Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000224820
Ethics application status
Approved
Date submitted
23/12/2020
Date registered
3/03/2021
Date last updated
7/04/2024
Date data sharing statement initially provided
3/03/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
'The Effect of Computed Tomography on Rates of Invasive Coronary Angiography in Acute Coronary Syndrome (CRITICAL-ACS)
Scientific title
'The Effect of Computed Tomography on Rates of Invasive Coronary Angiography in Acute Coronary Syndrome (CRITICAL-ACS)
Secondary ID [1] 303067 0
none
Universal Trial Number (UTN)
Trial acronym
CRITICAL ACS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Coronary Syndrome 320135 0
Condition category
Condition code
Cardiovascular 318076 318076 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Computed tomography coronary angiography (CTCA) takes about 20 minutes.
100mls of liquid contrast medium is injected into a vein (usually in the arm) to allow the inside and outside structure of blood vessels to be clearly visible on the CT angiogram images. This is the first coronary imaging modality followed by invasive coronary angiography as required according to the treating clinician with access to the CTCA findings.
Intervention code [1] 319350 0
Diagnosis / Prognosis
Comparator / control treatment
Standard care with invasive coronary angiography (ICA) as first coronary imaging modality. ICA is performed in a procedure room (or cath lab) by a cardiologist. A catheter is inserted into an artery (usually in the arm) and threaded up into the heart. 100mls of contrast dye is then sent through the catheter to help the arteries show up on an X-ray. The procedure takes about half an hour.
Control group
Active

Outcomes
Primary outcome [1] 326063 0
Requirement for inpatient invasive coronary angiography (ICA). as assessed from patient medical records.
Timepoint [1] 326063 0
During index hospital admission
Secondary outcome [1] 390005 0
Requirement for inter-hospital transfer as assessed from patient medical records.
Timepoint [1] 390005 0
During index hospital admission
Secondary outcome [2] 390006 0
Time from randomisation to definitive coronary imaging (CTCA or ICA) as assessed from patient medical records.
Timepoint [2] 390006 0
Either time of CTCA (if only required test) or time of ICA (in control arm or if ICA required in intervention arm)
Secondary outcome [3] 390007 0
The length of time spent in hospital from randomisation to discharge as assessed from patient medical records.
Timepoint [3] 390007 0
upon patient discharge
Secondary outcome [4] 390008 0
Inpatient coronary revascularization (Coronary Artery Bypass Graft or Percutaneous Coronary Intervention as assessed from patient medical records.
Timepoint [4] 390008 0
During index hospital admission
Secondary outcome [5] 390009 0
Death or rehospitalisation for any cause as assessed by patient medical record review
Timepoint [5] 390009 0
within 30 days after randomisation
Secondary outcome [6] 390010 0
Death, or rehospitalisation for any cause as assessed by patient medical record review
Timepoint [6] 390010 0
within 360 days after randomisation

Eligibility
Key inclusion criteria
1) Admission with presumed diagnosis of ACS with either or both of:
• ECG changes indicating new ischaemia,
• Rise and/or fall in troponin
2) Invasive coronary angiography planned
3) New Zealand resident
4) Age greater than or equal to 18 years
5) Provision of written informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Clinician-determined requirement for urgent (<24 hours) coronary angiography due to clinical instability
2) Prior coronary revascularisation
3) Ineligibility for CTCA or ICA according to local hospital practice
4) Severe chronic kidney disease (eGFR <30 mL/min/1.73m2)
5) Prior recruitment to trial
6) Known pregnancy or currently breast feeding

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)
central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software stratified allocation by hospital type – onsite Percutaneous Coronary Intervention (PCI) vs no onsite PCI, and sex
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The primary endpoint of proportion requiring invasive coronary angiography will be compared between randomised groups using a Mantel Haenszel Chi-square test utilising the design stratification factors.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/04/2022
Actual
19/04/2022
Date of last participant enrolment
Anticipated
28/02/2025
Actual
Date of last data collection
Anticipated
31/12/2030
Actual
Sample size
Target
700
Accrual to date
280
Final
Recruitment outside Australia
Country [1] 23345 0
New Zealand
State/province [1] 23345 0

Funding & Sponsors
Funding source category [1] 307474 0
Government body
Name [1] 307474 0
Health Research Council of New Zealand
Country [1] 307474 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
PO Box 56 Dunedin 9054 New Zealand.
Country
New Zealand
Secondary sponsor category [1] 308151 0
None
Name [1] 308151 0
Address [1] 308151 0
Country [1] 308151 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307550 0
Southern Health & Disability Ethics Committee
Ethics committee address [1] 307550 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 307550 0
New Zealand
Date submitted for ethics approval [1] 307550 0
13/04/2021
Approval date [1] 307550 0
27/08/2021
Ethics approval number [1] 307550 0
21/NTA/101

Summary
Brief summary
The Computed tomography to Reduce InTerventIonal Coronary Angiography and Length of stay in Acute Coronary Syndrome (CRITICAL-ACS) Study is a prospective, open-label, multi-centre, pragmatic randomised clinical trial that will compare the strategy of CTCA first versus standard care with ICA amongst patients admitted with presumed ACS.
Recruitment is planned to occur over 3 years with follow-up of 1 year after randomisation to allow the primary study to be completed in 4 years. At all stages, final management decisions will be left to the discretion of the treating clinician.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 107638 0
Dr Philip Adamson
Address 107638 0
Department of Medicine. University of Otago, Christchurch. PO Box 4345. Christchurch 8014.
Country 107638 0
New Zealand
Phone 107638 0
+64 3 3640640
Fax 107638 0
+64 3 364 1115
Email 107638 0
[email protected]
Contact person for public queries
Name 107639 0
Lorraine Skelton
Address 107639 0
Department of Medicine. University of Otago, Christchurch. PO Box 4345. Christchurch 8014.
Country 107639 0
New Zealand
Phone 107639 0
+64 3 3641063
Fax 107639 0
+64 3 364 1115
Email 107639 0
[email protected]
Contact person for scientific queries
Name 107640 0
Philip Adamson
Address 107640 0
Department of Medicine. University of Otago, Christchurch. PO Box 4345. Christchurch 8014.
Country 107640 0
New Zealand
Phone 107640 0
+64 3 3640640
Fax 107640 0
+64 3 364 1115
Email 107640 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
individual participant data of published results only
When will data be available (start and end dates)?
Immediately following publication, no end date
Available to whom?
case-by-case basis at the discretion of the Trial Management Group
Available for what types of analyses?
only to achieve the aims in the approved proposal
How or where can data be obtained?
access subject to approvals by Principal Investigator ([email protected])


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
SourceTitleYear of PublicationDOI
EmbaseRole of computed tomography cardiac angiography in acute chest pain syndromes.2023https://dx.doi.org/10.1136/heartjnl-2022-321360
N.B. These documents automatically identified may not have been verified by the study sponsor.