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

Primary Purpose

Atherosclerosis, Ischemic Heart Disease

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Measuring IL-4 levels
Sponsored by
Melbourne Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Atherosclerosis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Other

    Other

    Other

    Other

    Arm Label

    Unstable coronary artery disease

    Coronary Angioplasty Patients

    Coronary bypass grafts patients

    Stable coronary Artery Diseaese Patients

    Arm Description

    Patients with unstable coronary artery disease will have daily IL6 levels

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

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

    Once the patients are commenced on treatment with statins and or angiotensin converting enzyme they will have twice weekly levels taken

    Outcomes

    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

    Secondary Outcome Measures

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

    Full Information

    First Posted
    November 17, 2005
    Last Updated
    April 23, 2015
    Sponsor
    Melbourne Health
    Collaborators
    The Intensive Care Unit Departmental Funding
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00256035
    Brief Title
    Interleukin-4 (IL-4) as a Marker of Atherosclerosis
    Official Title
    IL-4 as a Marker of Atherosclerosis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2015
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Melbourne Health
    Collaborators
    The Intensive Care Unit Departmental Funding

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.
    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: 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 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. 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. Patients having coronary angioplasty. They will be studied before, immediately after and 24 hours after the procedure. Patients having coronary artery bypass grafting will be studied immediately after and 24 hours post surgery. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Atherosclerosis, Ischemic Heart Disease

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Unstable coronary artery disease
    Arm Type
    Other
    Arm Description
    Patients with unstable coronary artery disease will have daily IL6 levels
    Arm Title
    Coronary Angioplasty Patients
    Arm Type
    Other
    Arm Description
    Patients having coronary angioplasty will have levels taken before and immediately after the proceedure and 24 hours post.
    Arm Title
    Coronary bypass grafts patients
    Arm Type
    Other
    Arm Description
    Patients will have levels collected immediately after and 24 hours post procedure
    Arm Title
    Stable coronary Artery Diseaese Patients
    Arm Type
    Other
    Arm Description
    Once the patients are commenced on treatment with statins and or angiotensin converting enzyme they will have twice weekly levels taken
    Intervention Type
    Procedure
    Intervention Name(s)
    Measuring IL-4 levels
    Primary Outcome Measure Information:
    Title
    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 Measure Information:
    Title
    To evaluate any abnormal measurements in relation to the severity of the disease, acute vascular complications, and newly prescribed medications
    Time Frame
    Hospital Discharge

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Megan Robertson
    Organizational Affiliation
    Melbourne Health
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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