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

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00256035
First Posted: November 21, 2005
Last Update Posted: April 27, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
The Intensive Care Unit Departmental Funding
Information provided by:
Melbourne Health
  Purpose

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.


Condition Intervention
Atherosclerosis Ischemic Heart Disease Procedure: Measuring IL-4 levels

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: IL-4 as a Marker of Atherosclerosis

Resource links provided by NLM:


Further study details as provided by Melbourne Health:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • To evaluate any abnormal measurements in relation to the severity of the disease, acute vascular complications, and newly prescribed medications [ Time Frame: Hospital Discharge ]

Enrollment: 0
Arms Assigned Interventions
Unstable coronary artery disease
Patients with unstable coronary artery disease will have daily IL6 levels
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.
Procedure: Measuring IL-4 levels
Coronary bypass grafts patients
Patients will have levels collected immediately after and 24 hours post procedure
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
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00256035


Sponsors and Collaborators
Melbourne Health
The Intensive Care Unit Departmental Funding
Investigators
Principal Investigator: Megan Robertson Melbourne Health
  More Information

ClinicalTrials.gov Identifier: NCT00256035     History of Changes
Other Study ID Numbers: 2002.156
First Submitted: November 17, 2005
First Posted: November 21, 2005
Last Update Posted: April 27, 2015
Last Verified: April 2015

Additional relevant MeSH terms:
Heart Diseases
Atherosclerosis
Myocardial Ischemia
Coronary Artery Disease
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Coronary Disease