Coronary Disease, Inflammation Plaque, Atherosclerotic, Renin-Angiotensin System
Conditions
Keywords
Fluorodeoxyglucose F18, Positron-Emission Tomography and Computed Tomography, Plaque, Atherosclerotic, Renin-Angiotensin System
Brief summary
The purpose of this study is to evaluate the effects of angiotensin receptor 1 blocker versus calcium channel blocker on atherosclerotic plaque inflammation using serial FDG PET/CT imaging of carotid artery.
Interventions
DRUG6-month treatment
Sponsors
Boryung Pharmaceutical Co., Ltd
CHEOL WHAN LEE, M.D., Ph.D
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Men or Women at least 18 years of age inclusive * Patients with acute coronary syndromes or unstable angina pectoris * Hypertension or blood pressure more than 140/90mmHg * FDG PET/CT shows at least 1 hot uptakes at carotid and or ascending aorta * The patient or guardian agrees to the study protocol and the schedule of clinical and FDG PET/CT follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.
Exclusion criteria
* Patients treated with carotid endarterectomy or stent placement * Chronic disease requiring treatment with oral, intravenous, or intra-articular corticosteroids (use of topical, inhaled, or nasal corticosteroids is permissible). * Untreated hyperthyroidism, or hypothyroidism * Any clinically significant abnormality identified at the screening visit, physical examination, laboratory tests, or electrocardiogram which, in the judgment of the Investigator, would preclude safe completion of the study. * Evidence of congestive heart failure, or left ventricular ejection fraction \< 40%. * Significant renal disease manifested by serum creatinine \> 2.0mg/dL, or creatinine clearance of \< 40 ml/min (by Cockcroft-Gault method). * Hepatic disease or biliary tract obstruction, or significant hepatic enzyme elevation (ALT or AST \> 3 times upper limit of normal). * History of adult asthma manifested by bronchospasm in the past 6 months, or currently taking regular anti-asthmatic medication(s). * Unwillingness or inability to comply with the procedures described in this protocol. * Patient's pregnant or breast-feeding or child-bearing potential. * Type I Diabetes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change (follow-up minus baseline) in standardized FDG uptake value | 6month | change (follow-up minus baseline) in standardized FDG uptake value within the regions of interest, known as a target-to-background ratio (blood-normalized standardized uptake value). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| changes of blood pressure | 6month | systolic and diastolic |
| Serial changes of lipid battery | 6month | total cholesterol, triglyceride, HDL-cholesterol, LDL-cholesterol |
Countries
South Korea
Outcome results
None listed