Efficacy Study of Olmesartan Medoxomil on Coronary Atherosclerosis Progression and Epicardial Adipose Tissue(EAT) Volume Reduction in Patients With Coronary Atherosclerosis Detected by Coronary CT Angiography(CCTA)
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Epicardial Adipose Tissue(EAT) volume detected by CCTA
研究概览
简要总结
The purpose of this study is to determine whether olmesartan medoxomil is effective in the treatment of coronary atherosclerosis progression and epicardial adipose tissue(EAT) volume reduction in patients with coronary atherosclerosis detected by coronary CT angiography(CCTA).
详细描述
Epicardial adipose tissue(EAT) is directly deposited around the pericardium and coronary artery. By means of paracrine action, it can generate various kinds of cytokines, inflammatory factor and free fatty acids, that can affect the state of coronary endothelial function, inflammation and oxidative stress, which finally aggravate the progression of coronary atherosclerosis. In recent years, clinical studies have shown that EAT is a newly discovered independent risk factor of coronary atherosclerosis.Studies confirm that olmesartan medoxomil can improve endothelial function, resisting thrombosis, improve tissue reconstruction, resisting oxidative stress so as to achieve atherosclerosis resistant. Latest researches show that olmesartan medoxomil can better inhibit rat epididymal adipose cell hypertrophy and inflammatory reaction. Coronary CT angiography(CCTA) has emerged as a noninvasive imaging method for analysis coronary atherosclerosis. The purpose of this study is to determine whether olmesartan medoxomil is effective in the treatment of coronary atherosclerosis progression and EAT volume reduction in patients with coronary atherosclerosis detected by CCTA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •coronary artery stenosis between 30% and 70% determined by CCTA in essential hypertension patients
- •resting diastolic blood pressure (DBP) between 90 and 110 mmHg
- •type A and B for coronary artery vascular lesions
排除标准
- •secondary hypertension
- •coronary artery stenosis less than 30% or greater than 70% determined by CCTA
- •contraindications to treatment with olmesartan medoxomil (allergy, glaucoma, digestive ulcer, is currently taking phosphodiesterase-5 inhibitor)
- •resting systolic blood pressure (SBP) > 200 mmHg or resting diastolic blood pressure (DBP) > 110 mmHg
- •Severe calcification, distortion or type C for coronary artery vascular lesions
- •pregnancy
- •unwillingness or inability to provide informed consent
研究组 & 干预措施
Olmesartan medoxomil
Drug: Olmesartan medoxomil tablets(Daiichi Sankyo Inc, Japan). The initial dose is 20mg once daily. If blood pressure requiring further reduction after two weeks, olmesartan medoxomil may be increased to 40mg once daily.
干预措施: Olmesartan medoxomil tablets (Drug)
Antihypertensive medication
Drug:Any antihypertensive medication alone or in combination.Calcium channel blockers (CCBs),diuretics, beta-blockers, or other antihypertensive medication except angiotensin-Converting Enzyme Inhibitors inhibitors (ACEIs) or angiotensin II receptor blockers (ARBs).
The drug dose must be individualized.
干预措施: Antihypertensive medication (per doctor suggestion) (Drug)
结局指标
主要结局
Epicardial Adipose Tissue(EAT) volume detected by CCTA
时间窗: 12 month
Coronary atherosclerosis progression detected by CCTA
时间窗: 12 month
Coronary atherosclerosis progression is defined as ≥10% diameter reduction or progression of a pre-existing coronary stenosis; or ≥0.2mm reduction or progression of the minimal luminal area (MLD) in the lesion
次要结局
- The relationship between coronary atherosclerosis and EAT, as indicated by coronary atherosclerosis progression and epicardial adipose tissue(EAT) volume changes(12 month)
- Serum levels of blood lipids(12 month)
- Serum levels of blood glucose(12 month)
- Circulating surrogate markers of atherosclerosis inflammation including hs-CRP,IL-6,MCP-1,TNF--α and MMP-9(12 month)
- Individual circulating surrogate markers of endothelial function including NO and ET-1(12 month)
- Individual circulating surrogate markers of adipose tissue inflammation and metabolism including adiponectin and leptin.(12 month)
研究者
Yundai Chen
Director of Cardiology,People's Liberation Army General Hospital
Chinese PLA General Hospital