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

NCT00256035 | Withdrawn

• 1 other identifier: 2002.156
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Atherosclerosis; Ischemic Heart Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• To evaluate any abnormal measurements in relation to the severity of the disease, acute vascular complications, and newly prescribed medications

  Hospital Discharge

Study Arms (4)

Unstable coronary artery disease

OTHER

Patients with unstable coronary artery disease will have daily IL6 levels

Procedure: Measuring IL-4 levels

Coronary Angioplasty Patients

OTHER

Patients having coronary angioplasty will have levels taken before and immediately after the proceedure and 24 hours post.

Procedure: Measuring IL-4 levels

Coronary bypass grafts patients

OTHER

Patients will have levels collected immediately after and 24 hours post procedure

Procedure: Measuring IL-4 levels

Stable coronary Artery Diseaese Patients

OTHER

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

Interventions

Measuring IL-4 levels PROCEDURE

Coronary Angioplasty Patients; Coronary bypass grafts patients; Stable coronary Artery Diseaese Patients; Unstable coronary artery disease

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• An unwillingness to participate.

Sponsors & Collaborators

• Melbourne Health: lead
• The Intensive Care Unit Departmental Funding: collaborator

MeSH Terms

Conditions

Atherosclerosis; Myocardial Ischemia

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Heart Diseases

Study Officials

• Megan Robertson

  Melbourne Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 17, 2005
• First Posted: November 21, 2005
• Last Updated: April 27, 2015

Record last verified: 2015-04