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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Type of registration
Prospectively registered

Titles & IDs
Public title
A study to determine if IL-4 is useful as a marker of inflammation of atherosclerosis
Scientific title
A study to determine if IL-4 is useful as a marker of inflammation of atherosclerosis
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atherosclerosis in ischaemic heart disease. 783 0
Condition category
Condition code
Cardiovascular 857 857 0 0
Other cardiovascular diseases

Study type
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This pilot study involves the testing of a new assay to detect IL-4. A once only sample of two mls of blood will be taken from 4 specific groups of patients to test for the presence of IL-4. The cytokine, IL-4, measured by this new assay, is abnormally elevated in the blood of patients with coronary artery disease, the degree of abnormality of blood IL-4 is related to important clinical events in such patients, including severity of disease, acute complications and treatment.
Intervention code [1] 449 0
Early detection / Screening
Comparator / control treatment
Control group

Primary outcome [1] 1100 0
To measure IL-4 by a new rapid point-of-care technique in patients with documented coronary artery disease presenting in a variety of acute clinical circumstances
Timepoint [1] 1100 0
Secondary outcome [1] 2036 0
To evaluate any abnormal measurements in relation to the severity of the disease, acute vascular complications and newly prescribed medication.
Timepoint [1] 2036 0

Key inclusion criteria
All patients presenting in the settings described will be eligible to participate. There will be no criteria for exclusion, apart from unwillingness to participate. It is proposed initially to study four small groups of patients with ischaemic heart disease. 1. Patients with unstable coronary artery disease admitted for Coronary Care will be studied on admission and then daily until coronary angiography is performed (or decided against). The IL-4 results will be related to the patient's clinical course, ECG changes, cardiac enzyme levels and angiographic findings. 2. Patients having coronary angioplasty, who have not been studied as part of group 1, will be studied before, immediately after and 24 hours after the procedure. The IL-4 results will be used to assess whether it can relate to the iatrogenic plaque rupture which this procedure involves. 3. Patients having coronary artery bypass grafting will be studied before, immediately after and 24 hours after surgery. On pump and off pump procedures (half in each subgroup) will be separately studied. The IL-4 results will be related to the extent (number of grafts) and duration of the surgical procedure. 4. Patients with stable coronary artery disease about to receive statin and/or angiotensin-converting enzyme inhibitor therapy will be studied before and twice weekly after the commencement of therapy for four weeks. The IL-4 results will be related to the dose and duration of drug therapy.
Minimum age
No limit
Maximum age
No limit
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
Unwillingness to participate.

Study design
Defined population
Statistical methods / analysis

Recruitment status
Not yet recruiting
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 943 0
Name [1] 943 0
Intensive Care Departmental Funding, Royal Melbourne Hospital
Address [1] 943 0
Country [1] 943 0
Primary sponsor type
Intensive Care Unit, RMH
Secondary sponsor category [1] 803 0
Name [1] 803 0
Address [1] 803 0
Country [1] 803 0

Ethics approval
Ethics application status
Ethics committee name [1] 2241 0
Royal Melbourne Hospital
Ethics committee address [1] 2241 0
Ethics committee country [1] 2241 0
Date submitted for ethics approval [1] 2241 0
Approval date [1] 2241 0
Ethics approval number [1] 2241 0

Brief summary
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 36103 0
Address 36103 0
Country 36103 0
Phone 36103 0
Fax 36103 0
Email 36103 0
Contact person for public queries
Name 9638 0
Dr Julian Hunt-Smith
Address 9638 0
Intensive Care Unit
Royal Melbourne Hospital
Grattan Street
Parkville VIC 3050
Country 9638 0
Phone 9638 0
+61 3 93427441
Fax 9638 0
+61 3 93428812
Email 9638 0
Contact person for scientific queries
Name 566 0
Dr Julian Hunt-Smith
Address 566 0
Intensive Care Unit
Royal Melbourne Hospital
Grattan Street
Parkville VIC 3050
Country 566 0
Phone 566 0
+61 3 93427710
Fax 566 0
+61 3 93428812
Email 566 0

No information has been provided regarding IPD availability
Summary results
No Results