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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atorvastatin | Active Comparator |
| |
| Lifestyle counseling | Placebo Comparator | Subjects are advised to keep dietary habits according to the National Cholesterol Education Program (NCEP) from the run-in period throughout the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atorvastatin | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Standardized uptake value (SUV) of 18-FDG detected in carotid/aortic atherosclerotic plaques | Baseline and 3 months after intervention |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Makoto Ayaori, MD | Contact | 81429951617 | ayaori@ndmc.ac.jp | |
| Harumi Kondo, PhD | Contact | 81429951617 | harumi@ndmc.ac.jp |
| Name | Affiliation | Role |
|---|---|---|
| Katsunori Ikewaki | National Defense Medical College | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Defense medical College | Recruiting | Tokotozawa | Saitama | 359-8513 | Japan |
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| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D007249 | Inflammation |
| D058226 | Plaque, Atherosclerotic |
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000069059 | Atorvastatin |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
|
| Lifestyle counseling | Behavioral | Subjects are advised to keep dietary habits according to the National Cholesterol Education Program (NCEP) from the run-in period throughout the study. |
|
| 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 |
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020763 | Pathological Conditions, Anatomical |
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D006538 |
| Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |