NL-OMON36115
Completed
Not Applicable
Vascular Inflammation in Patients at Risk for Atherosclerotic Disease - VIPER
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- arteriosclerosis
- Sponsor
- Academisch Medisch Centrum
- Enrollment
- 80
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Inclusion criteria
- •Subjects at risk
- •Patients must meet the following criteria for study entry:
- •1\) Patients aged equal to or greater than (\*) 50 years.
- •2\) Patients with an increased risk for cardiovascular disease, as determined by one of the following risk factors:
- •a) LP(a) \> 1200 mg/dl (\> 90th percentile)
- •b) Reduced High density lipoprotein (\< 10th percentile for age and sex),
- •c) Increased LDL cholesterol (LDL \> 90th percentile for age and sex)
- •Age and sex adjusted percentiles tables for LDL and HDL are provided in appendix A.
- •3\) If using a statin, on stable therapy for at least 6 weeks prior to screening with no evidence of statin intolerance.
Exclusion Criteria
- •Subjects may not enter this study if they meet the following criteria: ;1\) Current medical history of Auto\-immune disease/vasculitis, active inflammatory diseases, proven or suspected bacterial infections. Recent (\<1 month prior to screening) or ongoing serious infection requiring IV antibiotic therapy.
- •2\) Use medication for diabetes mellitus, of hypertension.
- •3\) Are known with a BMI \> 28\.
- •4\) Recent or current treatment with medications that may have a significant effect on plaque inflammation as measured by plaque TBR, including but not limited to:
- •\* Steroids for at least 6 weeks prior to baseline measurement and during study (with the exception of inhaled steroids).
- •\* Biological based medicines (anti\-TNF (ex. Infliximab), anti\-IL\-6 therapy (ex. Tocilizumab) or anti\-IL\-1 (ex. anakinra)) within 8 weeks before the baseline visit and during the study
- •\* No other Disease modifying antirheumatic drugs (DMRADS) within 6 weeks of baseline and during study (such as cyclosporine, azatioprine, etc.)
- •5\) Any clinically significant medical condition that could interfere with the conduct of the study.
- •6\) Standard contra\-indications to MRI, 18FDG PET, and CT.
- •7\) Inability or unwillingness to comply with the protocol requirements, or deemed by investigator to be unfit for the study.
Outcomes
Primary Outcomes
Not specified
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