Trial Review

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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
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
Secondary ID [1] 301469 0
nil known
Universal Trial Number (UTN)
U1111-1253-1602
Trial acronym
SHRUED-CTCA
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Acute Coronary Syndrome 317788 0
Myocardial Infarction 317789 0
Myocardial Injury 317804 0
Condition category
Condition code
Cardiovascular 315851 315851 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 317782 0
Diagnosis / Prognosis
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.
Control group
Active

Outcomes
Primary outcome [1] 324062 0
ED length of stay will be compared between randomised arms, determined via administrative dataset and medical record interrogation.
Timepoint [1] 324062 0
3 months and 12 months post enrolment.
Primary outcome [2] 324064 0
Rates of admission will be compared between randomised arms, determined via administrative dataset and medical record interrogation.
Timepoint [2] 324064 0
3 months and 12 months post enrolment.
Primary outcome [3] 324065 0
Resource utilisation will be compared between randomised arms, determined via administrative dataset and medical record interrogation.
Timepoint [3] 324065 0
3 months and 12 months post enrolment.
Secondary outcome [1] 383654 0
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.
Timepoint [1] 383654 0
3 months and 12 months post enrolment.

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
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
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.
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).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
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.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
25/08/2020
Actual
Date of last participant enrolment
Anticipated
25/08/2021
Actual
Date of last data collection
Anticipated
25/08/2022
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 16854 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 30499 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 305902 0
Hospital
Name [1] 305902 0
2020 CALHN CEO Clinical Rapid Implementation Project Scheme (CRIPS) - Royal Adelaide Hospital
Country [1] 305902 0
Australia
Primary sponsor type
Hospital
Name
The Royal Adelaide Hospital
Address
Royal Adelaide Hospital
1 Port Road, Adelaide SA 5000
Australia
Country
Australia
Secondary sponsor category [1] 306365 0
None
Name [1] 306365 0
Address [1] 306365 0
Country [1] 306365 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 306159 0
Central Adelaide Local Health Network HREC
Ethics committee address [1] 306159 0
Ethics committee country [1] 306159 0
Australia
Date submitted for ethics approval [1] 306159 0
05/06/2020
Approval date [1] 306159 0
Ethics approval number [1] 306159 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 102914 0
Dr Cynthia Papendick
Address 102914 0
Royal Adelaide Hospital
1 Port Road Adelaide SA 5000
Country 102914 0
Australia
Phone 102914 0
+61 456 572 263
Fax 102914 0
Email 102914 0
cynthia.papendick@sa.gov.au
Contact person for public queries
Name 102915 0
Cynthia Papendick
Address 102915 0
Royal Adelaide Hospital
1 Port Road Adelaide SA 5000
Country 102915 0
Australia
Phone 102915 0
+61 456 572 263
Fax 102915 0
Email 102915 0
cynthia.papendick@sa.gov.au
Contact person for scientific queries
Name 102916 0
Cynthia Papendick
Address 102916 0
Royal Adelaide Hospital
1 Port Road Adelaide SA 5000
Country 102916 0
Australia
Phone 102916 0
+61 456 572 263
Fax 102916 0
Email 102916 0
cynthia.papendick@sa.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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.


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.