Interleukin-4 (IL-4) as a Marker of Atherosclerosis
Recruitment status was Not yet recruiting
|First Received Date ICMJE||November 17, 2005|
|Last Updated Date||February 3, 2009|
|Start Date ICMJE||Not Provided|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||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 ]|
|Original Primary Outcome Measures ICMJE
||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|
|Change History||Complete list of historical versions of study NCT00256035 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
||To evaluate any abnormal measurements in relation to the severity of the disease, acute vascular complications, and newly prescribed medications [ Time Frame: Hospital Discharge ]|
|Original Secondary Outcome Measures ICMJE
||To evaluate any abnormal measurements in relation to the severity of the disease, acute vascular complications and newly prescribed medications.|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Interleukin-4 (IL-4) as a Marker of Atherosclerosis|
|Official Title ICMJE||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:
It is proposed to study 4 small groups of patients with ischemic heart disease.
|Study Type ICMJE||Interventional|
|Study Phase||Not Provided|
|Study Design ICMJE||Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Intervention ICMJE||Procedure: Measuring IL-4 levels|
|Study Arm (s)||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Not yet recruiting|
|Estimated Enrollment ICMJE||80|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Accepts Healthy Volunteers||No|
|Location Countries ICMJE||Not Provided|
|NCT Number ICMJE||NCT00256035|
|Other Study ID Numbers ICMJE||2002.156|
|Has Data Monitoring Committee||No|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Melbourne Health|
|Collaborators ICMJE||The Intensive Care Unit Departmental Funding|
|Information Provided By||Melbourne Health|
|Verification Date||February 2009|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP