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Trial registered on ANZCTR
Registration number
ACTRN12620000768998p
Ethics application status
Submitted, not yet approved
Date submitted
10/06/2020
Date registered
27/07/2020
Date last updated
27/07/2020
Date data sharing statement initially provided
27/07/2020
Type of registration
Prospectively registered
Titles & IDs
Public title
Assessment of Safety and Hospital Resource Utilisation of Emergency Department Initiated Computed Tomography Coronary Angiography (CTCA) in Intermediate Risk Acute Coronary Syndrome (ACS) Patients: a Randomised Controlled Trial
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Scientific title
Assessment of Safety and Hospital Resource Utilisation of Emergency Department Initiated Computed Tomography Coronary Angiography (CTCA) in Intermediate Risk Acute Coronary Syndrome (ACS) Patients: a Randomised Controlled Trial
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Secondary ID [1]
301469
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nil known
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Universal Trial Number (UTN)
U1111-1253-1602
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Trial acronym
SHRUED-CTCA
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Linked study record
N/A
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Health condition
Health condition(s) or problem(s) studied:
Acute Coronary Syndrome
317788
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Myocardial Infarction
317789
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Myocardial Injury
317804
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Condition category
Condition code
Cardiovascular
315851
315851
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0
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Coronary heart disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
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.
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Intervention code [1]
317782
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Diagnosis / Prognosis
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Comparator / control treatment
ARM 2 (control arm):
Participants randomly allocated to the control arm will receive the current standard of care. Participants will be seen by the on-call cardiology registrar within the context of a formal cardiology consult in ED. The cardiology registrar will determine and arrange appropriate investigation and all clinical management resulting from the investigation will be at clinician discretion.
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Control group
Active
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Outcomes
Primary outcome [1]
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ED length of stay will be compared between randomised arms, determined via administrative dataset and medical record interrogation.
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Assessment method [1]
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Timepoint [1]
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3 months and 12 months post enrolment.
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Primary outcome [2]
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Rates of admission will be compared between randomised arms, determined via administrative dataset and medical record interrogation.
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Assessment method [2]
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Timepoint [2]
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3 months and 12 months post enrolment.
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Primary outcome [3]
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Resource utilisation will be compared between randomised arms, determined via administrative dataset and medical record interrogation.
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Assessment method [3]
324065
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Timepoint [3]
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3 months and 12 months post enrolment.
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Secondary outcome [1]
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Clinical events (i.e. MACE and its components: death, myocardial infarction and coronary revacularization) within 3 months and 12 months will be presented as counts and the time to the first occurrence of the event. Time to the first occurrence of the clincial outcomes will be compared with log-rank tests.
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Assessment method [1]
383654
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Timepoint [1]
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3 months and 12 months post enrolment.
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
70
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Diagnosis
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment will be used for this trial, up to the point of participant randomisation.
Method of allocation is central randomisation by computer.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
4 x 4 block randomisation. Participants randomised 1:1 (standard care vs intervention).
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
Experience from the RAPID TnT study demonstrates that 308/1646 (19%) of patients with suspected ACS without obvious clinical ischaemia have a troponin profile that falls within the grey zone, and among these patients, the median total length of stay was 12 hours (interquartile range: 5.1-34.5hrs) [ED Mean length of stay 7.1 hrs (sd: 5.0 hrs)] and 7/308 (2.3%) experienced death or recurrent MI within 30 days. Therefore, with a power of 80% and a level of significance of 0.05, enrolling 100 participants per arm will enable the detection of a shortening of the ED length of stay by 2 hours. Therefore, this study will enroll n=200 patients.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
25/08/2020
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Actual
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Date of last participant enrolment
Anticipated
25/08/2021
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Actual
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Date of last data collection
Anticipated
25/08/2022
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Actual
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Sample size
Target
200
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
SA
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Recruitment hospital [1]
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The Royal Adelaide Hospital - Adelaide
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Recruitment postcode(s) [1]
30499
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5000 - Adelaide
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Funding & Sponsors
Funding source category [1]
305902
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Hospital
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Name [1]
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2020 CALHN CEO Clinical Rapid Implementation Project Scheme (CRIPS) - Royal Adelaide Hospital
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Address [1]
305902
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Royal Adelaide Hospital Research Fund
Royal Adelaide Hospital
Level 3
1 Port Road, Adelaide, SA 5000
Australia
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Country [1]
305902
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Australia
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Primary sponsor type
Hospital
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Name
The Royal Adelaide Hospital
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Address
Royal Adelaide Hospital
1 Port Road, Adelaide SA 5000
Australia
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
306365
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Country [1]
306365
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Ethics approval
Ethics application status
Submitted, not yet approved
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Ethics committee name [1]
306159
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Central Adelaide Local Health Network HREC
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Ethics committee address [1]
306159
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Royal Adelaide Hospital
1 Port Road Adelaide SA 5000
Australia
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Ethics committee country [1]
306159
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Australia
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Date submitted for ethics approval [1]
306159
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05/06/2020
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Approval date [1]
306159
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Ethics approval number [1]
306159
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Summary
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.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Cynthia Papendick
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Address
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Royal Adelaide Hospital
1 Port Road Adelaide SA 5000
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Country
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Australia
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Phone
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+61 456 572 263
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
102915
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Dr Cynthia Papendick
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Address
102915
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Royal Adelaide Hospital
1 Port Road Adelaide SA 5000
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Country
102915
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Australia
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Phone
102915
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+61 456 572 263
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Dr Cynthia Papendick
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Address
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Royal Adelaide Hospital
1 Port Road Adelaide SA 5000
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Country
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Australia
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Phone
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+61 456 572 263
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Fax
102916
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
Data may contain individual participant information that will not be readily de-identifiable. IPD sharing will be considered at a later stage.
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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