Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001292864
Ethics application status
Approved
Date submitted
2/08/2021
Date registered
24/09/2021
Date last updated
25/04/2024
Date data sharing statement initially provided
24/09/2021
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 pilot study
Scientific title
Exploring the Utility of Non-Invasive Coronary Angiography in Suspected Acute Coronary Syndromes with Low Level Troponin Elevation : A pilot study
Secondary ID [1] 304880 0
Nil Known
Universal Trial Number (UTN)
U1111-1268-3131
Trial acronym
EN-ACT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Coronary Syndromes 323006 0
Condition category
Condition code
Cardiovascular 320571 320571 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.

a) 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.

b) 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] 321277 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.

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

b) 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] 328393 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] 328393 0
Measured as the time from hospital admission to the first event.
Primary outcome [2] 328471 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 participants.
Timepoint [2] 328471 0
Measured as the time from hospital admission to the first event.
Primary outcome [3] 328474 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] 328474 0
Measured as the time from hospital admission to the first event.
Secondary outcome [1] 398882 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] 398882 0
30 days, and 12 months post index presentation.
Secondary outcome [2] 398885 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] 398885 0
30 days, and 12 months post index presentation.
Secondary outcome [3] 398887 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] 398887 0
30 days, and 12 months post index presentation
Secondary outcome [4] 398891 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] 398891 0
30 days, and 12 months post index presentation
Secondary outcome [5] 398892 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] 398892 0
30 days, and 12 months post index presentation.
Secondary outcome [6] 398895 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] 398895 0
30 days, and 12 months post index presentation.
Secondary outcome [7] 398897 0
Health-related quality of life (EQ-5D).

This data will be obtained through telephone or mail-out follow up.
Timepoint [7] 398897 0
30 days, 6 months and 12 months post index presentation.
Secondary outcome [8] 398899 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] 398899 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] 399120 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] 399120 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 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
Stopped early
Data analysis
No data analysis planned
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Funding received for large scale outcomes-driven trial, registered separately as EN-ACT National
Date of first participant enrolment
Anticipated
1/10/2021
Actual
29/09/2022
Date of last participant enrolment
Anticipated
Actual
28/07/2023
Date of last data collection
Anticipated
Actual
28/07/2023
Sample size
Target
26
Accrual to date
Final
8
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 20084 0
Flinders Medical Centre - Bedford Park
Recruitment postcode(s) [1] 34792 0
5042 - Bedford Park

Funding & Sponsors
Funding source category [1] 309254 0
Charities/Societies/Foundations
Name [1] 309254 0
Flinders Foundation Health Seed Grants
Country [1] 309254 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
Sturt Road, Bedford Park SA 5042
Country
Australia
Secondary sponsor category [1] 310475 0
None
Name [1] 310475 0
n/a
Address [1] 310475 0
Country [1] 310475 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309099 0
Southern Adelaide Clinical Human Research Ethics Committee.
Ethics committee address [1] 309099 0
1 Flinders Drive, Bedford Park SA 5042
Ethics committee country [1] 309099 0
Australia
Date submitted for ethics approval [1] 309099 0
26/07/2021
Approval date [1] 309099 0
21/09/2021
Ethics approval number [1] 309099 0

Summary
Brief summary
High sensitivity troponin assays have led to increased numbers of patients presented to the emergency department (ED) for suspected acute coronary syndrome (ACS) now having detectable troponin levels. For those with low level troponin elevated, there is limited evidence to guide care. It is suggested that individuals in this zone, have a higher risk of poor outcomes and the risk versus benefit of invasive coronary angiography (ICA) is less clear as the likelihood of an evolving heart attack is lower. Computed tomography coronary angiography (CTCA), being a less invasive alternate approach, may provide useful information to inform subsequent care to these lower risk patients. This randomised clinical trial aims to investigate CTCA vs. ICA in suspected ACS with low level troponin elevations in the ED. Outcomes will be assessed at 30 days and 12 months. A pilot study will be performed initially until greater funding can be sourced.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 112970 0
Dr Sam Lehman
Address 112970 0
Flinders Medical Centre
GPO Box 2100, Adelaide 5001, South Australia
Country 112970 0
Australia
Phone 112970 0
+61 433 967 009
Fax 112970 0
Email 112970 0
[email protected]
Contact person for public queries
Name 112971 0
Ms Kristina Lambrakis
Address 112971 0
Flinders University
Sturt Road
Bedford Park SA 5042
Country 112971 0
Australia
Phone 112971 0
+613751111854
Fax 112971 0
Email 112971 0
[email protected]
Contact person for scientific queries
Name 112972 0
Ms Kristina Lambrakis
Address 112972 0
Flinders University
Sturt Road
Bedford Park SA 5042
Country 112972 0
Australia
Phone 112972 0
+613751111854
Fax 112972 0
Email 112972 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
This study is unlikely to share individual data because the pilot has a very limited number of participants from a single site over a specific period of time, therefore if IPD were shared it would potentially unintentionally make the data identifiable (i.e. individual participants will be able to be identified).


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.