Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001316796
Ethics application status
Approved
Date submitted
4/10/2022
Date registered
11/10/2022
Date last updated
21/04/2024
Date data sharing statement initially provided
11/10/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Exploring the Utility of Non-Invasive Coronary Angiography in Suspected Acute Coronary Syndromes with Low Level Troponin Elevation. (EN-ACT): A national study
Scientific title
Exploring the Utility of Non-Invasive Coronary Angiography in Suspected Acute Coronary Syndromes with Low Level Troponin Elevation : A national study
Secondary ID [1] 308100 0
Nil Known
Universal Trial Number (UTN)
U1111-1283-5108
Trial acronym
EN-ACT
Linked study record
Please note study ACTRN12621001292864 was a pilot study. This study is a continuation the pilot study - extended to be a national study. Two differences from the pilot study in the protocol is the study size (3000) and 4 additional study sites (Royal Adelaide Hospital, Royal Darwin Hospital, Alice Springs Hospital, Monash Medical Centre).

The HREC Committee accepted the Ethics Approval from the Pilot study and only requested amendment.

Health condition
Health condition(s) or problem(s) studied:
Acute Coronary Syndromes 327793 0
Condition category
Condition code
Cardiovascular 324864 324864 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.

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.

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.
Intervention code [1] 324547 0
Diagnosis / Prognosis
Comparator / control treatment
The control arm of the study Invasive coronary angiography (ICA) for this the low-intermediate risk cohort based on high sensitivity troponin sampling. Coronary findings will inform the treating clinician about subsequent management. Revascularisation recommendations will not be provided to clinical teams; subsequent clinical management, such as whether to proceed to Percutaneous coronary intervention (PCI) or whether Coronary artery bypass graft (CABG) is required will remain at clinician discretion as per routine practice.

ICA procedure takes approximately 30-60 minutes in total however could be longer depending on findings.

ICA is a common procedure often performed by specially trained heart doctors (cardiologists) in laboratories that look similar to operating theatres called ‘cath labs’. The procedure involves the cardiologist injecting a local anaesthetic either in the wrist, arm or groin to be able to then insert a thin, flexible tube called a catheter into the main artery at that point. The catheter is then guided through the main artery to the coronary arteries of the heart by the cardiologist who uses x-rays to visualise the progress of the catheter. When the catheter is in place, a small amount of contrast dye will be injected through the catheter into the coronary arteries so x-ray images can be taken.. The images produced show the cardiologist the details of the coronary arteries such as if there are any areas of abnormal narrowing (stenosis).
Control group
Active

Outcomes
Primary outcome [1] 332680 0
-Cardiovascular mortality Data will be acquired by through the SA Health data infrastructure for all SA residents. This data will be obtained by data linkage of public hospital admissions and care through systems such as EDDC, CRR, HIP, CLIP, ISSAC and EPAS/Sunrise (or other electronic medical records systems). Births, Deaths and Marriages and the National Death Index will be used to collect mortality and cause of death data for all participants.
Timepoint [1] 332680 0
Measured as the time from hospital admission to the first event.
Primary outcome [2] 332681 0
-New/recurrent Myocardial Infarction (MI) consistent with the current 4th Universal Definition of MI. Data will be acquired by through the SA Health data infrastructure for all SA residents. This data will be obtained by data linkage of public hospital admissions and care through systems such as EDDC, CRR, HIP, CLIP, ISSAC and EPAS/Sunrise (or other electronic medical records systems). Births, Deaths and Marriages and the National Death Index will be used to collect mortality and cause of death data for all participant
Timepoint [2] 332681 0
Measured as the time from hospital admission to the first event.
Primary outcome [3] 332682 0
-Unplanned coronary revascularisation Data will be acquired by through the SA Health data infrastructure for all SA residents. This data will be obtained by data linkage of public hospital admissions and care through systems such as EDDC, CRR, HIP, CLIP, ISSAC and EPAS/Sunrise (or other electronic medical records systems). Births, Deaths and Marriages and the National Death Index will be used to collect mortality and cause of death data for all participants.
Timepoint [3] 332682 0
Measured as the time from hospital admission to the first event.
Secondary outcome [1] 414347 0
- All cause death All data for in-hospital care will be obtained by data linkage of public hospital admissions and care through electronic medical records systems and linkage to national databases (e.g. NDI, MBS/PBS). Where required, paper medical records will be sought.
Timepoint [1] 414347 0
30 days, and 12 months post index presentation.
Secondary outcome [2] 414348 0
-Acute myocardial injury (MI) consistent with the latest Universal Definition of MI. All data for in-hospital care will be obtained by data linkage of public hospital admissions and care through electronic medical records systems and linkage to national databases (e.g. NDI, MBS/PBS). Where required, paper medical records will be sought.
Timepoint [2] 414348 0
30 days, and 12 months post index presentation.
Secondary outcome [3] 414349 0
- Proportion of patients receiving ICA during index hospitalisation. All data for in-hospital care will be obtained by data linkage of public hospital admissions and care through electronic medical records systems and linkage to national databases (e.g. NDI, MBS/PBS). Where required, paper medical records will be sought.
Timepoint [3] 414349 0
30 days, and 12 months post index presentation.
Secondary outcome [4] 414350 0
- Proportion of patients receiving coronary revascularisation during index hospitalisation All data for in-hospital care will be obtained by data linkage of public hospital admissions and care through electronic medical records systems and linkage to national databases (e.g. NDI, MBS/PBS). Where required, paper medical records will be sought.
Timepoint [4] 414350 0
30 days, and 12 months post index presentation.
Secondary outcome [5] 414351 0
- Proportion of patients prescribed ACS therapies at discharge All data for in-hospital care will be obtained by data linkage of public hospital admissions and care through electronic medical records systems and linkage to national databases (e.g. NDI, MBS/PBS). Where required, paper medical records will be sought.
Timepoint [5] 414351 0
30 days, and 12 months post index presentation.
Secondary outcome [6] 414352 0
- Representation with suspected ACS within 12-months All data for in-hospital care will be obtained by data linkage of public hospital admissions and care through electronic medical records systems and linkage to national databases (e.g. NDI, MBS/PBS). Where required, paper medical records will be sought.
Timepoint [6] 414352 0
30 days, and 12 months post index presentation.
Secondary outcome [7] 414353 0
Health-related quality of life (EQ-5D). This data will be obtained through telephone or mail-out follow up.
Timepoint [7] 414353 0
30 days, 6 months and 12 months post index presentation.
Secondary outcome [8] 414354 0
- Health service resource utilisation, total length of stay, coronary care length of stay, time to investigations (this is one combined outcome) All data for in-hospital care will be obtained by data linkage of public hospital admissions and care through electronic medical records systems and linkage to national databases (e.g. NDI, MBS/PBS). Where required, paper medical records will be sought.
Timepoint [8] 414354 0
Continually assessed throughout the recruitment period. Measured by economic analysis: 1) a within-trial cost effectiveness analysis (i.e. comparing the observed costs and quality adjusted life years (QALYs) of the intervention and control groups during the trial period), 2) an analysis of the long-term cost effectiveness of CTCA, adapting an existing decision analytic model.
Secondary outcome [9] 414355 0
-Chronic myocardial injury (MI) consistent with the latest Universal Definition of MI. All data for in-hospital care will be obtained by data linkage of public hospital admissions and care through electronic medical records systems and linkage to national databases (e.g. NDI, MBS/PBS). Where required, paper medical records will be sought.
Timepoint [9] 414355 0
30 days, 6 months and 12 months post index presentation.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

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 is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The primary analysis population will include all participants who received their randomly allocated coronary investigation as the first coronary imaging test (i.e. per protocol population), with secondary sensitivity analyses undertaken using the intention-to-treat population (as randomized). The results of the trial will be reported according to CONSORT guidelines.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
31/10/2022
Actual
15/12/2023
Date of last participant enrolment
Anticipated
31/12/2025
Actual
Date of last data collection
Anticipated
31/12/2026
Actual
Sample size
Target
3000
Accrual to date
17
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 23288 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [2] 23289 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [3] 23290 0
Royal Darwin Hospital - Tiwi
Recruitment hospital [4] 23291 0
Alice Springs Hospital - Alice Springs
Recruitment hospital [5] 23295 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment postcode(s) [1] 38661 0
5042 - Bedford Park
Recruitment postcode(s) [2] 38662 0
5000 - Adelaide
Recruitment postcode(s) [3] 38663 0
0810 - Tiwi
Recruitment postcode(s) [4] 38664 0
0870 - Alice Springs
Recruitment postcode(s) [5] 38668 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 312354 0
Government body
Name [1] 312354 0
National Health and Medical Research Council (NHMRC)
Country [1] 312354 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
Sturt Road, Bedford Park SA 5042
Country
Australia
Secondary sponsor category [1] 313920 0
None
Name [1] 313920 0
N/A
Address [1] 313920 0
Country [1] 313920 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311717 0
Southern Adelaide Clinical Human Research Ethics Committee.
Ethics committee address [1] 311717 0
Ethics committee country [1] 311717 0
Australia
Date submitted for ethics approval [1] 311717 0
05/10/2022
Approval date [1] 311717 0
06/10/2022
Ethics approval number [1] 311717 0

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

Contacts
Principal investigator
Name 122114 0
A/Prof Sam Lehman
Address 122114 0
Flinders Medical Centre GPO Box 2100, Adelaide 5001, South Australia
Country 122114 0
Australia
Phone 122114 0
+61 433 967 009
Fax 122114 0
Email 122114 0
[email protected]
Contact person for public queries
Name 122115 0
Kristina Lambrakis
Address 122115 0
Flinders University
Sturt Road
BEDFORD PARK SA 5042
Country 122115 0
Australia
Phone 122115 0
+613751111854
Fax 122115 0
Email 122115 0
[email protected]
Contact person for scientific queries
Name 122116 0
Kristina Lambrakis
Address 122116 0
Flinders University
Sturt Road
BEDFORD PARK SA 5042
Country 122116 0
Australia
Phone 122116 0
+613751111854
Fax 122116 0
Email 122116 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.