Vascular Inflammation in Patients at Risk for Atherosclerotic Disease

Completed

Conditions: 10047066
arteriosclerosis
atherosclerosis

Registration Number: NL-OMON36115

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 80

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.
4) For patients taking angiotensin-converting enzyme (ACE) inhibitors (ACE-I) or angiotensin-receptor blockers (ARBs), non-statin lipid-modifying therapy, thiazolidinediones, inhaled steroids, or leukotriene modifying agents, use of a stable dose for at least 6 weeks prior to baseline measurement.
5) Stable Nonsteroidal anti-inflammatory drugs (NSAIDS), Cyclo-oxygenase-2 inhibitors (COXIBs) for at least 6 weeks prior to baseline measurement.
6) Subject agrees to the restrictions as described in paragraph 4.6. In brief: subjects are not permitted any alcohol or caffeine-containing food or drinks from 12 hrs prior to study visits until discharge. In addition, no strenuous exercise is permitted for 24 hrs before the study visits.;Healthy controls
Healthy controls must meet the following criteria for study entry:
1) Healthy subjects aged > 50 years of age.
2) Subjects with baseline levels of the following risk factors between the 35 - 65th percentile.
a) LP(a)
b) High density lipoprotein
c) LDL cholesterol
3) No use of systemic medication
4) No history of cardiovascular disease
5) Subject agrees to the restrictions as described in paragraph 4.6. In brief: subjects are not permitted any alcohol or caffeine-containing food or drinks from 12 hrs prior to study visits until discharge. In addition, no strenuous exercise is permitted for 24 hrs before the study visits.

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.
8) Subject has planned cardiac surgery, PCI or carotid stenting, or major non-cardiac surgery during the course of the study period or for 14 days after the last treatment.