Coronary Artery Disease Clinical Trial
Official title:
The Effect of Inhibition of Interleukin-1 Activity on Vascular and Left Ventricular Function in Patients With Coronary Artery Disease and Coexistent Rheumatoid Arthritis
Verified date | December 2014 |
Source | University of Athens |
Contact | n/a |
Is FDA regulated | No |
Health authority | Greece: Ethics Committee |
Study type | Interventional |
Inhibition of interleukin-1 (IL-1) activity in patients with RA without CAD ameliorates vascular and LV function. Moreover, data from species shows beneficial effect of this treatment on LV function after experimental myocardial infarction. The purpose of this study is to investigate whether anakinra, an IL-1 receptor antagonist, improves vascular and left ventricular (LV) function in patients with coronary artery disease (CAD) and coexistent rheumatoid arthritis (RA).
Status | Completed |
Enrollment | 80 |
Est. completion date | June 2013 |
Est. primary completion date | April 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients with rheumatoid arthritis and coexistent coronary artery disease or without CAD who had an inadequate response to disease modifying antirheumatic drugs (DMARDs) and corticosteroids and were going to initiate treatment with interleukin-1 inhibitor. Exclusion Criteria: - Familiar hyperlipidemia - Diabetes mellitus - Chronic obstructive pulmonary disease or asthma, moderate or severe valvular heart disease, primary cardiomyopathies,malignant tumors |
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Greece | "Attikon" University General Hospital | Haidari, Athens | Attiki |
Lead Sponsor | Collaborator |
---|---|
University of Athens |
Greece,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Improvement in vascular and left ventricular function after anakinra | Improvement in vascular and left ventricular function after administration of anakinra compared to placebo | 3 hours after treatment | No |
Secondary | Reduction of nitrooxidative stress and apoptosis after anakinra treatment | 3 hours after treatment | No |
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