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

IL-4 as a Marker of Atherosclerosis

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.

Study Overview

• Status: Withdrawn
• Conditions: Atherosclerosis; Ischemic Heart Disease
• Intervention / Treatment: Procedure: Measuring IL-4 levels

Detailed 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.

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Unstable coronary artery disease; Patients with unstable coronary artery disease will have daily IL6 levels	Procedure: Measuring IL-4 levels
Other: Coronary Angioplasty Patients; Patients having coronary angioplasty will have levels taken before and immediately after the proceedure and 24 hours post.	Procedure: Measuring IL-4 levels
Other: Coronary bypass grafts patients; Patients will have levels collected immediately after and 24 hours post procedure	Procedure: Measuring IL-4 levels
Other: Stable coronary Artery Diseaese Patients; Once the patients are commenced on treatment with statins and or angiotensin converting enzyme they will have twice weekly levels taken	Procedure: Measuring IL-4 levels

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
To evaluate any abnormal measurements in relation to the severity of the disease, acute vascular complications, and newly prescribed medications	Hospital Discharge

Collaborators and Investigators

• Sponsor: Melbourne Health
• Collaborators: The Intensive Care Unit Departmental Funding
• Investigators: Principal Investigator: Megan Robertson, Melbourne Health

Study record dates

Study Registration Dates

• First Submitted: November 17, 2005
• First Submitted That Met QC Criteria: November 17, 2005
• First Posted (Estimate): November 21, 2005

Study Record Updates

• Last Update Posted (Estimate): April 27, 2015
• Last Update Submitted That Met QC Criteria: April 23, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Atherosclerosis
• Other Study ID Numbers: 2002.156