Atherosclerosis, Inflammation
Conditions
Keywords
atherosclerotic plaques, hypercholesterolemia, HMG-CoA reductase inhibitor, statin, lipid-lowering therapy
Brief summary
The purpose of this study is to determine whether HMG-CoA reductase inhibitor, atorvastatin attenuates inflammation in atherosclerotic plaques detected by 18F-fluorodeoxyglucose(FDG) PET.
Interventions
DRUGAtorvastatin
Subjects are advised to keep dietary habits according to the National Cholesterol Education Program (NCEP) from the run-in period throughout the study. The subjects are administered with 10mg/day for 3 months, if LDL-cholesterol levels does not decrease less than 80mg/dl, the dose is increased up to 20mg/day. If LDL-cholesterol levels decrease less than 60mg/dl, the dose is decreased down to 5mg/day or less.
BEHAVIORALLifestyle counseling
Subjects are advised to keep dietary habits according to the National Cholesterol Education Program (NCEP) from the run-in period throughout the study.
Sponsors
National Defense Medical College, Japan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Subjects with accumulation of FDG-PET in carotid artery or aorta
Exclusion criteria
* LDL cholesterol level (calculated by using Friedewald formula) higher than 180 mg/dl or less than 120 mg/dl * subjects currently taking HMG CoA-reductase (Statins) or fibrates * symptomatic coronary artery diseases * symptomatic cerebrovascular diseases * subjects suffered from myocardial infarction or stroke within 6 months * subjects underwent percutaneous vascular interventions or vascular operations within 6 months * diabetic patients with poor glycemic control (HbA1c\>8.5) * hypertensive patients with poor blood pressure control * subjects with neoplasms * subjects with systemic inflammatory diseases
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Standardized uptake value (SUV) of 18-FDG detected in carotid/aortic atherosclerotic plaques | Baseline and 3 months after intervention |
Secondary
| Measure | Time frame |
|---|---|
| Flow-mediated vasodilation of brachial artery determined by ultrasonography | Baseline and 3 months after intervention |
| Serum markers for inflammation such as high-sensitive CRP, IL-6 or soluble ICAM-1 | Baseline and 3 months after intervention |
| Serum and urine markers for anti- or pro-oxidant stress such as oxidized LDL or 8-Hydroxydeoxyguanosine | Baseline and 3 months after intervention |
| Max-intima-media thickness (Max-IMT), Mean-IMT and plaque score determined by carotid artery ultrasonography | Baseline and 3 months after intervention |
| Serum lipids such as total cholesterol, LDL-cholesterol, HDL-cholesterol, RLP-cholesterol and triglycerides | Baseline and 3 months after intervention |
Countries
Japan
Contacts
Primary ContactMakoto Ayaori, MD
Backup ContactHarumi Kondo, PhD
Outcome results
None listed