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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Melbourne Health.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
The Intensive Care Unit Departmental Funding
Information provided by:
Melbourne Health
ClinicalTrials.gov Identifier:
NCT00256035
First received: November 17, 2005
Last updated: February 3, 2009
Last verified: February 2009

November 17, 2005
February 3, 2009
Not Provided
Not Provided
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 [ Time Frame: Hospital Discharge ]
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
Complete list of historical versions of study NCT00256035 on ClinicalTrials.gov Archive Site
To evaluate any abnormal measurements in relation to the severity of the disease, acute vascular complications, and newly prescribed medications [ Time Frame: Hospital Discharge ]
To evaluate any abnormal measurements in relation to the severity of the disease, acute vascular complications and newly prescribed medications.
Not Provided
Not Provided
 
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.

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.
Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Atherosclerosis
  • Ischemic Heart Disease
Procedure: Measuring IL-4 levels
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
80
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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.
Both
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No
Contact: Julian Hunt-Smith +61 3 93427441 julian.hunt-smith@mh.org.au
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NCT00256035
2002.156
No
Not Provided
Melbourne Health
The Intensive Care Unit Departmental Funding
Principal Investigator: Megan Robertson Melbourne Health
Melbourne Health
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP