The RADICAL project: impact of three different diagnostic tests for patients presenting with chest pain.

• Register: ANZCTR
• Last refreshed on: 22 February 2021
• Main ID: ACTRN12616000147482
• Date of registration: 08/02/2016
• Prospective Registration: Yes
• Primary sponsor: Royal Perth Hospital
• 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
• Date of first enrolment: 04/05/2016
• Target sample size: 500
• Recruitment status: Recruiting
• URL: https://anzctr.org.au/ACTRN12616000147482.aspx
• Study type: Interventional
• Study design: Purpose: Diagnosis; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Efficacy;
• Phase: Not Applicable

Countries of recruitment

Australia

Contacts

• Name: Ms Sonia Kalathil

• Name: Dr Jonathan Spiro

Key inclusion & exclusion criteria

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.
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.

Age minimum: 18 Years
Age maximum: 85 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Coronary artery disease;Angina pectoris;
Coronary artery disease
Angina pectoris

Cardiovascular - Coronary heart disease

Intervention(s)

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.

Primary Outcome(s)

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. [2 years ]

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.[4 weeks from initial clinic assessment.]

Secondary Outcome(s)

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.[Study duration (2 years)]

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. [2 years ]

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.[2 years ]

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.[2 years]

Secondary ID(s)

None

Source(s) of Monetary Support

Department of Health, Western Australia

Ethics review

Status: Approved
Approval date: 04/05/2016
Contact:

Department of Health Human Research Ethics Committee

Status: Approved
Approval date: 04/05/2016
Contact:

Royal Perth Hospital Human Research Ethics Committee (EC00270)

Status: Not approved
Approval date:
Contact:

Western Australian Aboriginal Health Ethics Committee