Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000147482
Ethics application status
Approved
Date submitted
26/01/2016
Date registered
8/02/2016
Date last updated
12/02/2021
Date data sharing statement initially provided
12/02/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The RADICAL project: impact of three different diagnostic tests for patients presenting with chest pain.
Scientific title
Impact of Rapid Access to cardiology Determined multi-modality testing among Individuals presenting with new onset Chest pain: improving quality, efficiency and cost effectiveness at Royal Perth HospitAL: The RADICAL project
Secondary ID [1] 288102 0
None
Universal Trial Number (UTN)
Trial acronym
RADICAL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary artery disease 296965 0
Angina pectoris 296966 0
Condition category
Condition code
Cardiovascular 297223 297223 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients attending the rapid access chest pain clinic shall be invited to participate. Individuals assessed as being at intermediate risk of significant coronary artery disease shall be randomised to one of three routinely used investigations; exercise treadmill test (ETT), CT coronary angiogram (CTCA) or a myocardial perfusion scan (MPS).

Exercise treadmill test, involves monitoring your heart whilst you walk quickly on a treadmill, similar to those found in a gym. The test is performed by experienced exercise physiologists, within the cardiology department at Royal Perth Hoispital, and usually takes about 10-12 minutes.

CT coronary angiogram; involves an injection of dye into a blood vessel in your arm, whilst an X-ray scan of your heart is performed. Occassionally a single small dose of a medicine (beta blocker) may be given to you in order to slow your heart down to optimise the images. The CT scan takes just a few minutes and is performed by radiologists.

Myocardial perfusion scan; involves an assessment of the blood flow to your heart muscle under conditions of rest and stress (either exercise on a treadmill, or following the injection of a medicine to relax your blood vessels and speed up the flow of blood in your heart (coronary) arteries). This scan involves the injection of a small amount of radioactive tracer. The two scans take about an hour each and are performed on two consecutive days. The scans are performed by radiologists within the Nuclear Medicine department at Royal Perth Hospital.
Intervention code [1] 293411 0
Diagnosis / Prognosis
Comparator / control treatment
The comparator for this study will be the exercise treadmill test, as this has historically been considered the favoured test.
Control group
Active

Outcomes
Primary outcome [1] 297158 0
Among patients at intermediate risk of signifciant coronary artery disease, which investigation improves diagnostic certainty (for angina) at 4 weeks?

'Diagnostic certainty' shall be determined by the physician who reviews the patient in the clinic. The physician shall be asked 'are you certain that the patient's symptoms (angina) are due to coronary artery disease?'; yes, probable, unlikely, or no.

This shall then be repeated at 4 weeks, following reciept of the results of the test performed. We shall then analyse which test, if any, provided the greatest change in diagnostic certainty between these two time points.
Timepoint [1] 297158 0
4 weeks from initial clinic assessment.
Primary outcome [2] 297159 0
Among patients at intermediate risk of significant coronary artery disease, which investigation is most cost-effective?

This analysis shall be performed by assessing which test most frequently provided the highest diagnostic confidence, therefore removing the need for costly repeated testing.
Timepoint [2] 297159 0
2 years
Secondary outcome [1] 320197 0
Compared to current standard practice, does a RACPC improve time from referral to assessment, treatment, diagnosis and revascularisation?

This will be assessed by analysing records of time points (date of referral, date of clinic, date of test, date when medication commenced, date diagnosis made and date of revascularisation if relevant). These time intervals shall then be compared to current (pre-chest pain clinic) standard of care.
Timepoint [1] 320197 0
Study duration (2 years)
Secondary outcome [2] 320198 0
Compared to current standard practice, does a RACPC reduce cumulative radiation dose per patient?

This will be calculated by analysing the number and types of tests performed on each patient before and after the introduction of the new rapid access chest pain clinic.
Timepoint [2] 320198 0
2 years
Secondary outcome [3] 320199 0
Compared to current standard practice, does a RACPC reduce the total number of investigations per patient?

This will be calculated by summing the number of tests performed, in order to achieve a confident diagnosis / management plan, before and after the introduction of the rapid access chest pain clinic.
Timepoint [3] 320199 0
2 years
Secondary outcome [4] 320200 0
Compared to current standard practice, does a RACPC deliver cost savings?

This analysis will be performed in collaboration with the health economics team at the University of Western Australia, and will aim to assess the cost of managing patients before and after the introduction of the rapid access chest pain clinic.

Specifically, we aim to compare the cost of tests performed, costs involved in reviewing patients in the new clinic compared to the original cardiology outpatient clinic, and cost savings that were generated by facilitating earlier discharge of patients from ED and inpatient medical wards and prevention of unplanned hospital presentation and admissions.
Timepoint [4] 320200 0
2 years

Eligibility
Key inclusion criteria
Inclusion criteria: age 18–85 years with new onset (<3 months) chest pain, suggestive of stable angina pectoris. Our target population includes patients who live within the RPH postcode-allocated referral areas and patients whom live rurally / remotely who would normally be referred to RPH.
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria: Patients with acute coronary syndrome (ACS) are excluded from this service and should be referred via conventional pathways, such as referral to ED. Other exclusions include: known coronary artery disease, significant cognitive impairment, multiple co-morbidities (involving current input from other clinical specialists), significant valvular heart disease or suspected arrhythmia and advanced renal failure (eGFR <30ml/min). These patients will continue to be assessed in the general cardiology outpatient clinics.

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)
The computer generates the randomised sequence, which shall allocate patients to one of three tests, in a 1:1:1 fashion.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
If randomised to an exercise treadmill test, but is then found to be physically unable to perform the treadmill test (having said, or being assessed as able to perform the test prior to randomisation) these patients shall be re-randomised to one of the other investigations; CT scan or myocardial perfusion scan.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Statistical Analysis: Demographic characteristics between the three arms will be compared using the chi-squared test (for categorical variables) or t-test (for continuous variables). Cox regression will be used to compare presentations for chest pain and major adverse cardiac events between the three intervention groups, adjusting for relevant covariates (e.g. age, sex, comorbidity, baseline risk factors, baseline PTL, ECG findings). Change in angina score (30 days) and hazard ratios from the Cox models (6 and 12 months) will be used in calculating the cost-effectiveness ratios for the diagnostic tests. Statistical tests will be two-sided at the 5% level of significance.

Power Calculation: A sample size of 300 patients, 110 randomised to CTCA and 190 randomised to functional testing (ETT or MPS) would have 80% power (with a 2-sided a of 0.05) to detect a difference of 15% in the confident diagnosis of the presence or absence of angina (i.e. percentage of patients categorised as ‘yes’ or ‘no’ as opposed to ‘unlikely’ or ‘probable’) at 4 weeks, which is comparable to previous data.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
16/02/2016
Actual
4/05/2016
Date of last participant enrolment
Anticipated
1/07/2022
Actual
Date of last data collection
Anticipated
1/07/2023
Actual
Sample size
Target
500
Accrual to date
389
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 5124 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 12589 0
6000 - Perth

Funding & Sponsors
Funding source category [1] 292765 0
Government body
Name [1] 292765 0
Department of Health, Western Australia
Country [1] 292765 0
Australia
Primary sponsor type
Hospital
Name
Royal Perth Hospital
Address
197 Wellington Street
Perth WA 6000
Australia
Country
Australia
Secondary sponsor category [1] 291499 0
None
Name [1] 291499 0
Address [1] 291499 0
Country [1] 291499 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294253 0
Royal Perth Hospital Human Research Ethics Committee (EC00270)
Ethics committee address [1] 294253 0
Ethics committee country [1] 294253 0
Australia
Date submitted for ethics approval [1] 294253 0
03/11/2015
Approval date [1] 294253 0
04/05/2016
Ethics approval number [1] 294253 0
RGS0000000643
Ethics committee name [2] 294254 0
Western Australian Aboriginal Health Ethics Committee
Ethics committee address [2] 294254 0
Ethics committee country [2] 294254 0
Australia
Date submitted for ethics approval [2] 294254 0
03/11/2015
Approval date [2] 294254 0
Ethics approval number [2] 294254 0
Pending
Ethics committee name [3] 294255 0
Department of Health Human Research Ethics Committee
Ethics committee address [3] 294255 0
Ethics committee country [3] 294255 0
Australia
Date submitted for ethics approval [3] 294255 0
03/11/2015
Approval date [3] 294255 0
04/05/2016
Ethics approval number [3] 294255 0
RGS0000000643

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

Contacts
Principal investigator
Name 62054 0
Dr Jonathan Spiro
Address 62054 0
Department of Cardiology
Royal Perth Hospital
197 Wellington Street
Perth, 6000
Western Australia
Country 62054 0
Australia
Phone 62054 0
+61 8 9224 3185
Fax 62054 0
+61 8 9224 3175
Email 62054 0
[email protected]
Contact person for public queries
Name 62055 0
Sonia Kalathil
Address 62055 0
Specialist Chest Pain Nurse
Department of Cardiology
Royal Perth Hospital
197 Wellington Street
Perth, 6000
Western Australia
Country 62055 0
Australia
Phone 62055 0
+61 89224 2719
Fax 62055 0
+61 8 9224 3175
Email 62055 0
[email protected]
Contact person for scientific queries
Name 62056 0
Jonathan Spiro
Address 62056 0
Department of Cardiology
Royal Perth Hospital
197 Wellington Street
Perth, 6000
Western Australia
Country 62056 0
Australia
Phone 62056 0
+61 8 9224 2719
Fax 62056 0
+61 8 9224 3175
Email 62056 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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
10665Ethical approval  [email protected]



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically
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