Effects of Melatonin on Progression of Coronary Artery Calcification
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- a change in CAC score at 6 months measured by coronary CTA
研究概览
简要总结
We planned to evaluate the effects of melatonin on progression of coronary artery calcification (CAC) in patients with moderate calcified coronary atherosclerosis.
详细描述
CAC is prevalent in coronary artery disease (CHD), and the extent of CAC predicts cardiovascular risk. The causes of CAC include dysregulated matrix metabolism, epitaxial mineral deposition, inflammation, oxidative stress, and apoptosis. Melatonin is the main indoleamine produced by the pineal gland; it is known recently to have anti-inflammatory, anti-cancer and antioxidant activities. Several studies have shown that melatonin protects against inflammation and apoptosis in vascular calcification. Melatonin also inhibits oxidative stress-induced apoptosis and calcification in endplate chondrocytes. The investigators planned to determine the efficacy of melatonin on progression of coronary artery calcification (CAC) in patients with moderate calcified coronary atherosclerosis. This study may shed light as to whether oral melatonin supplementation can be an adjunct therapy in CAC patients.
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 (Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a documented Agatston score≥30 and moderate calcified coronary atherosclerosis (<50% diameter lumen narrowing) were eligible for the study.
排除标准
- •unstable angina pectoris
- •symptomatic chronic heart failure and/or left ventricular ejection fraction (EF) <40%
- •atrial fibrillation or other arrhythmias
- •type I diabetes mellitus or uncontrolled type II diabetes mellitus
- •renal failure
- •liver disease
- •gastrointestinal disease that affected absorption
研究组 & 干预措施
Melatonin group
drug: melatonin tablets (Sigma-Aldrich Co. LLC, St. Louis, MO, USA); the frequency:3mg melatonin tablet was taken daily; duration: study treatment was maintained for 6 months.
干预措施: Melatonin 3 mg (Drug)
Control group
drug: placebo tablet; the frequency: placebo tablet was taken daily; duration: study treatment was maintained for 6 months.
干预措施: Placebo (Drug)
结局指标
主要结局
a change in CAC score at 6 months measured by coronary CTA
时间窗: at 6 months
The primary efficacy endpoint was the effect of melatonin on the change in CAC score at 6 months compared with placebo.
次要结局
- malondialdehyde (MDA) level(at 6 months)
- high-sensitivity C-reactive protein (hsCRP) level(at 6 months)
研究者
Chen Wei Ren, MD
Prof.
Chinese PLA General Hospital