Interleukin-4 (IL-4) as a Marker of Atherosclerosis

Atherosclerosis Clinical Trial

Official title:

IL-4 as a Marker of Atherosclerosis

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00256035
• Other study ID #: 2002.156
• Status: Withdrawn
• Phase: N/A
• First received: November 17, 2005
• Last updated: April 23, 2015

Study information

• Verified date: April 2015
• Source: Melbourne Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial Summary

In recent years, medical research into the cause and progression of heart disease due to narrowing and blockage of blood vessels to the heart muscle has improved the understanding of ischemic heart disease. It is now accepted that both the development and later progression with sudden blockage of blood vessels are associated with inflammation, although it remains unknown exactly what triggers this inflammatory process. It is possible that new blood tests which measure markers of inflammation in the bloodstream may be useful to help identify patients at risk of heart damage and assess response to treatment.

The study plans to assess a new blood test for a known marker of inflammation (IL-4) in patients with heart disease.

The hypothesis of this study is that, the cytokine, IL-4, measured by a new assay, is abnormally elevated in the blood of patients with coronary artery disease.

Also hypothesized is that 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.

Description:

This is a single centre, prospective, non randomised, non controlled, pilot study of the potential abnormality of a new test group of patients in whom the results are postulated to be abnormal.

The specific aims of the study are:

1. To measure IL-4 by a new rapid on-site technique in patients with documented coronary artery disease presenting in a variety of acute clinical circumstances

2. To evaluate any abnormal measurements in relation to the severity of the disease, acute vascular complication and newly prescribed medications.

It is proposed to study 4 small groups of patients with ischemic heart disease.

1. Patients with unstable coronary artery disease admitted to the Coronary Care Unit. They will be studied on admission and then daily until coronary angiography is performed.

2. Patients having coronary angioplasty. They will be studied before, immediately after and 24 hours after the procedure.

3. Patients having coronary artery bypass grafting will be studied immediately after and 24 hours post surgery.

4. Patients with stable coronary artery disease about to receive a statin and or angiotensin-converting enzyme inhibitor therapy will be studied before and twice weekly after commencement of therapy for 4 weeks.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• All patients (either sex and any age) presenting in the settings described will be eligible to participate.

Exclusion Criteria:

• An unwillingness to participate.

Study Design

Allocation: Non-Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Atherosclerosis
• Coronary Artery Disease
• Ischemic Heart Disease
• Myocardial Ischemia

Intervention

Procedure:
• Measuring IL-4 levels

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Melbourne Health	The Intensive Care Unit Departmental Funding

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To measure the 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		Hospital Discharge
Secondary	To evaluate any abnormal measurements in relation to the severity of the disease, acute vascular complications, and newly prescribed medications		Hospital Discharge