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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
  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: 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 ]

Estimated Enrollment: 80
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

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00256035

Contacts
Contact: Julian Hunt-Smith +61 3 93427441 julian.hunt-smith@mh.org.au

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

No publications provided

ClinicalTrials.gov Identifier: NCT00256035     History of Changes
Other Study ID Numbers: 2002.156
Study First Received: November 17, 2005
Last Updated: February 3, 2009
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

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

ClinicalTrials.gov processed this record on November 19, 2014