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

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
The Intensive Care Unit Departmental Funding
Information provided by:
Melbourne Health
ClinicalTrials.gov Identifier:
NCT00256035
First received: November 17, 2005
Last updated: April 23, 2015
Last verified: April 2015

November 17, 2005
April 23, 2015
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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.
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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
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Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Atherosclerosis
  • Ischemic Heart Disease
Procedure: Measuring IL-4 levels
  • Unstable coronary artery disease
    Patients with unstable coronary artery disease will have daily IL6 levels
    Intervention: Procedure: Measuring IL-4 levels
  • Coronary Angioplasty Patients
    Patients having coronary angioplasty will have levels taken before and immediately after the proceedure and 24 hours post.
    Intervention: Procedure: Measuring IL-4 levels
  • Coronary bypass grafts patients
    Patients will have levels collected immediately after and 24 hours post procedure
    Intervention: Procedure: Measuring IL-4 levels
  • 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
    Intervention: 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.
 
Withdrawn
0
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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
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00256035
2002.156
No
Not Provided
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Melbourne Health
The Intensive Care Unit Departmental Funding
Principal Investigator: Megan Robertson Melbourne Health
Melbourne Health
April 2015

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