensive and low yield in confirming ACS. On August 3, 2020, SA Health will launch high sensitivity reporting which will increase the number of patients who fall into this intermediate category with potential significant stress to the system. A method to more accurately determine which patients can be managed without cardiology input has the potential to significantly decrease the resource burden of this process, whilst also improving patient convenience and satisfaction. The primary hypothesis is that ED-initiated CTCA will decrease resource utilisation, in terms of ED length of stay and cardiac testing, compared to current standard of care in ED patients with suspected ACS with indeterminate high sensitivity troponin results.
Interventions
Patients who are fall into the intermediate/grey zone risk for Acute Coronary Syndrome will be assessed for eligibility for this trial, consented appropriately and then randomised into one of two treatment arms:
ARM 1 (Intervention arm)
Those enrolled in the intervention arm will have a CTCA initiated by the ED, and the CTCA must occur within 72 hours of randomisation. The results of the CTCA will be provided to the Chief Investigator for review and arrangement of referral as appropriate (e.g.
Patients who are fall into the intermediate/grey zone risk for Acute Coronary Syndrome will be assessed for eligibility for this trial, consented appropriately and then randomised into one of two treatment arms: ARM 1 (Intervention arm) Those enrolled in the intervention arm will have a CTCA initiated by the ED, and the CTCA must occur within 72 hours of randomisation. The results of the CTCA will be provided to the Chief Investigator for review and arrangement of referral as appropriate (e.g. Cardiology OPD, General Practitioner or ED), or discussion with appropriate clinical teams where results are equivocal. Regarding how the Chief Investigator will determine follow up arrangements, results of the CTCA will be discussed with Cardiology as appropriate to facilitate appropriate decision making. Regarding the monitoring of intervention fidelity, the staff involved in enrolling participants are involved in the participants' clinical care and thus ensure appropriate study arrangements are followed. This process will be supported by data linkage. All eligibility and randomisation data will be sourced data verified, with additional data quality control performed via 10% of source data verification.
Sponsors
The Royal Adelaide Hospital
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 70 Years
Healthy volunteers
No
Inclusion criteria
Patients will be eligible for enrolment into the study if they meet all of the following criteria upon presentation to the ED: a) Symptoms of suspected ACS; b) Grey Zone values for high sensitivity troponin T (hs-cTnT)*; c) 18-70 years of age; d) Weight is <150kg; e) Have an eGFR >40ml/min; f) Willing and able to give written informed consent. *Initial troponin of <12ng/L and change of 3-4ng/L in 1 hour OR initial troponin between 13-51ng/L and a change of <5ng/L after 1 hour
Exclusion criteria
Patients will be excluded from the study if they meet any of the following criteria upon presentation to the ED: a) Presence of ST segment elevation on presenting ECG or other overtly ischaemic ECG changes b) Presence of arrhymthia on presenting ECG c) Have contraindications to CTCA including: a. Pregnancy b. Contrast allergy d) Life expectancy of less than 12 months e) Residing interstate or overseas
Outcome results
None listed