Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000650695
Ethics application status
Approved
Date submitted
10/09/2005
Date registered
17/10/2005
Date last updated
6/11/2012
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

Intervention/exposure
Study type
Observational
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

Outcomes
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

Eligibility
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
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unwillingness to participate.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 943 0
Hospital
Name [1] 943 0
Intensive Care Departmental Funding, Royal Melbourne Hospital
Country [1] 943 0
Australia
Primary sponsor type
Hospital
Name
Intensive Care Unit, RMH
Address
Country
Australia
Secondary sponsor category [1] 803 0
None
Name [1] 803 0
Nil
Address [1] 803 0
Country [1] 803 0

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

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

Contacts
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
Australia
Phone 9638 0
+61 3 93427441
Fax 9638 0
+61 3 93428812
Email 9638 0
julian.hunt-smith@mh.org.au
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
Australia
Phone 566 0
+61 3 93427710
Fax 566 0
+61 3 93428812
Email 566 0
julian.huntsmith@mh.org.au

No information has been provided regarding IPD availability


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.